B05678 Rev.

2/04-16

BARD® LIFESTENT® Vascular Stent System

Recommended Guidewire Length Table
Catheter Recommended Guidewire
Working Length Length
130 cm 300 cm
80 cm 260 cm

160 cm & 110 cm

8
130 cm & 80 cm
1 4
2

5 7 3 6
11
9 10
Figure 1. LIFESTENT® Vascular Stent System

CAUTION: Federal (USA) law restricts this device to sale by or on order of a physician.

This device is supplied in sterile condition. All materials inside the sterile barrier pouch (the delivery system
and stent, as shown in Figure 1, as well as the tray and pouch liner) are sterile. The external surface of the
sterile barrier pouch, as well as the product carton, should not be considered sterile.

A. Device Description
The LIFESTENT® Vascular Stent System is designed to deliver a self-expanding stent to the peripheral vasculature via a sheathed delivery
system. The LIFESTENT® Vascular Stent System is comprised of the following:
An implantable self-expanding nickel-titanium alloy (nitinol) stent (1), as shown in Figure 1 and Figure 2. The stent is a flexible, fine tubular
mesh prosthesis, with a helical design, which achieves its unconstrained diameter upon deployment into the target vessel. Upon deployment,
the stent imparts an outward radial force on the luminal surface of the vessel to establish patency. The stent has a total of 12 tantalum
radiopaque markers (Figure 2, items 1A & 1B) located on the ends of the stent (i.e., 6 at each end).
A delivery system, as shown in Figure 1, is comprised of an inner tubing assembly that contains the guidewire lumen, a stent delivery sheath
(2) and a system stability sheath (3), which are linked together by means of a handle (4). The guidewire lumen terminates distally in an
atraumatic catheter tip (5) and originates proximally in a luer hub (6) designed to accept a compatible guidewire. The self-expanding stent
(1) is constrained in the space between the guidewire lumen and stent delivery sheath. Unintended stent movement during sheath retraction
is restricted by the delivery system. The stent delivery sheath has a radiopaque zone (7) at its distal end. Prior to deployment, the shipping
lock (8) must be removed and discarded.
Refer to “Stent Deployment Procedure, Section 4. Deploy Stent” for directions on deploying the stent with the:
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Figure 2. Vascular Stent

1
B. Indication for Use
The LIFESTENT® Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions
up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from
4.0 - 6.5 mm.

C. Contraindications
The LIFESTENT® Vascular Stent System is contraindicated for use in:
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stent delivery system.

D. Warnings
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may have been compromised. The temperature exposure indicator label should be grey and must be clearly visible on the pouch.
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š '2127XVHZLWK(THIODOL™ or Lipiodol contrast media.
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š If multiple stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol).
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E. Precautions
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unit.
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š &DVHVRIIUDFWXUHKDYHEHHQUHSRUWHGLQFOLQLFDOXVHRIWKHLIFESTENT® Vascular Stent. Cases of stent fracture occurred in lesions that were
moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10% elongation at
deployment. Therefore, care should be taken when deploying the stent as manipulation of the delivery system may, in rare instances, lead
to stent elongation and subsequent stent fracture. The long-term clinical implications of these stent fractures have not yet been
established (see section J).
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F. Magnetic Resonance Imaging (MRI) Compatibility

Conditions for All Stents
1RQFOLQLFDOWHVWLQJKDVGHPRQVWUDWHGWKDWWKHLIFESTENT® Vascular Stent is MR Conditional for vascular placement in lesions up to a length
of 240 mm. It can be scanned safely under the following conditions:
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umbilicus, a whole body SAR up to 2 W/kg may be applied.
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2
3.0 Tesla Temperature Rise
Under the scan conditions defined above, the LIFESTENT® Vascular Stent is expected to produce a maximum temperature rise in the patient of
2.7 °C after 15 minutes of continuous scanning.

1.5 Tesla Temperature Rise

Under the scan conditions defined above, the LIFESTENT® Vascular Stent is expected to produce a maximum temperature rise in the patient of
3.0 °C after 15 minutes of continuous scanning.

Image Artifact
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the stent. Artifact
tests were performed according to ASTM F2182-11a. Maximum artifact extended 3 mm beyond the stent for the spin echo sequence and
10 mm for the gradient echo sequence. The lumen was obscured.

Additional Information
The LIFESTENTŪ9DVFXODU6WHQWKDVQRWEHHQHYDOXDWHGLQ05,V\VWHPVRWKHUWKDQRU7HVOD7KHKHDWLQJHijHFWLQWKH05,HQYLURQPHQW
for fractured stents is not known. The presence of other implants or the health state of the patient may require reduction of the MRI limits
listed above.

G. Overview of Clinical Studies

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LIFESTENT® Vascular Stent System to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic vascular disease of the
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DW86DQG(XURSHDQFHQWHUV,QWRWDOVXEMHFWVZHUHUDQGRPL]HGWRWKHWHVWDUP WUHDWPHQWZLWKWKHLIFESTENT® Vascular Stent System)
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for a total of three years following the index procedure.

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LIFESTENT® and LIFESTENTŪ ;/ 9DVFXODU 6WHQW 6\VWHPV  VXEMHFWV ZHUH WUHDWHG LQ  (XURSHDQ FHQWHUV 7KH SULPDU\ VDIHW\ HQGSRLQW ZDV
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followed for 30 days following the index procedure.

A retrospective analysis of the performance of the LIFESTENT® Vascular Stent Systems for long-segment lesions was also undertaken.
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acute safety (freedom from death, amputation or TVR) at 30-days, long-term safety (freedom from death or amputation) at 12 months
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200 mm and 240 mm.

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and placement accuracy based upon a rating scale completed by the investigators at time of index procedure. Primary safety was defined as
freedom from occurrence of death, amputation and TVR/TLR at 30 days post-index procedure.

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Stent Systems to percutaneous transluminal angioplasty (PTA) in the treatment of patients with stenosis and occlusion of the popliteal artery.
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H. Adverse Events
a. OBSERVED ADVERSE EVENTS
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3
 RESILIENT Trial Adverse Event Summary
RESILIENT Randomized RESILIENT Feasibility
LIFESTENT® (N=134) PTA (N=72) LIFESTENT® (N=20)
Event % (N pts) [N events] % (N pts) [N events] % (N pts) [N events]
In-Hospital Events
0DMRU$GYHUVH(YHQWV 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Death 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Myocardial Infarction 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Target Limb Loss / Amputation 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
TVR 0 (0/134) [0] 41.7 (30/72) [31] 5.0 (1/20) [1]
TLR 0 (0/134) [0] 41.7 (30/72) [30] 0 (0/20) [0]
1RQ7/5 0 (0/134) [0] 1.4 (1/72) [1] 5.0 (1/20) [1]
Stroke/CVA 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
'LVWDO(PEROL]DWLRQ 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Access Site Bleeding / Hematoma 0.7 (1/134) [1] 0 (0/72) [0] 5.0 (1/20) [1]
Blood Loss requiring Transfusion 1.5 (2/134) [2] 1.4 (1/72) [1] 0 (0/20) [0]
Vessel Perforation 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Vessel Aneurysm 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Vessel Pseudo-Aneurysm 0 (0/134) [0] 1.4 (1/72) [1] 5.0 (1/20) [1]
Vessel Dissection 4.5 (6/134) [6] 20.8 (15/72) [16] 5.0 (1/20) [1]
Thrombosis 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Events at 30-Days
0DMRU$GYHUVH(YHQWV 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Death 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Myocardial Infarction 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Target Limb Loss / Amputation 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
TVR 0.7 (1/134) [2] 41.7 (30/72) [31] 5.0 (1/20) [1]
TLR 0.7 (1/134) [1] 41.7 (30/72) [30] 0 (0/20) [0]
1RQ7/5 0.7 (1/134) [1] 1.4 (1/72) [1] 5.0 (1/20) [1]
Stroke/CVA 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
'LVWDO(PEROL]DWLRQ 0 (0/134) [0] 1.4 (1/72) [1] 0 (0/20) [0]
Access Site Bleeding / Hematoma 0.7 (1/134) [1] 1.4 (1/72) [1] 5.0 (1/20) [1]
Blood Loss requiring Transfusion 1.5 (2/134) [2] 2.8 (2/72) [2] 0 (0/20) [0]
Vessel Perforation 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Vessel Aneurysm 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Vessel Pseudo-Aneurysm 0 (0/134) [0] 1.4 (1/72) [1] 5.0 (1/20) [1]
Vessel Dissection 4.5 (6/134) [6] 20.8 (15/72) [16] 5.0 (1/20) [1]
7KURPERVLV +UV'D\V2QO\ 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Events at 12-Months
0DMRU$GYHUVH(YHQWV 8.2 (11/134) [13] 6.9 (5/72) [6] 5.0 (1/20) [1]
Death 3.7 (5/134) [5] 2.8 (2/72) [2] 0 (0/20) [0]
Myocardial Infarction 4.5 (6/134) [8] 1.4 (1/72) [1] 5.0 (1/20) [1]
Target Limb Loss / Amputation 0 (0/134) [0] 4.2 (3/72) [3] 0 (0/20) [0]
TVR 16.4 (22/134) [28] 54.2 (39/72) [54] 15.0 (3/20) [3]
TLR 11.9 (16/134) [16] 54.2 (39/72) [46] 10.0 (2/20) [2]
1RQ7/5 8.2 (11/134) [12] 8.3 (6/72) [8] 5.0 (1/20) [1]
Stroke/CVA 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Vessel Aneurysm 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Vessel Pseudo-Aneurysm 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
/DWH7KURPERVLV !'D\V2QO\ 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]

4
 RESILIENT Trial Adverse Event Summary
RESILIENT Randomized RESILIENT Feasibility
LIFESTENT® (N=134) PTA (N=72) LIFESTENT® (N=20)
% (N pts) % (N pts) % (N pts)
Event [N events] [N events] [N events]
Events at 24-Months
0DMRU$GYHUVH(YHQWV 13.4 (18/134) [23] 11.1 (8/72) [11] 5.0 (1/20) [1]
Death 7.5 (10/134) [10] 5.6 (4/72) [4] 0 (0/20) [0]
Myocardial Infarction 6.0 (8/134) [11] 5.6 (4/72) [4] 5.0 (1/20) [1]
Target Limb Loss / Amputation 1.5 (2/134) [2] 4.2 (3/72) [3] 0 (0/20) [0]
TVR 25.4 (34/134) [48] 58.3 (42/72) [69] 15.0 (3/20) [4]
TLR 20.1 (27/134) [30] 56.9 (41/72) [53] 10.0 (2/20) [3]
1RQ7/5 12.7 (17/134) [18] 15.3 (11/72) [16] 5.0 (1/20) [1]
Stroke/CVA 0.7 (1/134) [1] 0 (0/72) [0] 0 (0/20) [0]
Vessel Aneurysm 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Vessel Pseudo-Aneurysm 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
/DWH7KURPERVLV !'D\V2QO\ 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Latest Data Available 36-Months 36-Months 36-Months
0DMRU$GYHUVH(YHQWV 15.7 (21/134) [27] 11.1 (8/72) [12] 10.0 (2/20) [2]
Death 9.0 (12/134) [12] 6.9 (5/72) [5] 0 (0/20) [0]
Myocardial Infarction 7.5 (10/134) [13] 5.6 (4/72) [4] 10.0 (2/20) [2]
Target Limb Loss / Amputation 1.5 (2/134) [2] 4.2 (3/72) [3] 0 (0/20) [0]
TVR 28.4 (38/134) [57] 58.3 (42/72) [71] 15.0 (3/20) [4]
TLR 21.6 (29/134) [35] 56.9 (41/72) [54] 10.0 (2/20) [3]
1RQ7/5 15.7 (21/134) [22] 16.7 (12/72) [17] 5.0 (1/20) [1]
Stroke/CVA 1.5 (2/134) [2] 0 (0/72) [0] 0 (0/20) [0]
Vessel Aneurysm 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
Vessel Pseudo-Aneurysm 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]
/DWH7KURPERVLV !'D\V2QO\ 0 (0/134) [0] 0 (0/72) [0] 0 (0/20) [0]

7KHIROORZLQJDGYHUVHHYHQWVZHUHGRFXPHQWHGGXULQJWKHFRXUVHRIWKH(7$*,866WULDO 1  

E-TAGIUSS Trial Adverse Event Summary

Event In-Hospital 30 Day
0DMRU$GYHUVH(YHQW 0% (0/37) 0% (0/37)
Death 0% (0/37) 0% (0/37)
Myocardial Infarction 0% (0/37) 0% (0/37)
Target Limb Loss 2.7% (1/37) 2.7% (1/37)
Target Lesion Revascularization (TLR) 0% (0/37) 0% (0/37)
Stent Thrombosis 0% (0/37) 0% (0/37)
'LVWDO(PEROL]DWLRQ 2.7% (1/37) 2.7% (1/37)
Access Site Bleeding 2.7% (1/37) 2.7% (1/37)
1RQ$FFHVV6LWH%OHHGLQJ 0% (0/37) 0% (0/37)
Vessel Perforation 0% (0/37) 0% (0/37)
Vessel Aneurysm 0% (0/37) 0% (0/37)
Vessel Pseudo-Aneurysm 0% (0/37) 0% (0/37)
Vessel Dissection 0% (0/37) 0% (0/37)

5
 ETAP Trial Safety Events
P1 P2/P3
Number (%) pts Number (%) pts
p-value p-value
PTA/Stent (N=9) Stent (N=36) PTA/Stent (N=22) Stent (N=85)
Severe
Cardiovascular Events*
12 month 3 (37.5%) 8 (22.9%) 0.4010 6 (31.6%) 19 (25.7%) 0.5770
(YDOXDEOH6XEMHFWVA 1  1  1  1 
24 month 4 (50.0%) 9 (31.0%) 0.4132 6 (40.0%) 22 (34.9%) 0.7689
(YDOXDEOH6XEMHFWVA 1  1  1  1 
Adverse Events**
12 month 7 (77.8%) 18 (51.4%) 0.2600 13 (61.9%) 43 (56.6%) 0.8510
(YDOXDEOH6XEMHFWVA 1  1  1  1 
24 month 7 (77.8%) 23 (76.7%) 1.0000 16 (80.0%) 45 (65.2%) 0.3270
(YDOXDEOH6XEMHFWVA 1  1  1  1 

Death***
12 month 0 (0.0%) 1 (3.0%) 1.0000 1 (5.3%) 2 (2.7%) 0.4962
(YDOXDEOHVXEMHFWVA 8 33 19 75
24 month 0 (0.0%) 3 (11.5%) 1.0000 2 (12.5%) 4 (7.0%) 0.6065
(YDOXDEOH6XEMHFWVA 8 26 16 57

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*** P1 and P2/P3 subset compliance was not stratified at the 24 month interval due to the fact that the deaths verified from Protocol Version
1.0 could not be confirmed to specific patient ID numbers.
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b. POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur include, but are not limited to, the following:
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I. Clinical Studies
a. RESILIENT FEASIBILITY STUDY
7KH5(6,/,(17VWXG\LQFOXGHGDIHDVLELOLW\VWXG\WRDVVHVVWKHVDIHW\RIWKHLIFESTENT® Vascular Stent System. This feasibility study enrolled
VXEMHFWVDWVL[86LQYHVWLJDWLYHVLWHV5HVXOWVIURPWKLVVWXG\SURYLGHGMXVWLıFDWLRQIRULQLWLDWLRQRIDSLYRWDOVWXG\WRDVVHVVWKHVDIHW\DQG
HijHFWLYHQHVVRIWKHLIFESTENT® Vascular Stent System.

b. RESILIENT RANDOMIZED STUDY

Design
7KH5(6,/,(17WULDOZDVDSURVSHFWLYHPXOWLFHQWHUUDQGRPL]HGFOLQLFDOLQYHVWLJDWLRQWRHYDOXDWHWKHVXSHULRULW\RIWKHLIFESTENT® Vascular
Stent System compared to PTA in the treatment of symptomatic vascular disease of the SFA and/or proximal popliteal artery. A total of 206
VXEMHFWVZHUHWUHDWHGDW86DQG(XURSHDQLQYHVWLJDWLYHVLWHV(DFKVLWHQRWSDUWLFLSDWLQJLQWKHIHDVLELOLW\VWXG\ZDVUHTXLUHGWRSHUIRUP
RQHUROOLQFDVH$WRWDORIUROOLQFDVHVZHUHSHUIRUPHGDQGUDQGRPL]HGFDVHVZHUHSHUIRUPHG6HYHQW\WZR  VXEMHFWVZHUH
UDQGRPL]HGWRWKH37$DUPDQGVXEMHFWVZHUHUDQGRPL]HGWRWUHDWPHQWZLWKWKHLIFESTENT® Vascular Stent System.
6XEMHFWVHOLJLEOHWREHHQUROOHGLQWKLVVWXG\KDGVWHQRWLFRURFFOXGHGOHVLRQVRIWKH6)$DQGRUSUR[LPDOSRSOLWHDODUWHU\DQGVXijHUHGIURPOLIHVW\OH
OLPLWLQJFODXGLFDWLRQ 5XWKHUIRUG&DWHJRU\ş /HVLRQVFRXOGEHHLWKHUGHQRYRRUUHVWHQRWLF6XEMHFWVZLWKSUHYLRXVO\VWHQWHGOHVLRQVRUWDUJHW
OLPE YDVFXODU E\SDVV ZHUH H[FOXGHG 5HIHUHQFH YHVVHO GLDPHWHU 59'  RI WKH WUHDWHG VXEMHFWV ZDV WR EH  ş  PP LQ GLDPHWHU DQG WKH
FROOHFWLYH OHQJWK RI WKH WUHDWHG VHJPHQW ZDV WR EH OHVV WKDQ  PP 6XEMHFWV XQGHUZHQW DQJLRJUDSKLF DQDO\VLV RI WKH OHVLRQ SULRU WR DQG
LPPHGLDWHO\IROORZLQJWUHDWPHQW6XEMHFWVZHUHIROORZHGDWGD\VPRQWKVDQGDQQXDOO\WKHUHDIWHUZLWKIROORZXSSODQQHGRXWWRPRQWKV
2ĴFHYLVLWVZHUHFRXSOHGZLWKGXSOH[XOWUDVRXQGDVVHVVPHQWVRIWKHWUHDWHGVHJPHQWV;UD\HYDOXDWLRQRIWKHVWHQWHGOHVLRQVZDVDOVRSHUIRUPHG
7KH5(6,/,(17WULDOXWLOL]HGD)UHTXHQWLVWDSSURDFKZLWKLWVVWDWLVWLFDOSODQ7KHSULPDU\REMHFWLYHVZHUHWRVKRZWKHIROORZLQJ

š WKDWWKHSUREDELOLW\RIWKHRFFXUUHQFHRI7DUJHW/HVLRQ5HYDVFXODUL]DWLRQ 7/5 RU7DUJHW9HVVHO5HYDVFXODUL]DWLRQ 795 DWPRQWKVSRVW

SURFHGXUHIRUWKHVXEMHFWVWUHDWHGZLWKLIFESTENTŪ176WHQW6\VWHP WHVWDUP ZDVVLJQLıFDQWO\ORZHUWKDQ DQGWKHUHIRUHVXSHULRUWR WKDW
IRUWKHVXEMHFWVWUHDWHGZLWK37$DORQH FRQWURODUP DQG
š WKDWWKHGHDWKUDWHVDWGD\VSRVWSURFHGXUHZHUHQRWVLJQLıFDQWO\GLijHUHQWEHWZHHQWKHWHVWDUPDQGWKHFRQWURODUP

Continuous variables were compared using an independent samples t-test. Dichotomous variables were compared using Fisher‘s exact test.
2UGLQDOYDULDEOHVZHUHFRPSDUHGXVLQJD&KLVTXDUHWHVW7LPHWRHYHQWZDVFRPSDUHGXVLQJDORJUDQNWHVW,QWHUYDOFHQVRUHGGDWDZHUH
analyzed using the Kaplan-Meier method as the primary analysis. A sensitivity analysis for interval censored data was performed using the
:HLEXOOGLVWULEXWLRQ(ijHFWLYHQHVVHQGSRLQWVZHUHDQDO\]HGDVRQHVLGHGWHVWV6DIHW\HQGSRLQWVZHUHDQDO\]HGDVWZRVLGHGWHVWV

7KHUHVXOWVZHUHHYDOXDWHGXVLQJDQ,QWHQWWR7UHDW ,77 DQDO\VLV,QSDUWLFXODUFRQWUROVXEMHFWVUHTXLULQJVWHQWSODFHPHQWWRVDOYDJHDIDLOHG

angioplasty remained in the cohort to which they were randomized.

7
Demographics
&KDUDFWHULVWLFVRIWKHVXEMHFWVHQUROOHGLQWKHVWXG\LQFOXGLQJDJHJHQGHUPHGLFDOKLVWRU\DVZHOODVOHVLRQFKDUDFWHULVWLFVDUHSURYLGHGLQ
the tables below.

RESILIENT Trial Subject Demographics

Variable Category Test Control
$JHDW3URFHGXUH <UV 10HDQƄ6' Ƅ Ƅ
Female 29.1 (39/134) 33.3 (24/72)
*HQGHU Q1
Male 70.9 (95/134) 66.7 (48/72)
African American 9.0 (12/134) 9.7 (7/72)
5DFH Q1 Caucasian 89.6 (120/134) 84.7 (61/72)
2WKHU 1.5 (2/134) 5.6 (4/72)
+\SHUWHQVLRQ Q1 83.6 (112/134) 94.4 (68/72)
+\SHUFKROHVWHUROHPLD Q1 79.9 (107/134) 76.4 (55/72)
'LDEHWHV Q1 38.1 (51/134) 38.9 (28/72)
6PRNLQJ Q1 72.4 (97/134) 83.3 (60/72)
&RURQDU\$UWHU\'LVHDVH Q1 56.0 (75/134) 54.2 (39/72)
0\RFDUGLDO,QIDUFWLRQ Q1 20.1 (27/134) 26.4 (19/72)
Class 1 3.0 (4/134) 6.9 (5/72)
Class 2 35.8 (48/134) 41.7 (30/72)
7DUJHW/LPE5XWKHUIRUG&DWHJRU\ Q1
Class 3 61.2 (82/134) 50.0 (36/72)
Class 5 1.4 (1/72)
Target Limb ABI (mm Hg) 10HDQƄ6' Ƅ Ƅ
Contralateral Limb ABI (mm Hg) 10HDQƄ6' Ƅ Ƅ

RESILIENT Trial Lesion Characteristics

Variable Category Test Control
1 Lesion(s) 85.8 (115/134) 87.5 (63/72)
1XPEHURI/HVLRQV Q1
2 Lesion(s) 14.2 (19/134) 12.5 (9/72)
Left 47.7 (73/153) 54.3 (44/81)
7DUJHW6LGH Q1
Right 52.3 (80/153) 45.7 (37/81)
Proximal 1/3 of SFA 13.1 (20/153) 14.8 (12/81)
Middle 1/3 of SFA 32.0 (49/153) 38.3 (31/81)
/HVLRQ/RFDWLRQ Q1
Distal 1/3 of SFA 50.3 (77/153) 45.7 (37/81)
Proximal Popliteal 4.6 (7/153) 1.2 (1/81)
'H1RYR6WHQRVHG 80.4 (123/153) 79.0 (64/81)
/HVLRQ&ODVVLıFDWLRQ Q1 2FFOXVLRQ 17.0 (26/153) 18.5 (15/81)
Restenosed 2.6 (4/153) 2.5 (2/81)
Target Vessel RVD (mm) 10HDQƄ6' Ƅ Ƅ
Lesion % Diameter Stenosis 10HDQƄ6' Ƅ Ƅ
Lesion Length (mm) 10HDQƄ6' Ƅ Ƅ

8
Methods
6XEMHFWVXQGHUZHQWHLWKHU37$RU37$SOXVLIFESTENT® Vascular Stent System placement in the target lesion(s). In cases where the PTA only
UHVXOWZDVVXERSWLPDOVWHQWSODFHPHQWZDVSHUIRUPHG7KLVRFFXUUHGLQ  RIWKHVXEMHFWVWKDWZHUHUDQGRPL]HGWRWKH37$RQO\
treatment arm. Post procedure medication was suggested as aspirin for 6 months and clopidogrel for 12 weeks.
$OOGDWDZHUHFROOHFWHGRQFDVHUHSRUWIRUPVDWLQYHVWLJDWLYHVLWHV$GYHUVHHYHQWVZHUHDGMXGLFDWHGE\WKHFOLQLFDOHYHQWVFRPPLWWHHDQGWKH
data safety monitoring board routinely reviewed the study outcomes to ensure that the benefits of continuing the study outweighed any
potential risks. Independent core laboratories were utilized to analyze angiographic, x-ray and duplex imaging.

Results
$VVKRZQLQWKHSULQFLSDO6DIHW\DQG(ijHFWLYHQHVVWDEOH 6HFWLRQ- WKHLIFESTENT® Vascular Stent System demonstrated a significantly higher
freedom from intervention rate (freedom from TVR/TLR) at 6 months (LIFESTENTŪFRQWURO PRQWKV LIFESTENTŪFRQWURO
45.2% ), 24 months (LIFESTENTŪFRQWURO DQGPRQWKV LIFESTENTŪFRQWURO WKDQWKH37$FRQWUROJURXS S 
$GGLWLRQDOO\DVH[SHFWHGWKHUHZDVQRGLijHUHQFHLQWKHGD\PRUWDOLW\UDWHEHWZHHQWKHWZRVWXG\DUPV

c. E-TAGIUSS CONFIRMATORY STUDY

Design
7KH(7$*,866WULDOZDVDSURVSHFWLYHPXOWLFHQWHUFRQıUPDWRU\FOLQLFDOLQYHVWLJDWLRQWRHYDOXDWHWKHLIFESTENT® and LIFESTENT® XL Vascular
6WHQW6\VWHPVLQWKHWUHDWPHQWRIV\PSWRPDWLFYDVFXODUGLVHDVHRIWKH6)$DQGSUR[LPDOSRSOLWHDODUWHU\$WRWDORIVXEMHFWVZHUHWUHDWHG
DW(XURSHDQLQYHVWLJDWLYHVLWHV

6XEMHFWVHOLJLEOHWREHHQUROOHGLQWKLVVWXG\KDGWRGHPRQVWUDWH7UDQV$WODQWLF,QWHU6RFLHW\&RQVHQVXV 7$6& $%RU&OHVLRQV5HIHUHQFH

YHVVHOGLDPHWHU 59' RIWKHWUHDWHGVXEMHFWVZDVWREHşPPLQGLDPHWHUDQGWKHFROOHFWLYHOHQJWKRIWKHWUHDWHGVHJPHQWZDVWR
EHOHVVWKDQPP6XEMHFWVXQGHUZHQWDQJLRJUDSKLFDQDO\VLVRIWKHOHVLRQSULRUWRDQGLPPHGLDWHO\IROORZLQJWUHDWPHQW6XEMHFWVZHUH
IROORZHGDWGD\VZLWKDQRĴFHYLVLW

Demographics
&KDUDFWHULVWLFVRIWKHVXEMHFWVHQUROOHGLQWKHVWXG\LQFOXGLQJDJHJHQGHUPHGLFDOKLVWRU\DVZHOODVOHVLRQFKDUDFWHULVWLFVDUHSURYLGHGLQ
the tables below.

E-TAGIUSS Trial Subject Demographics

Variable Category Total
$JHDW3URFHGXUH <UV 0HDQƄ6' 1 Ƅ
Female 29.7 (11/37)
*HQGHU Q1
Male 70.3 (26/37)
Caucasian 97.3 (36/37)
5DFH Q1
2WKHU 2.7 (1/37)
+\SHUWHQVLRQ Q1 83.8 (31/37)
+\SHUFKROHVWHUROHPLD Q1 56.8 (21/37)
6PRNLQJ Q1 48.6 (18/37)
&RURQDU\$UWHU\'LVHDVH Q1 32.4 (12/37)
'LDEHWHV Q1 24.3 (9/37)
0\RFDUGLDO,QIDUFWLRQ Q1 13.5 (5/37)
Class 1 5.4 (2/37)
Class 2 35.1 (13/37)
7DUJHW/LPE5XWKHUIRUG&DWHJRU\ Q1 Class 3 45.9 (17/37)
Class 4 5.4 (2/37)
Class 5 8.1 (3/37)
Target Limb ABI (mm Hg) 0HDQƄ6' 1 Ƅ
Contralateral Limb ABI (mm Hg) 0HDQƄ6' 1 Ƅ

9
 E-TAGIUSS Trial Lesion Characteristics

Variable Category Total

1 86.5 (32/37)
1XPEHURI/HVLRQV Q1
2 13.5 (5/37)

Left 47.6 (20/42)

7DUJHW6LGH Q1
Right 52.4 (22/42)

Popliteal 2.4 (1/42)

/HVLRQ/RFDWLRQ Q1 SFA 95.2 (40/42)

SFA & Popliteal 2.4 (1/42)

2FFOXVLRQ 42.9 (18/42)

Reoccluded 7.1 (3/42)

/HVLRQ&ODVVLıFDWLRQ Q1
Restenosed 2.4 (1/42)

Stenosed 47.6 (20/42)

TASC A 45.9 (17/37)

/HVLRQ6HYHULW\7$6&*UDGH Q1 TASC B 24.3 (9/37)

TASC C 29.7 (11/37)

Target Vessel RVD (mm) 10HDQƄ6' Ƅ

Lesion % Diameter Stenosis 10HDQƄ6' Ƅ

Lesion Length (mm) 10HDQƄ6' Ƅ

Methods
6XEMHFWVXQGHUZHQW37$SOXVLIFESTENT® and/or LIFESTENT® XL Vascular Stent placement in the target lesion(s). Post procedure medication was
suggested as aspirin and clopidogrel for a minimum of 30 days.

$OOGDWDZHUHFROOHFWHGRQFDVHUHSRUWIRUPVDWLQYHVWLJDWLYHVLWHV$GYHUVHHYHQWVZHUHDGMXGLFDWHGE\WKHFOLQLFDOHYHQWVFRPPLWWHHDQGWKH
data safety monitoring board reviewed the study outcomes. Independent core laboratories were utilized to analyze angiographic data.

Results
$VVKRZQLQWKHSULQFLSDO6DIHW\DQG(ijHFWLYHQHVVWDEOH 6HFWLRQ- WKHLIFESTENT® and LIFESTENT® XL Vascular Stent Systems were able to
accurately deploy the stent and demonstrated minimal length change (deployment success 100.0%). Additionally, the acute safety and
HijHFWLYHQHVVPHDVXUHVGHPRQVWUDWHGSRVLWLYHUHVXOWV

d. RETROSPECTIVE ANALYSIS OF LIFESTENT® VASCULAR STENT SYSTEMS IN THE TREATMENT OF LONG-SEGMENT LESIONS

Design
7KLVVWXG\FRQVLVWHGRIDSRVWKRFDQDO\VLVRIIRXUVRXUFHVRIGDWD  DSLYRWDO,'(FOLQLFDOWULDO 5(6,/,(17,'(*ŗ5(6,/,(17Ř 
 DPXOWLFHQWHUQRQUDQGRPL]HGREVHUYDWLRQDOVWXG\FRQGXFWHGLQ(XURSH ŗ(/2',(,Ř   WKHURXWLQHFOLQLFDOSUDFWLFHRID8QLWHG6WDWHV
86 SK\VLFLDQ ŗ866HULHVŘ DQG  WKHURXWLQHFOLQLFDOSUDFWLFHRID(XURSHDQ8QLRQ (8 SK\VLFLDQ ŗ(86HULHVŘ ,QWRWDOWZRKXQGUHGHLJKW\
five (285) patients with one or more implanted LIFESTENT® devices were identified and included in the analysis. There were a total of 46 lesion
segments in this analysis with lesion lengths beyond 160 mm.

Demographics
&KDUDFWHULVWLFVRIWKHVXEMHFWVDQGOHVLRQVDQDO\]HGDUHSURYLGHGLQWKHWDEOHVEHORZ

10
 Demographics: Retrospective Analysis of LIFESTENT® Vascular Stent Systems in the Treatment of Long-Segment Lesions
Characteristic RESILIENT ELODIE I US Series EU Series TOTAL
Age at Procedure (years)
1UHSRUWHG 198 11 66 10 285
Mean 68.4 71.8 72.6 73.9 69.7
St Dev 10.2 8.63 10.9 5.53 10.3
Range 20.7 – 88.2 53.9 - 85.6 36.3 - 96.8 63.9 - 83.1 20.7 – 96.8
Gender (% male) 69.2 45.5 60.6 44.4 65.5
1UHSRUWHG 198 11 66 9 284
Race (% Caucasian) 88.9 100 77.3 100 86.6
1UHSRUWHG 198 3 66 10 277
Hypertension (%) 85.4 72.7 84.9 100 85.3
1UHSRUWHG 198 11 66 10 285
Hypercholesterolemia (%) 80.3 54.6 75.8 80.0 78.3
1UHSRUWHG 198 11 66 10 285
Smoking (%) 25.8 36.4 60.6 0.0 33.3
1UHSRUWHG 198 11 66 10 285
CAD (%) 56.6 27.3 57.6 30.0 54.7
1UHSRUWHG 198 11 66 10 285
DM (%) 38.9 0.00 50.0 30.0 39.7
1UHSRUWHG 198 11 66 10 285
Rutherford Category of Target Limb
1UHSRUWHG 198 11 15 10 219
Class 1 (%) 3.5 0 0 3.2
Class 2 (%) 40.4 45.5 10.0 39.3
Class 3 (%) 56.1 36.4 60.0 55.3
Class 4 (%) 0.0 0 0 0
Class 5 (%) 0.0 18.2 30.0 2.3
Indication of Target Limb
1UHSRUWHG 198 11 71 10 290
Claudication (%) 100 90.9 49.3 70.0 86.6
Critical Limb Ischemia (%) 0 9.1 50.7 30.0 13.4
ABI of Target Limb
1UHSRUWHG 183 15 51 10 244
Mean 0.72 0.61 0.41 0.69
St Dev 0.20 0.22 0.18 0.22
Range 0.24 - 1.45 0 - 1.34 0.1 - 0.67 0 – 1.45

2QHSDWLHQWGLGQRWUHSRUWJHQGHU
151RW5HSRUWHG

11
 Lesion and Stent Characteristics*
Characteristic RESILIENT ELODIE I US Series EU Series TOTAL
13DWLHQWV 198 11 66 10 285
17UHDWHG/LPEV 198 11 72 10 291
17UHDWHG/HVLRQV 212 16 72 10 310
Individual Lesion Length
1UHSRUWHG 212 16 72 10 310
Mean (mm) 66.0 108.8 152.6 214.0 93.1
St Dev Length 35.7 44.7 104.5 109.6 75.1
0HDQ1SHU/LPE 1.1 1.5 1.1 1.0 1.1
Percent Stenosis (max per limb):
1UHSRUWHG 198 11 0 10 219
Mean 87.8 92.7 96.0 88.5
St Dev 11.3 9.05 6.99 11.2
Range 50 - 100 80 - 100 80 - 100 50 - 100
17RWDO/HVLRQ/HQJWKV
PP 62 1 9 0 72
şPP 93 0 19 0 112
şPP 37 6 15 3 61
şPP 5 1 3 4 13
200 – 240 mm 1 2 8 0 11
ƊPP 0 1 18 3 22
Total Lesion Lengths:
1 198 11 72 10 291
Mean 70.6 158.2 152.6 214 99.15
St Dev 37.7 57.8 104.5 109.6 77.3
Range 10 - 202 30 - 240 16 - 360 140 - 500 10 - 500
17RWDO6WHQWHG/HQJWKV
PP 40 0 15 0 40
şPP 71 0 15 0 71
şPP 73 1 15 1 75
şPP 7 7 15 5 19
şPP 5 0 15 1 6
ƊPP 2 3 15 3 8
Total Stent Lengths:
1 198 11 15 10 219
Mean 104.5 204.5 244.4 115.9
St Dev 55.4 53.2 125.1 69.4
Range 30 - 340 160 - 290 160 - 574 30- 574
TASC Classification
1*UDGH$  1 (9.1%) 23 (39.0%) 24 (34.3%)
1*UDGH%  15 3 (27.3%) 11(18.6 %) 15 14 (20.0%)
1*UDGH&  7 (63.6%) 6 (10.2%) 13 (18.6%)
1*UDGH'  0 (0%) 19 (32.2%) 19 (27.1%)
Total 11 59 70

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lesion characteristics reported by the core lab
151RW5HSRUWHG

12
Methods
6XEMHFWV UHFHLYHG DW OHDVW RQH FRPPHUFLDOO\ DYDLODEOH LIFESTENTŪ VWHQW  LQ WKH FDVH RI WKRVH VXEMHFWV HQUROOHG LQ WKH 5(6,/,(17 VWXG\
,'(* WKH\UHFHLYHGWKHGHYLFHDVGHVFULEHGLQ*ZKLFKZHUHLGHQWLFDOWRWKHFXUUHQWFRPPHUFLDOO\DYDLODEOHLIFESTENT®
device. Specifically, the following analyses were undertaken:

š (VWLPDWLQJWKHSDWHQF\ GHıQHGLQWKLVDQDO\VLVDVIUHHGRPIURP795 DWPRQWKVSRVWSURFHGXUHRIOHVLRQVRIOHQJWKPPPP

PPDQGPP ORQJWHUPHijHFWLYHQHVV
š &RPSDULQJWKHDFXWHVDIHW\SHUIRUPDQFHRIWKHLIFESTENTŪGHYLFHDWGD\VSRVWSURFHGXUHWRWKH9L9D23&DQG
š (VWLPDWLQJWKHIUHHGRPIURPGHDWKDQGDPSXWDWLRQDWPRQWKVSRVWSURFHGXUHLQSDWLHQWVZLWKORQJOHVLRQVWUHDWHGZLWKWKHLIFESTENT®
device by calculating the observed rates in this study (long-term safety).

Data for this retrospective analysis were compiled ‚as received‘ from their respective sources.

Results
The rate of freedom from death, amputation, and TVR, at 30 days post-procedure was 99.6% for the combined performance of the LIFESTENT®
and LIFESTENT® ;/ 9DVFXODU 6WHQW 6\VWHPV DQG  IRU WKH 9,9$ 23& )XUWKHUPRUH ORQJWHUP VDIHW\ ZDV VKRZQ WR KDYH D FOLQLFDOO\
DFFHSWDEOHIUHHGRPIURPGHDWKDQGDPSXWDWLRQUDWHWKURXJKPRQWKV  0RUHRYHUHijHFWLYHQHVVZDVHYDOXDWHGWKURXJKHVWLPDWLRQ
of patency at 12 months post-procedure for lesion lengths of 50 mm, 100 mm, 160 mm, 200 mm and 240 mm via the lesion-length model.
The patency at 12 months for lesions greater than 160 mm in length is 67%.

e. REALITY STUDY

Design
7KH 5($/,7< VWXG\ ZDV D VLQJOHDUP QRQUDQGRPL]HG SURVSHFWLYH VLQJOH FHQWHU VWXG\ WR DVVHVV WKH GHOLYHUDELOLW\ FOLQLFDO XWLOLW\ DQG
HijHFWLYHQHVV RI WKH b PP GLDPHWHU VL]H RijHULQJ RI WKH LIFESTENT® 9DVFXODU 6WHQW 6\VWHP LQ VXEMHFWV ZLWK OLIHVW\OHOLPLWLQJ FODXGLFDWLRQ
or minor tissue loss (Rutherford Category 2 - 5) who were candidates for PTA and stenting with lesion(s) in the infra-inguinal segment
6)$DQGRUSRSOLWHDODUWHU\ $WRWDORIVXEMHFWVZHUHWUHDWHGDW(XURSHDQLQYHVWLJDWLYHVLWH
6XEMHFWVHOLJLEOHWREHHQUROOHGLQWKLVVWXG\KDGWREH5XWKHUIRUG&DWHJRU\7KHWDUJHWYHVVHOUHIHUHQFHGLDPHWHUZDV E\YLVXDOHVWLPDWH 
DSSURSULDWH IRU WUHDWPHQW ZLWK DYDLODEOH VWHQW GLDPHWHU RI  PP 7KH UHIHUHQFH YHVVHO GLDPHWHU 59'  RI WKH WUHDWHG VXEMHFWV ZDV WR
PPLQGLDPHWHU6XEMHFWVZHUHIROORZHGDWGD\V

Demographics
&KDUDFWHULVWLFVRIWKHVXEMHFWVHQUROOHGLQWKHVWXG\LQFOXGLQJDJHJHQGHUPHGLFDOKLVWRU\DVZHOODVOHVLRQFKDUDFWHULVWLFVDUHSURYLGHGLQ
the tables below.

Subject Demographics
Variable Category Total

Mean 69
Age at Procedure (yrs)
Standard Deviation 10.5

Female 60.0 (18/30)

*HQGHU Q1
Male 40.0 (12/30)

Caucasion 96.7 (29/30)

5DFH Q1
Asian 3.3 (1/30)

Hyperlipidemia ~57%

Hypercholesteremia ~87%

Diabetes ~37%

13
 Lesion Characteristics
Variable Category Total

1XPEHURI/HVLRQV 1 30/32
2 2/32
Left 62.5%
Target Side
Right 37.5%
Lesion Length (mm) Mean, Standard deviation 64.8, 50.0
Target Vessel (RVD) Mean, Standard Deviation 4.5, 0.2
Stenosed 68.8%
Lesion Classification 2FFOXGHG 28.1%
5H2FFOXGHG 3.1%
TASC A 43.8%
TASC B 34.4%
Lesion Severity/TASC Grade
TASC C 15.6%
TASC D 6.3%
1R&DOFLıFDWLRQ 34.4%
Mild Calcification 21.9%
Lesion Calcification
Moderate Calcification 18.8%
Severe Calcification 25.0%

Methods
6XEMHFWVXQGHUZHQW37$SOXVLIFESTENT® Vascular Stent placement in the target lesion(s). All data were collected on case report forms at the
investigative site.

Results
The LIFESTENTŪ9DVFXODU6WHQW6\VWHPLVHijHFWLYHDVWHFKQLFDOVXFFHVVZDVVKRZQLHGHSOR\PHQWDFFXUDF\ZDVJRRGRUH[FHOOHQWDQG
placement accuracy was successful at target site. Additionally, freedom from TLR and/or TVR was achieved. The LIFESTENT® Vascular Stent is
safe in the acute period (index procedure through the 30-day follow-up period) as demonstrated through freedom from occurrence of death,
DPSXWDWLRQDQG7/5DQGRU7951R$'(VZHUHUHSRUWHGGXULQJWKLVSHULRG

f. ETAP RANDOMIZED PHYSICIAN-SPONSORED STUDY

Design
7KH(7$3*SK\VLFLDQVSRQVRUHGVWXG\ZDVFRQGXFWHGDWQLQH(XURSHDQFHQWHUVDVDSURVSHFWLYHUDQGRPL]HGFRQWUROOHGVWXG\WRLQYHVWLJDWH
the use of LIFESTENT® Vascular Stent Systems in patients with stenosis and occlusion of the popliteal artery in comparison to percutaneous
transluminal angioplasty (PTA) alone.
A total of 246 patients were recruited and randomized into the two treatment groups, PTA or stent. 119 patients were randomized to the stent
group and 127 patients were randomized to the PTA group. For patients randomized to the PTA group, a balloon angioplasty was performed,
representing standard clinical care of these lesions. If a lesion had a residual stenosis of > 50% after repeated and persistent (5 minutes)
LQIJDWLRQVRUDIJRZOLPLWLQJGLVVHFWLRQDSURYLVLRQDOVWHQWZDVXVHGWRWUHDWWKHOHVLRQ2IWKHSDWLHQWVUHFUXLWHGLQWKHVWXG\SDWLHQWV
received a LIFESTENT® device while 93 patients received PTA alone. Results are provided to individually show the results for the P1 segment
and P2/P3 segments in order to compare the outcomes.

*Rastan A, Krankenberg H, Baumgartner I, et al. Stent placement vs. balloon angioplasty for popliteal artery treatment: Two-year results of a
SURVSHFWLYHPXOWLFHQWHUUDQGRPL]HGWULDO-(QGRYDVF7KHU

14
 ETAP Trial Demographics
Characteristic (ITT population) 37$ 1  6WHQW 1  7RWDO 1 
Age (years) Median 73 72 72
Range 41 - 89 42 - 89 41 - 89
*HQGHU1 
Female 45 (35.4) 43 (36.1) 88 (35.8)
Male 82 (64.6) 76 (63.9) 158 (64.2)
5XWKHUIRUG&DWHJRU\1 
Category 1 3 (2.4) 4 (3.4) 7 (2.8)
Category 2 12 (9.4) 24 (20.2) 36 (14.8)
Category 3 76 (59.8) 68 (57.1) 144 (58.5)
Category 4 8 (6.3) 4 (3.4) 12 (4.9)
Category 5 22 (17.3) 16 (13.4) 38 (15.4)
Category 6 - 1 (0.8) 1 (0.4)
Missing 6 (4.7) 2 (1.7) 8 (3.3)
Hypertension (%) 112 (88.2) 98 (82.4) 210 (85.4)
Hypercholesterolemia (%) 104 (81.9) 90 (75.6) 194 (78.9)
Smoking (%) 29 (23) 26 (21.8) 55 (22.4)

ETAP Trial Lesion Characteristics

Variable (ITT Population) 37$ 1  6WHQW 1 
Mean Lesion Length (mm) 43.2 41.3
(STD) (28.1) (31.3)
Stenosis (%) 92.5 92.9
(STD) (7.9) (7.2)
Lesion Location, (% patients)
Popliteal I 37 (29.1) 35 (29.4)
Popliteal II 54 (42.5) 48 (40.3)
Popliteal III 6 (4.7) 7 (5.9)
Popliteal I + II 23 (18.1) 20 (16.8)
Popliteal II + III 6 (4.7) 7 (5.9)
Popliteal I + II + III 1 (0.8) 2 (1.7)
Lesion Calcification, (%, patients)
Missing 35 (27.6) 32 (26.9)
Unable to Determine 1 (0.8) -
1RQH 14 (11.0) 8 (6.7)
Little 21 (16.5) 33 (27.7)
Moderate 11 (8.7) 14 (11.8)
Severe 45 (35.4) 32 (26.9)

Methods
3DWLHQWVXQGHUZHQW37$RUVWHQWLQJDQGUHFHLYHGDFHW\OVDOLF\OLFDFLG $66LIQRWDOUHDG\RQORQJWHUPWUHDWPHQW DQGDGGLWLRQDOO\UHFHLYHG
clopidogrel before the intervention and for a minimum of 4 weeks after the intervention as long-term medication. Patients were followed for
24 months with scheduled visits after 6, 12, and 24 months.

15
Results
Patients in the stent group had a lower restenosis rate than patients in the PTA group, when the crossover procedure was considered to be
D7/5DQGE\GHıQLWLRQDUHVWHQRVLV$OVRDQDO\VLVRIVHFRQGDU\HQGSRLQWVVXJJHVWHGDEHQHıFLDOFOLQLFDOWUHQGLQIDYRURIVWHQWSODFHPHQW
however, conclusions regarding significance of individual endpoints may not be made. Provisional stent placement with a LIFESTENT® Stent
ZDVREVHUYHGGXULQJWKLVVWXG\LQRIWKHUDQGRPL]HG37$SRSXODWLRQ1RFRQFHUQLQJWUHQGVZHUHQRWHGUHJDUGLQJRYHUDOOVDIHW\ZKHQ
the LIFESTENT® Stent was compared to PTA for multiple safety endpoints.

J. Principal Safety and Effectiveness Tables

a. RESILIENT RANDOMIZED STUDY

RESILIENT Principal Safety and Effectiveness Table

Variable Test Control p-value
0$&(DW'D\V Q1 0.0 (0/134) 1.4 (1/72) ns*
)UHHGRPIURP0$&(DW0RQWKV 93.9 92.8 ns*
)UHHGRPIURP0$&(DW0RQWKV 86.6 85.1 ns*
)UHHGRPIURP0$&(DW0RQWKV 80.5 79.7 ns*
)UHHGRPIURP0$&(DW0RQWKV 75.2 75.2 ns*

/HVLRQ6XFFHVV Q1 95.8 (114/119) 83.9 (52/62) 0.009

+HPRG\QDPLF6XFFHVV Q1 71.2 (79/111) 59.6 (31/52) ns*

3URFHGXUH6XFFHVV Q1 95.8 (114/119) 83.9 (52/62) 0.009

&OLQLFDO6XFFHVVDW0RQWKV Q1 82.2 (97/118) 30.9 (21/68) 
Primary Patency at 6 Months, % 94.2 47.4 
Secondary Patency at 6 Months, % 100.0 98.3 ns*
Freedom From TVR/TLR at 6 Months, % 94.6 52.6 
&OLQLFDO6XFFHVVDW0RQWKV Q1 72.3 (81/112) 31.8 (21/66) 
Primary Patency at 12 Months, % 81.5 36.7 
Secondary Patency at 12 Months, % 100.0 98.3 ns*
Freedom From TVR/TLR at 12 Months, % 82.7 45.2 
&OLQLFDO6XFFHVVDWPRQWKV Q1 68.6 (70/102) 25.4 (16/63) 
Freedom From TVR/TLR at 24 months, % 70.5 40.1 
&OLQLFDO6XFFHVVDWPRQWKV Q1 63.2 (60/95) 17.9 (10/56) 
Freedom From TVR/TLR at 36 months, % 68.1 40.1 0.0002

ns* - not significant

Definitions (secondary endpoints denoted with an asterisk (*)):

0DMRUDGYHUVHFOLQLFDOHYHQWV  0$&(  Any event of death (through 30-days), stroke, myocardial infarction, significant distal embolization,
emergent surgical revascularization of target limb, thrombosis, and/or worsening Rutherford category post procedure at the indicated time
point.

Lesion Success*: Attainment of ≤ 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational
device.

Hemodynamic Success*: Angiographic evidence of improved flow across the treated area immediately post-procedure. ABI improved from
EDVHOLQHE\ƊDQGQRWGHWHULRUDWHGE\!

16
Procedure Success*: Attainment of ≤ 30% residual stenosis of the target lesion and no in-hospital serious adverse events defined as: death,
stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in the target limb, and thrombosis of the
target vessel.

Clinical Success*: Relief or improvement of baseline symptoms by Rutherford categories/grades for acute or chronic limb ischemia and the
“definition of improvement”. Improvement must be sustained by one clinical category above the pre-treatment clinical value.

Primary Patency*: The continued flow through the target lesion as evidenced by DUS or angiogram without further/repeat intervention over
time.

Secondary Patency*: The patency history for the target lesion that is sustained or restored (with repeated intervention) over time.

Target Vessel Revascularization (TVR) / Target Lesion Revascularization (TLR): Any “clinically-driven” repeat percutaneous intervention of the
WDUJHWOHVLRQRUE\SDVVVXUJHU\RIWKHWDUJHWYHVVHO,IDFRQWUROVXEMHFWUHTXLUHVDVWHQWSHULSURFHGXUDOO\GXHWRDEDLORXWSURFHGXUHLWZLOO
be considered a TLR/TVR for the control group.

Survival Analysis – Freedom from MACE (at 36 months)

Time Until MACE

RESILIENT MACE Event Rate

MACE Event Free Event Rate P-Value*
Test (LIFESTENT® Stent System) 75.2% 24.8%
0.98
Control (balloon angioplasty) 75.2% 24.8%
SYDOXHbLVbIURPb/RJUDQNbWHVWbRQbDOObDYDLODEOHbGDWD

17
Survival Analysis – Freedom from Loss of Primary Patency (at 12 months)

Time Until Loss of Primary Patency

RESILIENT Loss of Primary Patency Event Rate

Loss of Primary Patency Event Free Event Rate P-Value*
Test (LIFESTENT® Stent) 81.5% 18.5%

Control (balloon angioplasty) 36.7% 63.3%
SYDOXHbLVbIURPb/RJUDQNbWHVWbRQbDOObDYDLODEOHbGDWD

Stent Fracture Analysis

Independent Analysis
$VSUHVSHFLıHGLQWKH5(6,/,(17SURWRFRO$3DQGODWHUDO[UD\VZHUHWDNHQDWDQGPRQWKVSRVWSURFHGXUHDQGDQDO\]HGE\DQ
LQGHSHQGHQWFRUHODE;UD\VRQVWHQWVZHUHDYDLODEOHIRUDQDO\VLVIURPDOOSKDVHVRIWKH5(6,/,(17WULDO)UDFWXUHVZHUHFODVVLıHGDV
follows:

Classification Type
1 Single-strut fracture only
2 0XOWLSOHVLQJOHVWHQWIUDFWXUHVRFFXULQJDWGLijHUHQWVLWHV
3 Multiple stent fractures resulting in complete transverse linear fracture but without stent displacement
4 Complete transverse linear fracture with stent displacement
%DVHGRQ$OOLHHWDOHQGRYDVFXODUWRGD\-XO\$XJXVW

18
* Please note that the fracture analysis in the RESILIENT Study was conducted by an independent core laboratory using the classification
system described by Allie et al., 2004 in accordance with the protocol approved in the IDE prior to study initiation (G040023, 3/19/2004).
This system classifies fractures into four distinct types. Since study initiation, other stent classification systems have been proposed
(Scheinert et al, 2005; Roca-Singh et al., 2007; Popma et al., 2009). The classification system published by Rocha-Singh et al., is currently
used by many core labs in the US, and splits the Type 4 fractures as defined by Allie et al. into “stent fracture(s) with mal-alignment of
components”(Type 4) and “stent fracture(s) in a trans-axial spiral configuration” (Type 5). The Type 4 fractures in the RESILIENT Study were
not sub-categorized according to the system proposed by Rocha-Singh and colleagues.

2QH  IUDFWXUHZDVQRWHGDWWKHWLPHRIWKHVL[PRQWKDQDO\VLVHLJKW  DGGLWLRQDOIUDFWXUHVZHUHQRWHGDWWKHWZHOYHPRQWKDQDO\VLV LH

between 6 and 12 months), and three (3) more fractures were noted at the final eighteen-month analysis (i.e., between 12 and 18 months).
67% (8/12) of the fractures were identified within 7 months of implantation. At the eighteen month analysis, six fractures were noted as Type
I (single-strut fracture) and six fractures were classified as Type IV (complete transverse fracture). Since the overall number of stent fractures
ZDVORZWKURXJKRXWWKHFRXUVHRIWKH5(6,/,(17WULDOVWDWLVWLFDODQDO\VLVDVWRFDXVHZDVQRWSRVVLEOH
It was observed however, that of the six Type IV fractures, all six were elongated at deployment, four of six occurred in lesions that were
moderate to severely calcified, and four of six occurred proximal or distal to an area of stent overlap. 38% of patients with >10% elongation
ZHQWRQWRGHYHORS7\SHIUDFWXUHVLQOHVVWKDQ\HDUDQGRIWKHIUDFWXUHVRFFXUUHGLQSDWLHQWVZKHUHPXOWLSOH Ɗ VWHQWVZHUH
GHSOR\HGLQDQRYHUODSSLQJIDVKLRQ1RSDWLHQWVZLWKVWHQWIUDFWXUHVGHYHORSHGUHVWHQRVLVDVHYDOXDWHGDWWKHPRQWKIROORZXSDQGQR
IUDFWXUHVZHUHDVVRFLDWHGZLWK0$&(2YHUDOOIUDFWXUHVLQ5(6,/,(17KDGQRDSSDUHQWHijHFWRQGHYLFHVDIHW\RUHijHFWLYHQHVV7KHIROORZLQJ
table summarizes the fractures categorized according to Allie, et. al.

RESILIENT Fracture Analysis (18 Months)

Type Count (stents/subjects)
Type 1 6/6
Type 4 5/4
Type 1 & 4 1/1
Total 12/11

Review of Medical Device Reporting

Since February 13, 2009, in the global commercial experience, Bard Peripheral Vascular received complaints of suspected LIFESTENT® Stent
IUDFWXUHV LQ  SDWLHQWV 2I WKHVH UHSRUWV QLQH   SDWLHQWV ZLWK  IUDFWXUHV ZHUH FRQıUPHG IURP HYDOXDWLRQ RI EDVHOLQH RU IROORZXS
angiograms. A review of the confirmed fractures showed that seven (7) of the stents had single strut fractures and three (3) of the stents
had multiple strut fractures. These were associated with one case of stent twisting, one case of stent elongation, and three cases of stent
compression that may have contributed to the occurrence of fracture. Classification of fracture type was not completed due to the limitations
of the data received from the user and a systematic review of all stents by an angiographic core lab was not performed. Because of the
GLĴFXOW\LQLGHQWLI\LQJVWHQWIUDFWXUHDQGWKHODFNRIFRPSUHKHQVLYHDQJLRJUDSKLFIROORZXSLWLVQRWSRVVLEOHWRGHWHUPLQHWKHWUXHIUDFWXUH
rate of the LIFESTENT® Stent in commercial use.

Conclusion
6WHQWIUDFWXUHVZHUHQRWHGWREHDQXQFRPPRQHYHQWLQWKH5(6,/,(17WULDODQGDSSHDUHGWRQRWLPSDFWWKHVDIHW\DQGSHUIRUPDQFHRIWKH
LIFESTENTŪLPSODQW6WHQWIUDFWXUHVPD\RFFXUZLWKWKHXVHRIRYHUODSSLQJVWHQWVKRZHYHUWKHUHZDVQRFRUUHODWLRQEHWZHHQVWHQWIUDFWXUHV
DQGWKHQXPEHURIVWHQWVLPSODQWHGLQWKH5(6,/,(17WULDO)UDFWXUHVPD\RFFXULQ6)$RUSRSOLWHDOVHJPHQWVWKDWXQGHUJRVLJQLıFDQWPRWLRQ
SDUWLFXODUO\LQDUHDVZLWKVHYHUHDQJXODWLRQDQGWRUWXRVLW\7KH5(6,/,(17WULDOZDVQRWGHVLJQHGWRVKRZDFRUUHODWLRQEHWZHHQVWHQWIUDFWXUHV
and the location, although six (6) fractured stents were observed in areas with severe calcification, and one (1) stent placed across the point
of flexion in the mid-popliteal region resulted in a fracture.

Patency vs. Lesion Length

In order to assess the impact of lesion length on patency outcomes, a Cox regression analysis, with the total lesion length as a risk factor
was performed which demonstrated that for the LIFESTENT® group, lesion length is not a significant predictor of primary patency outcomes
SYDOXH  $GGLWLRQDOO\WKHFDOFXODWHGKD]DUGUDWLRRILQGLFDWHVWKDWWKHUHLVRQO\DUHPRWHUHODWLRQVKLSEHWZHHQOHVLRQOHQJWK
and patency outcomes in the LIFESTENT® group. It should be noted that based on the analysis, the lesion length is a significant predictor of
SDWHQF\RXWFRPHVIRUWKHFRQWUROJURXS SYDOXH  

19
b. E-TAGIUSS CONFIRMATORY STUDY

E-TAGIUSS Principal Safety and Effectiveness Table

Variable Test % (n/N)
Death at 30 Days 0% (0/37)
0$&(DW'D\V 2.7% (1/37)
Deployment Success 100.0 (46/46)
Lesion Success 90.9 (30/33)
Procedure Success 90.9 (30/33)

Definitions (secondary endpoints denoted with an asterisk (*)):

0DMRU DGYHUVH FOLQLFDO HYHQWV  0$&(  Any event of death, stroke, myocardial infarction, emergent surgical revascularization, significant
distal embolization in the target limb, amputation of the target limb and thrombosis of the target vessel at the indicated time point.

Deployment Success: Ability to deliver the stent to the intended site with the post deployment stent length being within 10% of the pre-
deployment length.

Lesion Success*: Attainment of ≤ 30% residual stenosis of the target lesion using any percutaneous method and/or non-investigational device.

Procedure Success*: Attainment of ≤ 30% residual stenosis of the target lesion and no in-hospital serious adverse events defined as: death,
stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in the target limb, and thrombosis of the
target vessel.

c. RETROSPECTIVE ANALYSIS OF LIFESTENT® VASCULAR STENT SYSTEMS IN THE TREATMENT OF LONG-SEGMENT LESIONS

7KHUHVXOWVIRUWKHSULPDU\HijHFWLYHQHVVHQGSRLQWDVGHıQHGE\IUHHGRPIURP7957/5DUHVKRZQLQWDEOHEHORZ

Freedom from TLR/TVR* by Time and Lesion Length

12 months Weidbull* / Kaplan-Meier 24 months Weidbull* / Kaplan-Meier
Variable
(n/N**at 12 months) (n/N**at 24 months)
$YHUDJHRIDOO WRWDO OHVLRQOHQJWKV PP 82.4% / 79.2% (54/291) 63.3% / 62.5% (29/170)
Q  PPOHVLRQV :HLEXOOPP 85.4% / 83.4 (11/72) 69.0% / 68.1% (7/48)
Q  PPOHVLRQV :HLEXOOPP 81.9% / 87.9% (12/112) 62.5% / 74.3% (9/73)
Q  PPOHVLRQV :HLEXOOPP 76.7% / 76.5% (13/61) 53.6% / 55.2% (9/35)
Q  PPOHVLRQV :HLEXOOPP 72.6% / 38.9% (7/13) 47.0% / 38.9% (0/2)
Q  PPOHVLRQV :HLEXOOPP 67.9% / 67.5% (3/11) 1$ 
Q  !PPOHVLRQV 1$  1$ 

)URPWKH:HLEXOOFRYDULDWHDGMXVWHGDQDO\VLV
1XPEHUVWDUWLQJWKH\HDU

The primary acute safety endpoint of the LIFESTENT® and LIFESTENT® XL Vascular Stent Systems at 30 days post-procedure showed the freedom
IURPUDWHVZHUHKLJKHUWKDQWKH9L9D23&  7KHGD\IUHHGRPIURPGHDWKDPSXWDWLRQDQG795UDWHZDVZLWKDVWDQGDUGHUURU
of 0.34% (95% CI: 97.59% - 99.95%).

The primary long-term safety endpoint was freedom from death/amputation. The Kaplan-Meier analysis showed that the freedom-from-
GHDWKDPSXWDWLRQUDWHDWPRQWKVZDV OHVLRQVPP  OHVLRQVPP  OHVLRQVPP 
(lesions 160 - 200 mm), 90.9% (lesions 200 - 240 mm) and 94.1% (lesions >240 mm).

20
 Freedom from Death/Amputation*
12 months (n/N**)
All Lesions 93.8 (17/291)
/HVLRQVbPP 100% (0/72)
/HVLRQVbPP 94.5% (6/112)
/HVLRQVbPP 91.4% (5/61)
/HVLRQVbPP 63.6% (4/13)
/HVLRQVbPP 90.9% (1/11)
/HVLRQV!bPP 94.1% (1/22)

* From the Kaplan-Meier analysis

1XPEHUVWDUWLQJWKH\HDU

d. REALITY STUDY

7KHVDIHW\DQGHijHFWLYHQHVVUHVXOWVDUHVKRZQEHORZ

Technical Success: All 36 stents deployed in the study were successfully deployed.

Placement Accuracy: The deployment accuracy was evaluated and found to be acceptable in all cases.

Freedom from Death through 30 days post index procedure:$OOVXEMHFWVVKRZHGIUHHGRPIURPRFFXUUHQFHRIGHDWK

Freedom from Amputation through 30 days post index procedure:$OOVXEMHFWVVKRZHGIUHHGRPIURPRFFXUUHQFHRIDPSXWDWLRQ

Freedom from TLR/TVR through 30 days post index procedure:$OOVXEMHFWVVKRZHGIUHHGRPIURP7/5DQGRU795

3ULPDU\(ijHFWLYHQHVV(QGSRLQW Technical success, defined as successful deployment and placement accuracy based upon a rating scale
completed by the Investigators at the time of the index procedure. Bookend sizes were evaluated for clinical utility of size range.
All stents had good or excellent deployment accuracy with successful placement at the target site. In none of the patients, TLR and/or TVR
was conducted until day 30 from the index procedure.

3ULPDU\6DIHW\(QGSRLQW)UHHGRPIURPRFFXUUHQFHRIGHDWKDPSXWDWLRQDQG795DQGRU7/5DWbGD\VSRVWLQGH[SURFHGXUH
$OOVXEMHFWVVKRZHGIUHHGRPIURPRFFXUUHQFHRIGHDWKDPSXWDWLRQDQG7/5DQGRU795DWGD\SRVWLQGH[SURFHGXUH2YHUDOOWKLV
study demonstrated the safety of the LIFESTENT® Vascular Stent Systems deploying stents of 5 mm in diameter.

e. ETAP RANDOMIZED PHYSICIAN-SPONSORED STUDY

Restenosis 12 and 24 Months – PVR > 2.4

P1 P2/P3

Number (%) pts Number (%) pts

PTA (N=37) Stent (N=35) PTA (N=90) Stent (N=84)

12 mon 17 (53.1%) 12 (40.0%) 42 (56.0%) 19 (29.2%)
(YDOXDEOH6XEMHFWV 32 30 75 65
24 mon 15 (57.7%) 10 (43.5%) 42 (72.4%) 16 (32.0%)
(YDOXDEOH6XEMHFWV 26 23 58 50

This data collection was using ultrasound PVR>2.4

*evaluable accounts for missing data

21
Freedom from Restenosis for Popliteal Segment 1
Survival Distribution Function

LifeStent

PTA

7LPHIURP3URFHGXUHWRUHVWHQRVLV 395SUR[LPDOFXWRij XVLQJW\SHRIGHDOLQJZLWKFURVVRYHUSDWLHQW GD\V >FDOF@

STRATA treatran-PTA Censored treatran-PTA treatran-Stent Censored treatran-Stent

Control PTA Test Stent

Survival Subjects Censored Subjects Survival Subjects Censored Subjects
Time
%[95% CI] with Event Subjects at Risk %[95% CI] with Event Subjects at Risk
72.8% 93.8%
180 days 10 2 25 2 3 30
[65.4, 80.1] [89.5, 98.0]
43.7% 68.8%
365 days 20 4 13 10 4 21
[35.3, 52.1] [60.6, 76.9]
43.7% 51.4%
730 days 20 11 6 15 11 9
[45.3, 61.3] [42.3, 60.5]

Freedom from Restenosis for Popliteal P2/P3

LifeStent
Survival Distribution Function

PTA

7LPHIURP3URFHGXUHWRUHVWHQRVLV 395SUR[LPDOFXWRij XVLQJW\SHRIGHDOLQJZLWKFURVVRYHUSDWLHQW GD\V >FDOF@

STRATA treatran-PTA Censored treatran-PTA treatran-Stent Censored treatran-Stent

22
 Control PTA Test Stent
Survival Subjects Censored Subjects Survival Subjects Censored Subjects
Time
%[95% CI] with Event Subjects at Risk %[95% CI] with Event Subjects at Risk
70.8% 94.7%
180 days 26 6 58 4 9 71
[66.0, 75.6] [92.1, 97.3]
46.5% 75.8%
365 days 45 17 28 18 19 47
[40.9, 52.0] [70.8, 80.7]
39.8% 67.0%
730 days 48 33 9 23 39 22
[33.8, 45.8] [61.3, 72.8]

Safety
7KLUWHHQ  SDWLHQWVKDGGLHGE\0RQWKSDWLHQWVZKRZHUHWUHDWHGZLWK37$DQGSDWLHQWVZKRUHFHLYHGDVWHQW1RQHRIWKHDGYHUVH
events causing death were related to LIFESTENT® Stent or procedure.

Stent Fracture Analysis

7KHVWHQWIUDFWXUHUDWHZDVDVVHVVHGIRUSDWLHQWVZKRDFWXDOO\UHFHLYHGVWHQWWUHDWPHQW 75VHW1  $W0RQWKYDOLG[UD\GDWDZHUH
DYDLODEOHIRUSDWLHQWVZLWKVWHQWV SDWLHQWVZLWKRQHVWHQWDQGSDWLHQWVZLWKWZRVWHQWV )RXUSDWLHQWVKDGDVWHQWIUDFWXUH2IWKH
seven patients with two stents, none had a stent fracture in both stents.

The reported fracture rate was 5.4% at 12-months and 11.1% at 24-months for P2/P3 segment treatment. The number of available x-rays
was 37 and 45 x-rays at the 12-month and 24-month time-point respectively (see Table "X-ray Reported Stent Fractures"). Fractures are
counted once, at the first time the fracture was reported.

'XULQJWKH(7$3VWXG\SDWLHQWVLQWKH33JURXSH[SHULHQFHGWKUHH7\SH,RQH7\SH,,RQH7\SH,,,DQGWZR7\SH,9IUDFWXUHVZKLOH
WKH3JURXSKDGRQH7\SH,,,DQGRQH7\SH,,IUDFWXUH1RFRUUHODWLRQFRXOGEHIRXQGEHWZHHQWKHLQFLGHQFHRIVWHQWIUDFWXUHVDQGHLWKHU
restenosis or TLR.

X-ray Reported Stent Fractures

Stent Fractures*
X-ray(s) Reviewed
(%)
3 1  33 1  P1 P2/P3
12-month 23 37 2 (8.6%) 2 (5.4%)
24-month 25 45 0 5 (11.1%)

*Fractures were recorded the first time they were reported.

K. Patient Selection and Treatment

3DWLHQWVHOHFWLRQVVKRXOGEHEDVHGRQWKHSRSXODWLRQVWUHDWHGLQWKH5(6,/,(17(7$*,8665($/,7<DQG(7$3LQYHVWLJDWLRQV'HPRJUDSKLFV
for these investigations are provided in Section I – Clinical Investigations of this “Instructions for Use” document. Additionally, treatment of
the patients should follow the treatment practices used by the investigators of these studies. These methods have been reiterated below in
Section L – Patient Counseling Information and6HFWLRQ1ş,QVWUXFWLRQVIRU8VH.

L. Patient Counseling Information

Physicians should consider the following in counseling the patient about this product:
š 'LVFXVVWKHULVNVDVVRFLDWHGZLWKVWHQWSODFHPHQW
š 'LVFXVVWKHULVNVDVVRFLDWHGZLWKD LIFESTENT® implant.
š 'LVFXVVWKHULVNVEHQHıWVLVVXHVIRUWKLVSDUWLFXODUSDWLHQW
š 'LVFXVVDOWHUDWLRQVWRFXUUHQWOLIHVW\OHLPPHGLDWHO\IROORZLQJWKHSURFHGXUHDQGRYHUWKHORQJWHUP
š 'LVFXVVWKHULVNVRIHDUO\GLVFRQWLQXDWLRQDQWLSODWHOHWWKHUDS\

The following information is provided in the packaging for the physician to provide their patients:
š $3DWLHQW*XLGHZKLFKLQFOXGHVLQIRUPDWLRQRQWKHLIFESTENT® Vascular Stent System, peripheral artery occlusive disease, the implantation
procedure and patient care following the implant.
š $3DWLHQW,PSODQW&DUGWKDWLVXVHGWRUHFRUGDQGGLVVHPLQDWHLQIRUPDWLRQDERXWWKHSDWLHQWDQGWKHVWHQW

23
M. How Supplied
STERILE:)256,1*/(86(21/<7KHLIFESTENT® Vascular Stent System is supplied sterile (by ethylene oxide gas) and is nonpyrogenic. Do
not resterilize and/or reuse the device. Do not use if the temperature exposure indicator (i.e., square label found on the pouch) is black as
the unconstrained stent diameter may have been compromised. The temperature exposure indicator label should be grey and must be clearly
visible on the pouch. Do not use if pouch is opened or damaged. Do not use the device after the “Use By” date specified on the label. For
returned product or product issues, please contact Bard Peripheral Vascular at the address below:
Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, AZ 85281 USA
CONTENTS for one (1) LIFESTENT® Vascular Stent System:
š 2QH  LIFESTENT® Vascular Stent System
š 2QH  3DWLHQW,PSODQW&DUG
š 2QH  ,QVWUXFWLRQVIRU8VH
š 2QH  3DWLHQW*XLGH
STORAGE: Store in a cool, dark, dry place. Storage temperature should not exceed 60 °C. Use by the “Use By” date specified on the label.
DISPOSAL INSTRUCTIONS: After use, dispose of product and packaging in accordance with hospital, administrative and/or local government
policy.

N. Instructions for Use

Pre-Deployment Procedure

1. Inject Contrast Media

Perform an angiogram using standard technique.

2. Evaluate and Mark Target Site

Fluoroscopically evaluate and mark the target site, observing the most distal diseased or obstructed segment.

3. Select Stent Size

 0HDVXUHWKHOHQJWKRIWKHWDUJHWOHVLRQWRLGHQWLI\WKHDSSURSULDWHOHQJWKRIVWHQW V UHTXLUHG(QVXUHWKDWWKHVWHQWLVORQJHQRXJKWRSHUPLW
the area proximal and distal of the lesion to be covered by the stent.
Identify the diameter of the reference vessel (proximal and distal to the lesion). To ensure secure placement, refer to the stent size
selection table for proper sizing scheme.

Stent Size Selection Table: LIFESTENT® Vascular Stent System

Reference Vessel Diameter Unconstrained Stent Inner Diameter
4.0 – 4.5 mm 5.0 mm
4.0 – 5.5 mm 6.0 mm
5.6 – 6.5 mm 7.0 mm
Refer to product labeling for stent length
4. Materials Required
In addition to the LIFESTENT® Vascular Stent System, the following standard materials may also be required to facilitate delivery and
deployment of the LIFESTENT® Vascular Stent System: heparinized normal saline, 6F (2.0 mm) or larger introducer sheath, 0.035” diameter
guidewire, standard balloon angioplasty (PTA) catheter, contrast medium diluted 1:1 with heparinized normal saline, inflation device and
appropriate anticoagulation and antiplatelet drugs.

5. Prepare Stent System

D  2SHQWKHER[DQGUHPRYHWKHSRXFKFRQWDLQLQJWKHVWHQWV\VWHP
b) Check the temperature exposure indicator label on the pouch to confirm that the grey background is clearly visible. See “Warnings” section.
c) Carefully inspect the pouch for damage to the sterile barrier. Do not use after the expiration date. Peel open the pouch and remove the
WUD\FRQWDLQLQJWKHVWHQWV\VWHP([WUDFWWKHVWHQWV\VWHPIURPWKHWUD\DQGFKHFNWKHIROORZLQJ
i) Verify that the shipping lock is still secure in the stent system handle.
 LL  ([DPLQHWKHVWHQWV\VWHPIRUDQ\GDPDJH,ILWLVVXVSHFWHGWKDWWKHVWHULOLW\RUSHUIRUPDQFHRIWKHVWHQWV\VWHPKDVEHHQFRPSURPLVHG
the device should not be used.

24
d) Visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath. Do not use if the stent is partially
deployed.
e) Visually inspect the distal end of the delivery system catheter to ensure there is no gap between the delivery system catheter tip (grey
colored) and the primary sheath (braided catheter with light blue colored end) such that the guidewire lumen (orange colored) is visible.
Do not use the device if the orange colored guidewire lumen is visible.
f) Flush the inner lumen of the stent system with heparinized normal saline prior to use.
g) Wipe the usable length portion of the stent system with gauze soaked with heparinized normal saline.

Stent Deployment Procedure

1. Insert Introducer Sheath and Guidewire
a) Gain femoral access at the appropriate site using a 6F (2.0 mm) or larger introducer sheath.
b) Insert a 0.035" diameter guidewire of appropriate length (see table) across the lesion to be stented via the introducer sheath.

Recommended Guidewire Length Table

Catheter Working Length Recommended Guidewire Length
130 cm 300 cm
80 cm 260 cm

It is recommended to use the 80 cm working length device for ipsilateral procedures. The longer working length of the 130 cm device
may potentially be challenging for the user to keep straight for ipsilateral procedures. Failure to keep the device straight may impede the
optimal deployment of the implant.
2. Dilate Lesion
Predilation of the lesion should be performed using standard techniques. While maintaining site access with a guidewire, remove the
balloon catheter from the patient.
Caution: During dilation, do not expand the balloon such that dissection complication or perforation could occur.

3. Introduce stent system

a) Advance the stent system over the 0.035" diameter guidewire through the sheath introducer. Always use for contralateral access the stent
V\VWHPLQFRQMXQFWLRQZLWKDORQJLQWURGXFHUVKHDWKZKLFKFRYHUVWKHDRUWLFELIXUFDWLRQ
Note: If resistance is met during stent system introduction, the stent system should be removed and another stent system should
be used.
Caution: Always use an introducer sheath for the implant procedure to protect the vasculature and the puncture site. A 6F (2.0 mm)
or larger introducer sheath is recommended.
b) Position the tip of the stent system past the target site.
c) Pull back the stent system until the distal and proximal stent radiopaque markers are in position so that they are distal and proximal to
the target site.
d) Remove slack from the stent system held outside the patient.

Caution: Any slack in the stent system (outside the patient) could result in deploying the stent beyond the target site.

4. Deploy stent
a) Verify that the distal and proximal stent radiopaque markers are distal and proximal to the target lesion.
b) Confirm that the introducer sheath is secure and will not move during deployment.
c) Remove the shipping lock.

25
d) To ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.
Note:'R127KROGWKHVLOYHUVWHQWGHOLYHU\VKHDWKDWDQ\WLPHGXULQJGHSOR\PHQW'2127FRQVWULFWWKHVWHQWGHOLYHU\VKHDWKGXULQJVWHQW
deployment.

e) Initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position.
Note: If excessive force is felt during stent deployment, do not force the stent system. Remove the stent system as possible, and replace
with a new unit.
f) While using fluoroscopy, maintain position of the distal and proximal stent radiopaque markers relative to the targeted site. Watch for the
GLVWDOVWHQWUDGLRSDTXHPDUNHUVWREHJLQVHSDUDWLQJVHSDUDWLRQRIWKHGLVWDOVWHQWUDGLRSDTXHPDUNHUVVLJQDOVWKDWWKHVWHQWLVGHSOR\LQJ
Continue turning the thumbwheel until the distal end of the stent obtains complete wall apposition.
g) With distal end of the stent apposing the vessel wall, final deployment can be continued with the following methods (Fig. 3, 4, 5).

Continue to rotate the thumbwheel

to achieve complete stent
deployment.

Figure 3. Thumbwheel

While maintaining a fixed handle position,

place your finger in front of the
deployment slide and slide it
from the distal to proximal end.

Figure 4. Fast Track Deployment Lever

While maintaining a fixed handle position, peel the

circular ring from the handle. Pull
the rapid deployment ring
towards the proximal end of the
handle to achieve complete
stent deployment.

Figure 5. Rapid Deployment Ring

h) Deployment of the stent is complete when the proximal stent radiopaque markers appose the vessel wall and the sheath radiopaque zone
is proximal to the proximal stent radiopaque markers.
i) DO NOT attempt to re-sheath stent system prior to removal.

5. Post stent placement

a) Remove the stent system from the body.
Note: If resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.
b) Post stent expansion with a PTA catheter is recommended. If performed, select a balloon catheter that matches the size of the reference
vessel, but that is not larger than the stent diameter itself.
c) Remove the guidewire and introducer sheath from the body.
d) Close entry wound as appropriate.
e) Discard the stent system, guidewire, and introducer sheath.
Note: Physician experience and discretion will determine the appropriate drug regimen for each patient.

26
Symbols used on labeling DISCLAIMER OF WARRANTY
BARD PERIPHERAL VASCULAR, INC. WARRANTS
TO THE FIRST PURCHASER OF THIS PRODUCT,
Keep away from sunlight
THAT THIS PRODUCT WILL BE FREE FROM
DEFECTS IN MATERIALS AND WORKMANSHIP
FOR A PERIOD OF ONE YEAR FROM THE DATE
OF FIRST PURCHASE AND LIABILITY UNDER THIS
Keep dry
LIMITED PRODUCT WARRANTY WILL BE LIMITED,
TO REPAIR OR REPLACEMENT OF THE DEFECTIVE
PRODUCT, IN BARD‘S SOLE DISCRETION,
The Green Dot OR REFUNDING YOUR NET PRICE PAID. WEAR
AND TEAR FROM NORMAL USE OR DEFECTS
RESULTING FROM MISUSE OF THIS PRODUCT IS
NOT COVERED BY THIS LIMITED WARRANTY.
Recyclable TO THE EXTENT ALLOWABLE BY APPLICABLE LAW,
THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF
ALL OTHER WARRANTIES, WHETHER EXPRESS
OR IMPLIED, INCLUDING, BUT NOT LIMITED TO,
MR Conditional ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. IN
NO EVENT WILL BARD PERIPHERAL VASCULAR,
INC. BE LIABLE TO YOU FOR ANY INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES
RESULTING FROM YOUR HANDLING OR USE OF
THIS PRODUCT.
Some countries do not allow an exclusion of implied
warranties, incidental or consequential damages.
<RXPD\EHHQWLWOHGWRDGGLWLRQDOUHPHGLHVXQGHUWKH
laws of your country.

27
 LIFESTENT® Vascular Stent Systems

Bard and LifeStent are trademarks and/or registered trademarks of C. R. Bard, Inc.

All other trademarks are the property of their respective owners.

Caution: Federal (USA) law restricts this device to sale by or on order of a physician.

Copyright © 2016 C. R. Bard, Inc.

All Rights Reserved.

Distributed by: Manufactured by:

Bard Peripheral Vascular, Inc. Angiomed GmbH & Co.

1625 West 3rd Street Medizintechnik KG
Tempe, AZ 85281 Wachhausstrasse 6
USA 76227 Karlsruhe
7(/  Germany
1-800-321-4254
FAX: 1-480-966-7062
1-800-440-5376
www.bardpv.com

B05678 Rev.2/04-16

28