Clinically Proven Stent Design:

As the only commercially available stent FDA-approved for the superficial femoral and full popliteal artery, the LifeStent™ Vascular Stent has a history of proven performance:

• In a Level 1 RESILIENT study, the LifeStent™ Vascular Stent demonstrated treatment superiority over balloon angioplasty with sustained effectiveness out to 3 years
• In the investigator initiated, Level 1 ETAP study of the popliteal artery the LifeStent™ Vascular Stent demonstrated double the primary patency rate of PTA out to two years
• In a clinical assessment of the treatment of long lesions, the LifeStent™ Vascular Stent demonstrated high primary patency at 12 months in lesions up to 240mm

The LifeStent™ Vascular Stent Systems, in varying sizes, have been studied in more than ten clinical trials globally.

Low Profile, 5F Delivery System:

The LifeStent™ 5F Vascular Stent System offers the same clinically-proven advanced helical stent design as the LifeStent™ Vascular Stent on a low profile, 5F delivery system. The LifeStent™ 5F delivery system offers dual speed thumbwheel deployment with a tri-axial catheter that is designed for ease of use, deployment control, and precise placement accuracy.

The LifeStent™ 5F Vascular Stent System is part of the Bard 5F ProSeries™ suite of low profile products designed to minimize arteriotomy size and enable physicians to complete a 5F procedure when treating the SFA and popliteal artery.

The LIFESTENT® 5F Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de novo or restenostic 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

CONTRAINDICATIONS

The LIFESTENT® 5F Vascular Stent System is contraindicated for use in:

• Patients with a known hypersensitivity to nitinol (nickel-titanium), and tantalum.

• Patients who cannot receive recommended anti-platelet and/or anti-coagulation therapy.

• Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system

PRECAUTIONS

• The device is intended for use by physicians who have received appropriate training.

• During system flushing, observe that saline exits at the catheter tip.

• The delivery system is not designed for use with power injection systems.

• Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.

• Keep the device as straight as possible following removal from the packaging and while inserted in the patient. Failure to do so may impede the optimal deployment of the implant.

• Prior to and during stent deployment, remove slack from the delivery system catheter outside the patient by gently holding the stability sheath and keeping it straight and under tension.

• If excessive force is felt during stent deployment, DO NOT force the delivery system. Remove the delivery system and replace with a new unit.

• Store in a cool, dark, dry place.

• DO NOT attempt to break, damage, or disrupt the stent after placement.

• Cases of fracture have been reported in clinical use of the LIFESTENT® 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).

• The safety and effectiveness of this device for use in treatment of in-stent restenosis has not been established.

• The GEOALIGN® Marking System is designed to be used as an additional reference tool to accompany the interventionalist‘s standard operation procedure. The use of fluoroscopic imaging is recommended following positioning of the catheter to the target lesion and prior to stent deployment or balloon inflation.

• If the GEOALIGN® location reference is on the brown moving sheath (Figure 9), the location reference will move relative to the introducer hub and stability sheath as soon as stent deployment has been initiated. DO NOT try to re-align the location reference after stent deployment has been initiated. The green stability sheath should remain stationary relative to the introducer and under tension throughout deployment.

• Guidewire compatibility and device performance have been evaluated clinically with 0.035 inch guidewires only. Compatibility with 0.014 inch guidewires is based on non-clinical testing only

Potential adverse events that may occur include, but are not limited to, the following:

• Allergic/anaphylactoid reaction

• Amputation

• Aneurysm

• Angina/coronary ischemia

• Arterial occlusion/thrombus, near the puncture site

• Arterial occlusion/thrombus, remote from puncture site

• Arterial occlusion/restenosis of the treated vessel

• Arteriovenous fistula

• Arrhythmia • Bypass Surgery

• Death related to procedure

• Death unrelated to procedure

• Embolization, arterial

• Embolization, stent

• Fever

• Hemorrhage/bleeding requiring a blood transfusion

• Hematoma bleed, remote site

• Hematoma bleed at needle, device path: nonvascular procedure

• Hematoma bleed, puncture site: vascular procedure

• Hypotension/hypertension

• Incorrect positioning of the stent requiring further stenting or surgery

• Intimal injury/dissection

• Ischemia/infarction of tissue/organ

• Liver failure

• Local infection

• Malposition (failure to deliver the stent to the intended site)

• Open surgical repair

• Pain

• Pancreatitis

• Pulmonary embolism/edema

• Pneumothorax

• Pseudoaneurysm

• Renal failure

• Respiratory arrest

• Restenosis

• Septicemia/bacteremia

• Stent fracture

• Stent migration

• Stroke

• Vasospasm

• Venous occlusion/thrombosis, remote from puncture site

• Venous occlusion/thrombosis, near the puncture site