• Longest lesion length indication (up to 240 mm)
• Proven performance in long lesions
• Designed for enhanced distal and proximal stent placement accuracy
• Treat longer lesions with one stent

LifeStent™ Solo™ Vascular Stent System is intended to improve lumina! 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.

Contraindications

The LIFESTENT. 5010TM Vascular Stent System is contraindicated for use in:

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

• Patients who cannot receive recommended antiplatelet 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. Note: An insignificant amount may also exit at the junction between the stent delivery sheath and the system stability sheath.

• 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 stent deployment, remove slack from the delivery system catheter outside the patient.

• 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™ Solo™ 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). 

Potential Adverse Events 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

• More...