The S.M.A.R.T. CONTROL® Vascular Stent System is indicated for use to improve luminal diameter in the treatment of patients with de novo or restenotic native lesion(s) of the superficial femoral artery and/or proximal popliteal artery with total length up to 150mm and with a reference vessel diameter ranging from 4mm to 7mm.
- Patients with a known hypersensitivity to nickel titanium
- Patients who cannot receive antiplatelet or anticoagulation 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.
- It is not recommended that stents be used in patients with a history of contrast media allergy/intolerance not amenable to pretreatment with steroids and/or antihistamines.
- Safety and effectiveness has not been demonstrated in patients with:
- Lesions that are either totally or densely calcified
- Patients with uncontrollable hypercoagulability and/or other coagulopathy
- Patients with confirmed pregnancy
- Pediatric patients
- Caution should be taken when stenting patients with poor renal function who, in the physician’s opinion, may experience further deterioration of renal function.
- It is important to use the correct stent size, as recommended in the Stent Size Selection Table (Table 2 provided in Section X –Instructions for Use). The stent may cause a thrombus or distal embolization, or it may migrate from the site of an implant down the arterial lumen.
- The device should only be used by physicians who are trained in such interventional techniques as percutaneous transluminal angioplasty and placement of intravascular stents.
- When catheters are in the body, they should be manipulated only under fluoroscopy.
- Failure to pre-dilate the lesion may impair the ability to remove the stent system after stent deployment.
- Before insertion of the primary dilatation catheter, the appropriate antiplatelet and anticoagulant therapy should be administered.
- To avoid the possibility of dissimilar metal corrosion, do not implant stents of different metals in tandem where overlap or contact is possible, with an exception of stents made of 316L stainless steel which are compatible with stents made of nickel titanium alloy.
- The long-term outcome following repeat dilatation of endothelialized stents is unknown at present.
- Do not use the delivery system with a power injection system.
Please refer to the Instructions For Use for complete information.