Positive data for EverFlex SEP Stent System in PAD published- Medtronic

The EverFlex self-expanding peripheral stent system from Medtronic can provide sustained patency in the treatment of long, complex lesions in the superficial femoral (SFA) and popliteal arteries, according to the three-year results of the DURABILITY II study, which are reported in the recent issue of Catheterization and Cardiovascular Intervention. DURABILITY II, a prospective, multi-center, non-randomized, single-arm study is the first controlled study to focus on treating long, complex lesions, and to specifically test the use of a single nitinol stent in the SFA. It enrolled 287 patients at 44 centers in the United States and Europe.

The mean lesion length was 8.9 cm and included 48.1 percent occluded arteries with 43.2 percent severely calcified lesions. Subjects were followed annually for three years with independent ultrasound core lab adjudicated duplex ultrasound to determine stent patency, radiograms of the stented extremity to assess stent fractures and ankle brachial indices. Duplex ultrasound-assessed patency (PSVR <2.0) rate at three years was 60 percent; freedom from loss of primary patency was significantly higher for lesions <=8 cm at 71 percent, compared to lesions >8 cm at 50.5 percent (p = 0.0001). The three year freedom from target lesion revascularization (TLR) was 70 percent. The three-year stent fracture rate was 0.9 percent.