FDA Approves Supera Stent for Peripheral Artery Disease
Pivotal trial shows 79% stent patency rate at 1 year
The FDA has approved the Supera Peripheral Stent System to treat patients with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD).
PAD occurs when fat and cholesterol buildup causes arteries outside of the heart to narrow, which reduces blood flow to parts of the body, most commonly the legs. The disease affects 12% to 20% of Americans 65 years of age or older and can cause leg pain, in addition to increasing the risk of heart attack or stroke.
The Supera stent system is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm.
According to the system’s developer (Abbott), the Supera stent mimics rather than resists the artery’s natural movement. Compared with other nitinol stents used to treat blocked blood vessels in the upper leg, the Supera stent is more flexible, stronger, and more resistant to kinks or fracture under vigorous movement, Abbbott says.
Data from the pivotal SUPERB clinical trial, which were used to support FDA approval of the Supera stent, have shown the stent to be effective in opening blocked blood vessels in the upper leg, even in difficult cases. In addition, during the first year after treatment, there were no stent fractures, and at 2 years there was a very low stent fracture rate of 0.5%. Stent fractures are a known risk of treatment with traditional metallic stents in the leg because of the frequency and type of movement in that part of the body.
The SUPERB (Comparison of the SUpera PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) study was a prospective, non-randomized, single-arm trial comparing percutaneous transluminal angioplasty (PTA) and primary stenting with the Supera Peripheral Stent System to performance goals of PTA alone in the treatment of atherosclerotic lesions of the native SFA or the superficial femoral and proximal popliteal arteries.
A total of 264 intent-to-treat (ITT) subjects were enrolled into the study. Eligible subjects had stenotic, restenotic (non-stented), or occluded lesions.
The study’s primary effectiveness endpoint was the primary stent patency rate at 12 months (360 ± 30 days). Of the evaluable subjects, 78.9% (180/228) met this endpoint, demonstrating statistical significance (P < 0.001) when the patency rate was compared with the study’s 66% performance goal.
The primary safety endpoint of the study was a composite of major adverse events, defined as death, target lesion revascularization (TLR), or any amputation of the index limb to 30 days (± 7 days). Of the enrolled ITT subjects with 30-day (± 7 days) evaluable data (n = 260), 99.2% (258/260) met the safety endpoint, demonstrating statistical significance (P < 0.001) when this rate was compared with the study’s 88% performance goal.