SUPERB Assesses Idev's Supera System in SFA Treatment

October 10, 2012—During a Late-Breaking Trials session at the VIVA 2012: Vascular Interventional Advances meeting in Las Vegas, Kenneth Rosenfield, MD, presented findings from the SUPERB study. SUPERB is a prospective, nonrandomized investigational device exemption trial designed to assess the safety and effectiveness of the Supera peripheral stent system (Idev Technologies, Inc., Webster, TX) in treating subjects with superficial femoral artery (SFA) and proximal popliteal artery disease compared to the VIVA objective performance goals.

A total of 264 subjects with de novo or restenotic/occlusive native lesions were enrolled in 34 sites. The mean lesion length was 8 cm, with 73% of the lesions having moderate to severe calcification. 

Dr. Rosenfield reported that primary patency of the SFA, defined as freedom from target lesion revascularization (TLR) and restenosis, at 12 months was achieved in 79% using a peak-systolic velocity ratio of ≤ 2 (80% using peak systolic velocity ratio ≤ 2.4), easily exceeding the efficacy performance goal of 66% (P < .001).

By survival analysis, the primary patency rate was 86%. Freedom from TLR was 90%. The primary safety endpoint was composite of all death, TLR, or any amputation of the index limb to 30 days, which was achieved in 99.6% of subjects—significantly higher than the safety performance goal of 88% (P < .001).

Independent core lab review of x-rays showed a stent fracture rate of 0%. There was a significant improvement in ankle-brachial index from baseline (0.73) to 12 months (0.92, P < .001). At 12-month follow-up, 87.2% of patients had an improvement in Rutherford-Becker score by at least one category, and exercise testing in a subgroup showed a statistically significant improvement in mean distance and time to onset of claudication. Results from Peripheral Artery Quality-of-Life (PAQ) Questionnaires showed a significant improvement in summary score (36.9 to 69; P < .001) and individual domains, indicating a positive impact on quality-of-life for patients treated with Supera stents.

The SUPERB trial demonstrated significantly better lesion patency and safety profile compared to the VIVA PTA objective performance goals without any stent fractures through 12-month follow-up. This trial has achieved the highest patency rate of any SFA stent trial and may set a new standard for SFA endovascular treatment, concluded Dr. Rosenfield.