FDA Approves Abbott Vascular's Supera Peripheral Stent to Treat SFA/PPA Disease

March 28, 2014—Abbott Vascular (Abbott Park, IL) announced that its Supera peripheral stent system has received US Food and Drug Administration (FDA) approval for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA). The Supera device is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the SFA and/or PPA with reference vessel diameters of 4 to 6.5 mm and lesion lengths up to 140 mm.

Abbott Vascular added the Supera stent to its product portfolio with the acquisition of Idev Technologies, Inc. (Webster, TX) in August 2013. The Supera stent has also received European CE Mark approval for the treatment of PAD.

According to the company, the Supera stent mimics rather than resists the natural movement of leg arteries using interwoven wire technology to restore blood flow to the treated area while offering strength and flexibility for resistance to fractures and kinks.

The Supera stent was evaluated in the SUPERB clinical trial, which was used to support FDA approval. The company noted that the SUPERB trial data have shown that the Supera stent is highly effective in opening up blocked blood vessels in the upper leg, even in difficult cases, and results have been shown to last over time. In addition, during the first year after treatment with the Supera stent there were no stent fractures, and at 2 years there was a very low stent fracture rate of 0.5%. 

Kenneth Rosenfield, MD, who served as Principal Investigator of the SUPERB trial, commented in the company’s press release, “Doctors are increasingly identifying PAD as a major cause of leg pain, which can limit people’s ability to live a healthy lifestyle. Treatment with the Supera stent, as shown by the results of the SUPERB study, is very effective in easing leg pain, enabling the majority of patients to resume their activities.” Dr. Rosenfield is Section Head of Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts.

"Because the individual wires cross in a woven pattern and are not welded to each other, it allows for a lot of movement and flexibility as the stent is twisted, turned, or bent," commented Charles A. Simonton, MD, FACC, FSCAI, Chief Medical Officer, Abbott Vascular. "The individual wires move independently and can slide back and forth across each other, allowing the stent to adapt to the anatomy. This is especially important in the distal part of the SFA, where there is a lot of twisting and torque forces."