Abbott Announces FDA Approval of Its Supera Stent to Treat People with Peripheral Artery Disease

Abbott announced that its Supera Peripheral Stent System has received U.S. Food and Drug Administration (FDA) approval to treat people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD). 

The Supera stent, which mimics rather than resists the artery’s natural movement, is an important advancement for many PAD patients, helping to ease their leg pain while walking.¹ Its proprietary interwoven wire technology restores blood flow to the treated area, while offering strength and flexibility. Specifically, the Supera stent is now approved to treat blockages in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA). Compared to other nitinol stents used to treat blocked blood vessels in the upper leg, the Supera stent is more flexible, stronger and resistant to kinks or fracture under vigorous movement.²

“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,” said Kenneth Rosenfield, MD, section head of Vascular Medicine and Intervention at Massachusetts General Hospital and the principal investigator of the SUPERB clinical trial, which evaluated the Supera stent.    

Data from the SUPERB clinical trial, which was used to support FDA approval of the Supera stent, have shown the Supera stent to be 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.¹ In addition, during the first year after treatment with the Supera stent there were no stent fractures, and at two years there was a very low stent fracture rate of 0.5 percent.¹ Stent fractures are a known risk of treatment with traditional metallic stents in the leg due to the frequency and type of movement in this part of the body.

Abbott expanded its product portfolio with the Supera stent through the acquisition of IDEV Technologies in August 2013. The Supera stent has CE Mark in Europe for treating blocked blood vessels caused by PAD.

About the Supera Peripheral Stent System. The Supera Peripheral 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. n

For more information, please visit the following website: https://www.abbottvascular.com/static/cms_workspace/pdf/ifu/peripheral_intervention/eIFU_Supera.pdf 

1. Supera^® Peripheral Stent System Instructions for Use. Data on file at Abbott Vascular. 
2. Data on file at Abbott Vascular.