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IDEV Presents Consistent Evidence Validating the Design of the Supera Stent

IDEV Technologies, a PEI partner, recently announced the presentation of consistent positive clinical outcomes of the Supera® Peripheral Stent System from its SUPERB pivotal US clinical trial and SUPERA 500 long-term registry conducted in Germany.

IDEV’s data confirms a robust and consistent growing body of clinical evidence for Supera’s highly differentiated, disruptive and proprietary stent design.

SUPERB, a Food and Drug Adminstration (FDA) Investigational Device Exemption (IDE) trial, demonstrated the highest patency rates in peripheral IDE stent trials for superficial femoral or proximal popliteal artery disease that have been publicly reported (86% based on survival analysis at 12 months). In addition, it is the first femoral-popliteal artery IDE trial to record zero stent fractures for bare or drug-coated nitinol-based technologies.

The SUPERA 500 Registry included a highly challenging real world patient population of 495 patients, 750 stents, and a mean stent length of nearly 13cm, with 45% and 41% of the Supera stents placed in the distal SFA and proximal popliteal artery, respectively. The one- and two-year patency rates were 84.1% and 73%, respectively, as measured by duplex ultrasound. Consistent with the SUPERB trial, there were zero reported stent fractures at one year and also at two years in the SUPERA 500 Registry.

Of the stent and SUPERB and SUPERA 500 Registry results, Christopher Owens, President and CEO of IDEV said:

“Supera® is first in a new class of stents, vascular mimetic stents, engineered to mimic the vascular anatomy of optimal flexibility and strength. The SUPERB and SUPERA 500 results validate the Supera® design as well as data previously reported in numerous single-site registries and retrospective studies. With this data, and additional studies soon to be released, we are building one of the most robust bodies of evidence in PAD. We will continue to develop the Supera® stent for other markets, lesion types and locations.”

For more information on the Supera® Stent, please visit the Supera® product page or speak to your local hospital representative. Alternatively, contact PEI directly on +353 1 419 6900.

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