FDA Clearance For Covidien’s Everflex™ Long Peripheral Stent

In short

It seems to be all Covidien news this week, not least the announcement that the company has gained FDA clearance for its EverFlex™ Self-Expanding Peripheral Stent System for use in the superficial femoral artery (SFA) and/or the proximal popliteal artery (PPA).

Background

Peripheral artery disease (PAD) occurs when leg arteries become narrowed or blocked by plaque, these blockages often resulting in severe pain, limited physical mobility and non-healing leg ulcers. According to the American Heart Association, approximately 10 million people in the U.S. suffer from PAD.

In January we posted an article about the results of the so-called DURABILITY II study, which can be found here. The study was an Investigational Device Exemption(IDE) Trial and results indicated that the device met all VIVA Physicians Inc (VPI) indicators of safety and effectiveness.

Now cleared by FDA, the EverFlex System, approved for peripheral indication in international markets since 2006, is now available in the United States, including a 200 mm stent length.

Clinician comments

“DURABILITY II is a landmark trial intended to study the patency and fracture resistance of placing a single nitinol stent in the superficial femoral artery. It provided the clinical evidence necessary to demonstrate that you can successfully treat long, complex lesions in the SFA with the EverFlex Self-Expanding Peripheral Stent,” said Dr. Krishna Rocha-Singh, MD, Director, Prairie Vascular Institute, Springfield, Illinois, and co-national principal investigator of DURABILITY II.

Advantage of long stents for peripheral lesions 

Until now, physicians often addressed longer lesions by overlapping multiple stents. Overlapping stents have a higher propensity to fracture, thereby increasing the potential for restenosis to occur. Being able to place one long stent, versus multiple shorter stents, may lead to better long term clinical performance.

Company comments 

“The DURABILITY II findings demonstrate the safety and effectiveness of our EverFlex stents,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “Having an indication in the SFA – as well as a 200 mm stent – is imperative when treating Peripheral Arterial Disease.”

Source: Covidien