Covidien, a global provider of healthcare products, gained US Food and Drug Administration (FDA) approval for its EverFlex self-expanding peripheral stent system, for use in the superficial femoral artery (SFA) and /or the proximal popliteal artery (PPA).
The move follows the positive data from the Durability II investigational device exemption (IDE) trial which enrolled 287 subjects to evaluate lesions of up to 18cm and to specifically test the performance of a single long, up to 200 mm stent, in the SFA and PPA.
In the study, the primary endpoints included 30-day major adverse event rate and primary patency at one year, compared to performance goals. The EverFlex stent showed 67.7% of primary patency at one year when analysed by simple proportions of patient's patent, while using Kaplan-Meier time-to-event analysis, it was 77.2%, and the one-year stent fracture rate was 0.4%.
Prairie Vascular Institute, US, director and co-national principal investigator of trial Krishna Rocha-Singh said the Durability II trial is 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," Rocha-Singh added.
The EverFlex stent system will allow physicians to treat long lesions in peripheral arterial disease patients with a single stent, minimising the occurrence of stent fractures. Covidien Vascular Therapies chief medical officer Mark Turco said the Durability II findings demonstrate the safety and effectiveness of our EverFlex stents.
"Having an indication in the SFA - as well as a 200 mm stent - is imperative when treating peripheral arterial disease (PAD)," Turco added. Covidien manufactures, distributes and services a range of product lines in three segments including medical devices, pharmaceuticals and medical supplies.
Image: EverFlex self-expanding peripheral stent system from Covidien has been approved by the US FDA.