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Covidien EverFlex stent meets safety and efficacy endpoints

25 January 2012

stent

Covidien, a global provider of healthcare products, has reported the one-year results on the use of its EverFlex stent for superficial femoral artery stenting at the International Symposium on Endovascular Therapy (ISET) Conference.

The Durability II study enrolled 287 subjects with lesions up to 18cm in length at 44 investigational sites in both the US and Europe to demonstrate the safety and efficacy of a single self-expanding stent up to 20cm in length. In the trial, primary endpoints included 30-day major adverse event rate and primary patency at one year, compared to performance goals

In the study, the mean age of subjects was 68 years, with prominent comorbidities including hypertension, hyperlipidemia, and diabetes, and mean lesion length as measured by core laboratory was 89.1mm, while the mean normal-to-normal lesion length measured by sites was 109.6mm.

Co-National principal investigator of study Jon Matsumura said in another new chapter of minimally invasive treatment of peripheral arterial disease (PAD), Durability II evaluated a novel longer stent system that offers the option of single stent treatment of extensive symptomatic femoral artery disease.

The EverFlex stent system will allow physicians to treat long lesions in PAD patients with a single stent, minimising the occurrence of stent fractures. 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 one-year stent fracture rate of 0.4%.

Covidien Vascular Therapies president Stacy Enxing Seng said Durability II is part of a series of clinical trials focused on primary stenting as an important option in the treatment of PAD. "Our significant investment in these studies demonstrates Covidien's ongoing commitment to evidence-based medicine and clinically relevant innovation," she added.

The results from the Investigational Device Exemption study will support the pre-market approval application of the EverFlex stent system, which is currently under review by the US Food and Drug Administration.

Caption: Durability II evaluated a novel longer stent system that offers the option of single stent treatment of extensive symptomatic femoral artery disease. Image courtesy of Frank C Müller.