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Resilient trial demonstrates better results for LifeStent

Edwards Lifesciences has announced superior results in the Resilient trial for the LifeStent self-expanding stent in treating peripheral arterial disease in the superficial femoral artery and proximal popliteal artery.

The LifeStent self-expanding nitinol stent is a percutaneously-delivered flexible mesh tube that expands when deployed to prop open a diseased vessel and is specifically designed to withstand bending and twisting of the superficial femoral artery (SFA).

Barry Katzen, founder and medical director of Baptist Cardiac and Vascular Institute, and co-principal investigator for the Resilient trial, said: “The Resilient trial is a randomized, multi-center study using the flexible LifeStent self-expanding stent in the understudied and challenging SFA region. The results of this trial show the statistical superiority of the LifeStent self-expanding stent versus balloon angioplasty alone as the need for follow-up intervention was 13% versus 54%, respectively, at 12 months.”

The Resilient trial further demonstrated the SFA patency rate was 80% for patients who received the LifeStent self-expanding stent as against 38% for patients with balloon angioplasty alone.

John Laird, medical director of the vascular center at the University of California, Davis Medical Center, said: “Results from The Resilient trial are expected to establish the LifeStent self-expanding stent as an alternative for patients evaluating treatment options for SFA disease. Millions of patients suffering from PAD are in need of a clinically proven therapy that will improve their quality of life, allow them to be more active and walk without pain.”