Boston Scientific eyes FDA with PAD stent

Boston Scientific has completed enrollment in a trial of Innova.--Courtesy of Boston Scientific

Boston Scientific ($BSX) has wrapped up enrollment in a multicenter trial of the Innova stent, a self-expanding treatment for peripheral artery disease the company hopes will help reverse its cardiovascular slump.

The study, dubbed SuperNOVA, looped in 299 patients with PAD at sites in the U.S., Canada and Japan, and Boston Scientific expects to use the resulting data to win regulatory approvals in all three countries. The company didn't disclose when it expects to launch the stent in each geography.

Innova uses a novel low-profile delivery system to prop open the arteries above the knee, and its flexibility makes it ideal for the challenging anatomies of the superficial femoral artery and proximal popliteal arteries, according to the company.

The device won its CE mark in 2012 and has been available in Europe ever since, and Boston Scientific believes getting it up for sale in the sizable markets of the U.S., Canada and Japan will help treat the world's 27 million PAD sufferers and improve the company's still-recovering cardiovascular business.

Last quarter, Boston Scientific pulled in $742 million in cardiovascular revenue, 1% below the same period last year, as a 3% decline in its larger interventional cardiology segment dragged down a 3% jump in peripheral interventions.

- read the announcement

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.