Boston Scientific completes enrolment for Innova stent trial

Boston Scientific has announced the completion of patient enrolment for a new study assessing the 12-month safety and effectiveness of its Innova Self-Expanding Stent System.

Entitled SuperNOVA, the trial is intended to demonstrate the effectiveness of the stent in the treatment of narrow or blocked arteries above the knee, a problem often associated with peripheral artery disease.

The study has enrolled 299 patients at 51 sites in the US, Canada, Japan and Europe, with the data set to support regulatory submissions in the former three territories.

Boston Scientific received European CE Mark approval for the device in May 2012.

Jeff Mirviss, president for peripheral interventions at Boston Scientific, said: "Peripheral artery disease affects millions of people globally, diminishing their quality of life and putting them at increased risk of limb amputation, stroke, heart attack and even death."

This comes after the firm launched its new OptiCross Coronary Imaging Catheter in the US, Europe and Japan last month.