Boston Scientific ’ s Vici venous stent meets primary endpoints at 1 year

Boston Scientific (NYSE:BSX) today touted 12-month data for its Vici venous stent in people with significant obstructions in the illiofemoral venous outflow tract. Researchers reported that the Vici stent met its primary efficacy endpoint with a primary patency rate of 84% at one year. Nearly 99% of people treated with the Vici stent were free from major adverse events at 30 days, Boston Scientific noted. “In treating patients with venous obstruction, the primary goal is to restore and maintain vessel patency to ensure the return of blood flow to the heart,” principal investigator Dr. Mahmood Razavi said in prepared remarks. “In these results, the Vici stent demonstrated excellent performance outcomes in a difficult-to-treat patient population, which translates to improvement of long-term symptoms and enhanced quality of life in these patients.” The results of the 170-patient trial will be used to support FDA approval for Vici, according to the president of Boston Scientific’s peripheral interventions unit, Jeff Mirviss. “This trial is unique in the fact that it studied a very challenging patient population,” he added. “Three quarters of the patients in this trial have chronic venous disease, which is a debilitating condition that patients suffer from pain and swelling and ulceration. It’s the toughest of the toughest of venous diseases. And the Vici stent performed extremely well in this difficult patient population. &#...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Featured Regulatory/Compliance Vascular Wall Street Beat Boston Scientific Source Type: news