Boston Scientific Corp. said its study on a novel heart device to prevent strokes will be presented in full at a meeting March 9, after the company surprised investors and organizers earlier this week with plans to release only a limited look at the safety data.
Initial findings from the clinical trial, called Prevail, will be released at the American College of Cardiology meeting in San Francisco, the Natick, Massachusetts-based company said in a statement. The study tracked the safety of the Watchman device for a week after surgery and examined whether it reduced the risk of stroke, clots or death 18 months after treatment.
The Watchman is used to seal off a reservoir in the upper chamber of the heart that allows blood to pool and form clots that can trigger strokes. If successful, it will give patients an alternative to blood-thinning drugs that cut stroke risk, while boosting the potential for uncontrolled bleeding. Boston Scientific officials have estimated the market for the device at $500 million a year.
“This is truly a late-breaking clinical trial presentation,” Ken Stein, chief medical officer of the company’s cardiac rhythm management group, said in today’s statement. “The last patient six-month follow-up occurred in January and the team has been working diligently to complete the preliminary analysis of the data.”
The preliminary analysis that looked at how the device performed through the first 18 months, including and excluding complications during the first week after surgery, will be presented, Stein said. The final analysis will be completed in the coming weeks and is expected to be part of an application to the U.S. Food and Drug Administration for approval of the device, he said.