News

What are the chances of FDA approval for Boston Scientific's Watchman Heart Device?


Posted in Cardiovascular by Heather Thompson on March 13, 2013

The American College of Cardiology's annual conference conculed Monday and something curious happened with respect to Boston Scientific and its release of data from a clinical trial related to its Watchman Left Atrial Appendage closure device.

The company broke an embargo when it released results to investors instead of presenting them at the conference as planned. Later it ended up pulling the presentation altogether.

Photo Credit: Flickr use Eva the Weaver

And that wasn't the only controversy related to the trial known as PREVAIL.

But the bigger question now is whether FDA approves the device given that it only met two of its three end points. 

Senior Analyst Glenn Novarro at RBC Capital Markets that FDA approval is now less likely for the Watchman, whose results were eagerly anticipated at the ACC conference. Novarro pegs the odds for an approval at 50/50.

He expects that the product will end up in front of an FDA panel in the second hald of the year.

The product comes from Boston Scientific's acquisition of Minnesota-based startup Atritech for up to $375 million provided it met revenue and regulatory milestones. 

At the time, executives hailed the Watchman device.

"Left atrial appendage closure represents a significant growth opportunity for Boston Scientific.  We are impressed by Atritech's technology, and we have the sales and marketing infrastructure to help realize the full potential of the Watchman device," said former CEO Ray Elliott, in a news release announcing the acquisition in January 2011.

-- By Arundhati Parmar, Senior Editor, MD+DI

Related Content

U.S. Device Approvals "as Fast or Faster" than in Europe, says FDA's Hamburg

An Engineer Takes on FDA Clearance and Approval Processes


Tags:
Printer-friendly version
No votes yet

Login or register to post comments