The FDA’s Circulatory System Device Panel has voted 13:1 in support of Boston Scientific’s Watchman™ Left Atrial Appendage Closure device, a decision that must surely be enough to see it become the first of its kind to gain approval next year.
There was a building sense of anticipation as the FDA’s Circulatory System Device Panel meeting of December 11th hoved into view. Would the panel of experts endorse Boston Scientific’s Watchman Left Atrial Appendage Closure device rather more strongly than they did last time it came across their table in 2009? Last time it gained a 7:5 vote in favour, but then didn’t get past the FDA so remained unapproved.
This time it seems the company has collected enough good quality supporting data to assuage most of the concerns, as the committee voted favorably by a majority of 13:1 that the benefits of the device outweigh the risks. The same vote resulted when asked about safety. What happens next is that the FDA will make a decision on the approval of the Watchman device some time in early 2014, taking into account yesterday’s vote in coming to its decision.
So what swung the panel this time around? Well, it’s fair to say their are cardiology professionals who simply don’t like the concept of physical closure of the LAA using an indwelling device. They say it represents a blunt instrument and one that doesn’t adequately outperform blood thinning drugs in stroke prevention. Furthermore it results in an effectively permanent implant, which would be virtually impossible to remove. That’s what the clinical data had to face down, and indeed the vote followed a review of two randomized control trials, PROTECT AF and PREVAIL, as well as from the CAP (Continued Access Protocol) registry. This vast amount of data collection has left the Watchman device as the most studied left atrial appendage closure device and the only one with long-term clinical data from 2,000 patients and with almost 4,900 patient-years of follow-up in clinical trials, says Boston Scientific. So it seems the panel concluded that for patients for whom long term blood thinning is not an option, Watchman just might be.
Interestingly, the Watchman device received CE Mark in 2005.
“We are pleased with the outcome of today’s Panel, which represents an important milestone toward making this innovative technology available to patients with AF at higher risk for stroke who need an alternative to long-term warfarin therapy,” said Kenneth Stein, M.D., Chief Medical Officer, Cardiac Rhythm Management, Boston Scientific. “We appreciate the opportunity to present our comprehensive data supporting the Watchman technology and look forward to continuing discussions with the FDA regarding the Panel’s comments.”
Source: Boston Scientific Corporation, PR Newswire