PREVAIL, the much anticipated second major trial of the Boston Scientific device called Watchman was a bust. The trial endpoints were changed in midstream of the trial, but it still did not help. The efficacy endpoint was not met this time, contradicting the first major trial, PROTECT, where a small efficacy was found. (Even if the statistical endpoints were met, the primary endpoint was a clinically meaningless composite of stroke, systemic embolization, and cardiovascular caused death.)
The safety of the device has always been the show stopper. In the PROTECT study, debris embolized from the aorta and heart up to the brain causing a 9% stroke rate due to the procedure. That was far greater than the stroke risk from atrial fibrillation, making it unapprovable to an FDA advisory committee. In the PREVAIL trial, the stroke rate was still nearly 5% under the ideal conditions of the best cardiologists.
The PREVAIL data were supposed to be the star of the late breaking sessions at the ACC meeting. When BSX realized that they had a dud on their hands, they tried to pull a fast one and present partial data only, to spin the bad marketing news. When outrage prevented that, they conveniently sabotaged the data by leaking it ahead of the embargo, forcing the ACC to cancel to presentation (or was the ACC, which gets most of its funding from industry, complicit with this PR scam?).
Astonishingly, several sell side analysts, such as Larry Biegelsen, who blew the call are defending the data. Some models have $300 Million in revenue factored in from Watchman.
Venture Capitalists wasted $90 Million on the Watchman device through Atritech, then Boston Scientific acquired it for $100 Million in cash plus milestone, plus more research and development since the acquisition. The Watchman device is unlikely to be approved by the FDA. This was yet another incompetent M&A deal by Boston Scientific, squandering investor cash. We continue to believe that Boston Scientific would be worth more to shareholders liquidated and sold as sum of parts.
Finally, the ACC has clearly lost all credibility. After allowing the controversial Marty Leon CRF to take over a portion of the meeting years ago, and after firing the controversial CEO of the ACC, we now get this from the 2013 meeting. As the funds from the struggling medical device and pharmaceutical companies shrink, in the wake of off-patent Lipitor and the demise of stents, the meetings are more desperate than ever, and under complete control of the industry hands that feed them.