An FDA advisory panel offered a mixed view of Boston Scientific‘s (NYSE:BSX) Watchman heart device today, concluding it is probably safe but not particularly effective in reducing the risk of stroke in patients with a certain type of irregular heart beat.
Despite the lack of likely effectiveness, the panel voted 6-5, with 1 abstention, that the benefits outweigh the risks, with some panelists saying it should be an option for patients.
The FDA is not obliged to follow the advice of its advisory panels but typically does so. Boston Scientific is seeking approval of the device to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation who would typically be treated with warfarin, a standard oral treatment that has some limitations.
The advisory panel’s chairman, Dr. Richard Page of the University of Wisconsin School of Medicine & Public Health, broke the tied effectiveness vote. Page said he "always hopes I won’t need to vote," heartwire reported.
"I think this device is important technology," Page said. "[W]e’ve got to have it available, but it’s got to be available for the right people. … I think this device has a home, and we just need the FDA and sponsor to work together on a description and indication that’s appropriate and gives this important technology a place in our armamentarium to care for patients with atrial fibrillation at risk of … embolic stroke."
Several panel members said their "no" vote on efficacy the safety/benefit balance could change if Watchman were approved as an option for 2nd-line therapy or for patients who can’t take warfarin, according to heartwire.
Boston Scientific said it’s "committed to working with the FDA to address the panel’s comments."
"Today’s recommendation by the panel is another step toward making this innovative technology available to high-risk patients with non-valvular atrial fibrillation who are eligible for warfarin, but who have reasons to seek an alternative to long-term therapy," chief medical officer for rhythm management Dr. Kenneth Stein said in prepared remarks. "We continue to believe that the totality of the data for the Watchman device provide reasonable assurance of its safety and efficacy as a treatment alternative for these patients. We look forward to our ongoing discussions with FDA."
Leerink Partners analyst Danielle Antalffy said the panel vote hasn’t changed her view that the FDA will approve Watchman.
"All in, while Watchman barely squeaked by on the ever-important risk vs. benefit question and failed on efficacy, we continue to think Watchman will secure approval on: (1) A clearly compelling safety profile resulting in a unanimously favorable vote; and (2) a clear clinical need based on 14 public speakers vouching for benefits of the device," Antalffy wrote this morning in a note to investors, maintaining her $14 price target and "market perform" rating on the stock. "And while approval may be contingent on a more restrictive label, we believe BSX has been prudently conservative in targeting a $500M ultimate market opportunity that could still leave room for upside."
BSX shares yesterday closed up 3.1% at $12.14 apiece. The stock opened today at $12.09 and was trading at $12.12 per share as of about 10:15 a.m. Eastern, down 0.2%.
