U.S regulators said Monday that the surgery required to implant Boston Scientific’s anti-stroke device might reduce its effectiveness and said more careful review is needed before making an approval decision.
The Natick-based company’s Watchman device failed in new trials to break clots in the heart’s left atrial appendage. The device also failed to show it was effective as warfarin in preventing stroke.
Boston Scientific is seeking approval of Watchman for patients who are eligible to use the warfarin, a blood-thinner and current standard treatment for stroke prevention.
“It is critical that advisory panel members review the totality of the data in making these determination as each component of the data set has strengths and limitations,” the staff said.
Advisors to the U.S. Food and Drug Administration will meet Wednesday and recommend whether the FDA should approve the product for use in patients, according to documents posted online. Boston Scientific declined to comment until the FDA panel process had concluded, according to spokeswoman Jen Saunders.
An FDA advisory panel recommended approval of the Watchman in 2009, but the agency ultimately decided another study was needed to evaluate its safety and effectiveness. The Watchman has been on the European market since 2005.
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