It may have taken about a decade for Boston Scientific (NYSE:BSX) to win FDA approval for its Watchman device, but once it came the company wasted no time in getting the anti-stroke cardiac implant on the U.S. market.
Marlborough, Mass.-based Boston Scientific said yesterday that 3 U.S. patients received the 1st commercial implantations of the Watchman device this week.
The Watchman implant is designed to close off the heart’s left atrial appendage, preventing the formation of blood clots that could lead to a stroke. The FDA granted pre-market approval for the device March 13 for high-risk patients with non-valvular atrial fibrillation as an alternative to long-term warfarin therapy.
Boston Scientific said Drs. Shephal Doshi of Santa Monica’s Saint John’s Health Center and Saibal Kar of Los Angeles’ Cedars-Sinai Hospital performed the 1st commercial Watchman procedures.
"With today’s successful implantations of the Watchman device, we are changing the way we deal with stroke risk in high-risk patients with non-valvular atrial fibrillation," Kar said in prepared remarks. "For indicated patients like those who received an implant this week, the Watchman Device reduces the risk of stroke, without the need for long-term anticoagulation therapy and its subsequent bleeding risks."
"As physicians, we are always looking for new therapies to satisfy unmet patient needs," Doshi added. "There are many patients like the ones we treated this week with the Watchman device who are suitable for warfarin, but are not ideal candidates for chronic anticoagulant use. These patients now have a new, proven option to reduce their risk of AF-related stroke."