Boston Scientific (NYSE:BSX) reportedly halted European sales of its the next generation of its anti-stroke device, the Watchman FLX, after receiving reports of device embolization.
Spokeswoman Trish Backes told TCTMD that there were 6 device embolizations in 207 (2.9%) European implantations of the Watchman FLX, an implant that designed to occlude the heart’s left atrial appendage. One of those patients died from complications related to an infection suffered after the device was retrieved.
The 1st-generation Watchman device showed a 30-day embolization rate of 0 to 0.7% in trials, and a post-approval registry called Ewolution showed a rate of 0.2%. The Watchman FLX device won CE Mark approval in the European Union last November; the original iteration won FDA approval in March 2015.
Watchman FLX will be taken off the shelves until Boston Scientific can determine what’s causing the unexpectedly high embolism rate, Backes told the website.
“With [the original] Watchman, we’re really confident. We’ve seen really low embolization rates,” she said. “With the robust clinical training program that we have in place for physicians before they start implanting the device, we feel really good about that. This doesn’t impact what we’re doing in the U.S. or what we’re doing with the current Watchman device. It’s not raising any concerns for us for the current device.”
Medical officers with the Marlborough, Mass.-based company, speaking at the annual conference of the American College of Cardiology, said they’ll look at whether physician training or implant technique are factors. The company said the sales halt for Watchman FLX will not affect its structural heart sales forecast of $175 million to $200 million this year.
Boston Scientific said earlier this week at ACC 2016 that a review of the 1st 1,000 Watchman patients found similar results as in pre-market trials.
Material from Reuters was used in this report.
