New-Generation Watchman FLX Device Pulled From European Shelves Over Embolism Concerns
CHICAGO, IL—Reports of device embolization during the limited market rollout of the next-generation Watchman FLX left atrial appendage closure device in Europe have caused manufacturer Boston Scientific to halt sales and pull the product from doctors’ shelves.
There have been six reports of device embolization out of 207 implants, for a rate of 2.9%, Trish Backes, senior communications manager for Boston Scientific, told TCTMD. One of those patients died due to complications related to postoperative infection after the device was retrieved percutaneously.
That rate is much higher than observed in clinical trials of the first-generation Watchman device, in which the 30-day embolization rate ranged from 0 to 0.7%. In the most contemporary dataset available—the EWOLUTION registry—device embolization occurred in just 0.2%.
The news was initially reported by the company during an analysts’ meeting at the American College of Cardiology 2016 Scientific Sessions here.
Watchman FLX, which is not available in the United States, was introduced in Europe in a limited fashion after it received CE Mark approval in November 2015. The device was available at 21 centers across nine European countries and was being implanted by 32 operators with experience using the first-generation Watchman device, Backes said.
The company does not have any initial guesses as to what is causing the higher-than-expected embolism rate and will be keeping Watchman FLX off shelves until an evaluation can be completed, she said.
For now, procedures can continue using the first-generation device, for which there is an adequate supply, Backes advised.
“With 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 US or what we’re doing with the current Watchman device. It’s not raising any concerns for us for the current device.”