Boston Scientific Suspends Watchman FLX Sales in Europe

April 4, 2016—According to a Reuters news report, Boston Scientific Corporation has temporarily halted sales of its second-generation Watchman FLX atrial fibrillation device in Europe due to a higher-than-expected rate of embolism. This model of the device was launched in select European markets in November 2015. 

The Watchman device is designed to seal off the left atrial appendage in which blood can pool and clot, possibly leading to stroke. The device provides an option for high-risk patients with nonvalvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. 

The company assess whether physician training and implantation technique are causing the higher-than-expected rate of device-related embolisms. This rate is comparable to the results seen when the current Watchman device was first released, the company stated.

The Watchman device was approved by the US Food and Drug Administration in March 2015 and is currently the only left atrial appendage closure device approved for use in the United States. The company advised that suspending Watchman FLX sales in Europe will not affect the company’s revenue forecast for this year of $175 million to $200 million for its structural heart division, which includes the Watchman device.