According to a Reuters news report, Boston Scientific is temporarily suspending sales of Watchman FLX—the next-generation of its left atrial appendage closure device, Watchman. The news agency says the company is suspending sales in Europe because of a higher-than-expected rate of embolisms associated with the new implant.
The report states that Boston Scientific announced the suspension of sales at a investor meeting at the 2016 American College of Cardiology (ACC) confernece (2–4 April, Chicago, USA). It adds that, at this meeting, medical officers from the company said that Boston Scientific will look at whether physician training and implant technique are causing the higher-than-expected rate of device-related embolisms.
The report also comments that, according to company officials, suspending Watchman FLX sales in Europe will not affect the company’s revenue forecast this year of US$175 million to $200 million for its structural heart division that includes the device.
The Watchman FLX model was launched in some European markets in last year. Like the first-generation Watchman, it is designed to prevent strokes (by closing the left atrial appendage) in patients with atrial fibrillation.