Test pipeline underpins growth strategy for Watchman LAAC

The investment in the clinical development program will underpin Boston Scientific’s strategy to increase adoption of the Watchman left atrial appendage closure (LAAC) device, said Angelo De Rosa, global vice president and general manager of the Watchman system. Heart rhythm news.

De Rosa took over the Watchman team in Boston in September 2023, shortly before the latest generation of the Watchman FLX Pro won FDA approval. The company is also pursuing CE marking for the FLX Pro system, which is expected in 2025, and hopes that changing treatment guidelines could spur adoption of the device outside the U.S., where operators have been adopting the therapy more quickly.

Watchman is indicated to reduce the risk of stroke in patients with nonvalvular atrial fibrillation (AF) who require an alternative to oral anticoagulation therapy. The latest version, Watchman FLX Pro, features a polymer coating designed to reduce the risk of device-related thrombosis (DRT) after implantation, as well as radiolucent markers to aid positioning with fluoroscopy, and a larger size to accommodate a wider range of patients.

“Watchman is definitely one of the most studied devices in the medical technology space because the level of investment and the number of trials the device has gone through is significant,” De Rosa said, citing the existing body of data that has been collected to confirm the device’s safety and effectiveness to date. Boston Scientific is supporting a series of further trials as it seeks to expand the therapy, he said. Heart rhythm newsThe aim of this paper is to provide information for the upcoming European AF treatment guidelines, which are planned to be updated in 2028. The latest US guidelines raised the class of recommendation for LAAC to level 2a.

Several studies are in the pipeline to strengthen the evidence base for Watchman, the first of which is the OPTION study, a 1,600-patient study comparing Watchman with an oral anticoagulant for protection against stroke in patients with AF who have undergone or will undergo LAAC ablation. Results from the OPTION study are expected later this year.

“This is truly a groundbreaking study, and we are optimistic that it will help more electrophysiologists become familiar with the Watchman therapy, but we already have a huge demand for what we call sequential or combined procedures,” De Rosa said.

“It really opens the door to asking, if the OPTION is positive, ‘what if we do these two procedures at the same time?’ what’s best for the patient, what’s best for the hospital in terms of resource utilization, it’s the best of both worlds.”

The OPTION trial is followed by the CHAMPION-AF trial, which is investigating Watchman FLX as a first-line option versus anticoagulation in patients with atrial fibrillation who are able to tolerate long-term anticoagulation but are considering a single-use device option to reduce the risk of stroke.

“We are also working with the Canadians on the LAAOS-4 study, which is a large, randomized clinical trial to assess whether the highest-risk patients benefit from combined Watchman and oral anticoagulation. We are also planning to start another study called SIMPLAAFY, which will look at a simplified postoperative regimen with the Watchman FLX Pro device,” De Rosa comments.

“With a strong research process, we are looking at the clinical and economic evidence and are working towards a final guideline change. The next European AF guideline will be published in 2028, so our strategy is to publish the data from the OPTION and CHAMPION-AF studies well in advance and combine all the possible evidence we can get to change the guideline at that time and raise the bar we have today for Watchman.”

“Currently, the Watchman device is not part of the stroke treatment for many AF patients until they have tried all sorts of medications and combinations of medications. The problem is that the patient gets worse while they are on those medications, so they are not getting the most benefit from the device. We see an opportunity to change that time frame and help more patients get treatment earlier in the disease.”