WATCHMAN Left Atrial Appendage Closure Device Gets CE Mark for Expanded Use

Patients with atrial fibrillation (AF) are at an increased risk of stroke that can originate in the left atrial appendage (LAA), an evolutionary holdover that most think has no purpose.  The inlet does create a space where a thrombus can form and lead to an ischemic stroke.  Anticoagulants like warfarin are typically the desired approach, but patients carry substantial risk of internal bleeding, either spontaneously or with minor trauma.

The WATCHMAN device from Boston Scientific was developed to fill the space of the LAA and capture any clots that form within. Now the company received expanded indication approval in Europe to offer this treatment to AF patients that have a contraindication to the currently available anticoagulants.  Take a look at our flashbacks below for our previous coverage of the WATCHMAN over the last six years as it’s been progressing through the clinical trials.

Additionally, the announcement reports acceptance of LAA closure devices for AF treatment by the European Society of Cardiology:

In addition, the European Society of Cardiology (ESC) today announced the inclusion of LAA closure devices in the revised “Guidelines for Management of Patients with Atrial Fibrillation.”  The recommendation was based on the expansive WATCHMAN LAA closure device clinical data, collected on more than 2,000 patients and exceeded the equivalent of 4,000 patient years of follow up across multiple studies.  These studies include the PROTECT AF trial, which proved the WATCHMAN device was non-inferior to warfarin and demonstrated a 38 percent relative risk reduction for stroke, cardiovascular death and systemic embolism compared to long-term warfarin therapy; the ASA Plavix (ASAP) Registry, which demonstrated a 77 percent reduction for ischemic stroke in patients contraindicated to warfarin; and the Continued Access PROTECT AF trial, which demonstrated improved procedural outcomes with experience.

Press release: Boston Scientific WATCHMAN® Left Atrial Appendage Closure Device Receives CE Mark Approval For Expanded Use

We’ve been watching the Watchman — see these posts for more: JoVE Video: The WATCHMAN Left Atrial Appendage Closure Device; Watching the Watchman; Still Watching the Watchman; Watching the Watchman (again); Watchman: Plug Up Heart to Prevent Strokes