Boston’s WATCHMAN® LAA Closure Device Sees Its CE Mark Extended To Include AntiCoagulant-Limited Patients

In short

It’ll be a good night in Munich for Boston Scientific as news breaks at ESC that European regulators have approved an expanded indication for the the company’s WATCHMAN® Left Atrial Appendage (LAA) Closure Device. The new indication presents a new option for patients with atrial fibrillation (AF), and a contraindication to warfarin and the newer oral anticoagulants.

Background

Atrial fibrillation affects approximately 15 million patients worldwide with sufferers at an increased risk of stroke due to the migration of clots formed in the LAA. Blood-thinning medications have previously been the only therapy for reducing stroke risk in these patients.

Developed by Atritech, which Boston Scientific acquired in March 2011, the WATCHMAN device is introduced into the heart via a catheter through a vein in the groin. It is intended to close off the LAA working by capturing any clots that may form in the appendage, reducing the risk of stroke and potentially eliminating the need for long term use of blood thinning medications.

This extended CE Mark approval of the WATCHMAN device to include patients who are unable to take warfarin or other anticoagulants, was based on results from the ASAP study. The original CE mark approval for use in Europe was gained in 2005 and some countries in Asia in 2009.

Boston Scientific recently completed enrollment in the PREVAIL study, a confirmatory study designed to gain U.S. FDA approval. Patient follow up for the study is six months.

Company comments

“The expanded indication for WATCHMAN represents a significant advance for these patients who are at high risk of stroke, but who are unable to take conventional anticoagulant therapy,” said Kenneth Stein, M.D., chief medical officer of Boston Scientific’s Cardiac Rhythm Management Group. “WATCHMAN continues to demonstrate that it is an effective therapy for preventing stroke in patients with atrial fibrillation.”

More good news for Boston with ESC endorsement

In addition, the European Society of Cardiology (ESC) has 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.

Regulatory status

In the U.S., the WATCHMAN device is an investigational device, limited by applicable law to investigational use and not available for sale.

Source: Boston Scientific Corporation, PR Newswire