News | Left Atrial Appendage (LAA) Occluders | November 20, 2015

Boston Scientific Receives CE Mark For Next-generation Watchman FLX LAA Closure Device

First implants occur in Europe, commencing limited market release

Boston Scientific, Watchman FLX, LAA closure device, CE mark, first European implants

November 20, 2015 — Boston Scientific announced the first implants of the Watchman FLX left atrial appendage closure (LAAC) device – the latest generation of the Watchman device – occurred in Europe following CE mark approval.

Watchman FLX device implants were performed last week by Horst Sievert, M.D., department head of cardiology and vascular medicine, Sankt Katharinen Hospital, in Frankfurt, Germany; by Vivek Reddy, M.D., director of cardiac arrhythmia services for The Mount Sinai Hospital, at Na Homolce Hospital in Prague, Czech Republic; and Saibal Kar, M.D., director of cardiovascular intervention center research at Cedars-Sinai Heart Institute, at MC Medicor in Izola, Slovenia.

The Watchman FLX LAAC device is a catheter-delivered heart implant designed to close the LAA in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF. 

"The closed-end design of the Watchman FLX device and the ability to fully recapture and reposition this device make it a very promising option for treating indicated patients with simple to the most complex anatomies," said Sievert. "With nearly a decade of experience implanting the original Watchman device, it has been exciting to see the advancements of this technology from Boston Scientific and take part in the first implants of this device in Europe."

The first-generation Watchman device was CE marked in 2005 to prevent thrombus embolization from the LAA and reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation (AF) who are eligible for anticoagulation therapy. In 2012 the CE Mark indication was expanded to include those who have a contraindication to anticoagulation therapy. AF affects approximately 15 million patients worldwide and is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. Patients with AF have an increased risk of stroke due to the migration of clots formed in the LAA. 

This approval marks the second significant regulatory and commercial milestone for the Structural Heart business of Boston Scientific this year, following the U.S. Food and Drug Administration (FDA) approval of the first-generation Watchman device in March 2015. In the United States, the Watchman device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with: non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores; are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.

Commercialization of the Watchman FLX device is currently in a limited market release and will become more widely available to approved EU countries in the first half of 2016. The device is not available for sale in the United States.

For more information: www.bostonscientific.com

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Mississippi Surgical and Vascular Center Uses Toshiba Ultimax-i FPD to Save Patients' Limbs
News | Angiography| September 14, 2017
The southern U.S. sees some of the highest numbers of chronic medical conditions, such as peripheral artery disease...
Overlay Init