Feature | December 12, 2013

FDA Panel Votes Favorably on Boston Scientific's Watchman Transcatheter LAA Occluder

Watchman is first transcatheter left atrial appendage occluder to go before FDA for approval

Watchman, LAA occluder, atrial fibrillation
December 12, 2013 — The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted favorably Dec. 11 in a 13-1 vote that the benefits of the Watchman Left Atrial Appendage Closure (LAA) device outweigh the risks. The FDA Panel also voted 13-1 that there is reasonable assurance the device is safe and effective. The FDA will take into account the panel's review in its final decision on approval of the Watchman device. The company expects a decision from the FDA in the first half of 2014.
 
The Watchman is the first transcatheter LAA occluder device to go before the FDA for review. The device is designed to replace warfarin therapy for patients with atrial fibrillation (AF) to prevent blood clots from forming in the LAA. The device is delivered in a cath lab via catheter through a septal wall puncture from the right into the left atrium. The device self expands into the LAA and is anchored by small barbs. It has a fabric covering with facilitates endothelization. 
 
"We are pleased with the outcome of today's panel, which represents an important milestone toward making this innovative technology available to patients with AF at higher risk for stroke who need an alternative to long-term warfarin therapy," said Kenneth Stein, M.D., chief medical officer, cardiac rhythm management, Boston Scientific. "We appreciate the opportunity to present our comprehensive data supporting the Watchman technology and look forward to continuing discussions with the FDA regarding the panel's comments."
 
The vote of the committee followed a review of clinical data from two randomized control trials, PROTECT AF and PREVAIL, as well as from the CAP (Continued Access Protocol) registry. Watchman is the most studied LAA closure device and the only one with long-term clinical data from 2,000 patients and with almost 4,900 patient-years of follow-up in clinical trials. The Watchman device received CE mark in 2005. In the United States, it is an investigational device, limited to investigational use and not available for sale.
 
The LAA is a thin, sack-like appendix arising from the heart and is believed to be the source of a majority of stroke-causing blood clots in people with AF. The most common treatment for stroke prevention in patients with AF is blood-thinning warfarin therapy. Despite its proven efficacy, long-term warfarin therapy is not well tolerated by some patients and carries a significant risk for bleeding complications. Due to the drug’s narrow therapeutic window it also requires regular blood test monitoring. 
 
For more information: www.bostonscientific.com 
 
Bottom of Form
 

Related Content

Edwards, Sapien 3 transcatheter heart valve, Canada, approval
News | Heart Valve Technology| July 27, 2016
Edwards Lifesciences Corp. announced that Health Canada has approved the Edwards Sapien 3 transcatheter heart valve for...
PCI outcomes, public reporting, high-risk patients, JAMA Cardiology, Beth Israel Deaconess Medical Center study
News | Cath Lab| July 27, 2016
July 27, 2016 — A number of states mandate public reporting of mortality outcomes following certain cardiac procedure
Abbott, Absorb bioresorbable stent, dissolving, UAB, University of Alabama at Birmingham, first in state
News | Stents Bioresorbable| July 26, 2016
On July 20, Massoud Leesar, M.D., of University of Alabama at Birmingham Hospital implanted a patient with Absorb, the...
CMS, Overall Hospital Quality Star Rating, national distribution, quailty of care
News | Business| July 26, 2016
July 25, 2016 — The Centers for Medicare and Medicaid Services (CMS) announced that it expects to launch its new Over
pros and cons of new anticoagulation therapies, anticoagulants, dabigatran, Pradaxa, novel oral anticoagulants, NOACs, rivaroxaban, Xarelto, apixaban, Eliquis
Feature | Antiplatelet and Anticoagulation Therapies| July 26, 2016 | Heidi Olson, Pharm.D
With the recent introduction of several novel oral...
Stryker Sustainability Solutions, Angiodynamics Soft Vu Omni Flush Angiographic Catheters, recall
News | Angiographic Catheter| July 25, 2016
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling Angiodynamics Soft Vu Omni Flush...
Million Hearts Cardiovascular Disease Risk Reduction Model, CMS, reduce heart attacks and strokes, participants
News | Patient Engagement| July 22, 2016
July 22, 2016 — The Centers for Medicare & Medicaid Services (CMS) recently announced 516 awardees in 47 states,
heart failure, after first heart attack, cancer risk, JACC study
News | Cardiac Diagnostics| July 21, 2016
People who develop heart failure after their first heart attack have a greater risk of developing cancer when compared...
Absorb, bioresorbable stent, BVS

The Abbott Absorb stent gained FDA clearance in July 2016. It has metallic markers at each end so it can be visualized for proper positioning under angiographic X-ray imaging. 

Feature | Stents Bioresorbable| July 21, 2016 | Alphonse Ambrosia, D.O.
Some have labeled bioresorbable scaffolds (BRS), also known as bioresorbable stents, as the fourth evolution of inter
Sponsored Content | Videos | Inventory Management| July 19, 2016
You have bigger priorities than managing inventory.
Overlay Init