Readers of our pages will probably be familiar with Boston Scientific Corporation’s WATCHMAN Left Atrial Appendage Closure Device, which has now received U.S. FDA approval. The plan now is that the device will be made available to the company’s U.S. clinical study centers with additional, specialized centers added as physicians are trained on the implant procedure.
Background
The Watchman device works by closing off the part of the heart known as the left atrial appendage. This structural feature has been associated with generation of blood clots that can be liberated into the circulation in patients who suffer certain kinds of atrial fibrillation. The device as such offers a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy. It has been commercially available internationally since 2009 and is the leading device in percutaneous left atrial appendage closure globally. Indeed Watchman has been used in more than 10,000 patients.
The FDA approval is based on the Boston’s WATCHMAN clinical program which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up. The WATCHMAN clinical program provided strong evidence that the WATCHMAN Device can be implanted safely and reduces the risk of stroke in eligible patients while enabling most patients to discontinue warfarin. Additionally, a meta-analysis of all of the randomized trial data demonstrated that while ischemic stroke reduction favored warfarin, the WATCHMAN Device provided patients with a comparable protection against all-cause stroke and statistically superior reductions in hemorrhagic stroke, disabling stroke, and cardiovascular death compared to warfarin over long-term follow-up.
Physician comments
“The WATCHMAN Device is an important step forward in stroke management for patients with AF,” said Vivek Reddy, M.D., Director of the Cardiac Arrhythmia Service at the Mount Sinai Medical Center and co-principal investigator of the PROTECT AF and PREVAIL studies. “We know that up to 40 percent of patients who are eligible for oral anticoagulation do not take it for numerous reasons1, highlighting the need for additional treatment options. The WATCHMAN Device is a breakthrough treatment providing those patients who are suitable for warfarin with an implant-based alternative to long-term warfarin therapy while still reducing the risk of stroke.”
Company comments
“Today marks a defining moment in the company’s journey towards establishing left atrial appendage closure therapy in the United States. Boston Scientific is proud to offer this potentially life-changing stroke risk treatment option to high-risk patients with AF who have a reason to seek a non-drug alternative to warfarin. This therapy could free them from the challenges of long-term warfarin therapy,” said Joe Fitzgerald, executive vice president and president, Rhythm Management, Boston Scientific. “FDA approval of the WATCHMAN Device is another example of Boston Scientific delivering on its commitment to bring meaningful innovations to patient care.”
Source: PR Newswire
published: March 16, 2015 in: Approval/Clearance, Boston Scientific, Cardio, Clinical Studies/Trials, Neuro