Boston Scientific has finally won FDA approval for its Watchman implantable that helps reduce strokes in patients with non-valvular atrial fibrillation.
The announcement came as good news for patients with a higher than average risk for stroke who want a drug-free alternative to the blood thinner warfarin. The device helps reduce strokes in patients with non-valvular atrial fibrillation.
Watchman is already approved in Europe and 75 countries around the world, yet only recently received FDA approval.
The FDA wanted to be really careful with this device because it’s a breakthrough device for patients who are indicated for atrial fibrillation to help reduce the impact of stroke. So the FDA was really smart in ensuring we had long-term clinical safety benefits for the device, which we do. We have over 10,000 implants around the world, so it’s a proven device that helps patients, so we’re really excited about bringing this to the United States. – Mike Mahoney, CEO, Boston Scientific on Fox News
Despite multiple roadblocks since 2010 and 2014, Boston Scientific finally gained the approval after many years of clinical trials involving some 2,400 patients.
The Watchman device is positioned within the left atrial appendage, acting as a filter that prevents thrombi from traveling toward the brain. The frame is made of Nitinol, a common shape memory alloy, and is available in five different sizes to match each patient’s own anatomy. It has 10 anchors that make sure that it stays aligned and in place, while the PET mesh promotes the growth of endothelial cells. – medgagdget.com
No time like the present
Little more than a week after securing FDA approval, Boston Scientific announced the first patients to receive the Watchman implantable underwent successful surgeries.
According to the company,
more than 5 million Americans suffer from an irregular heartbeat called non-valvular atrial fibrillation. Many of these patients are at increased risk of stroke, but as many as 40% of those patients eligible for oral anticoagulant therapy do not take this medication and may need a treatment alternative.
Dr. Shephal K. Doshi, M.D., director of Cardiac Electrophysiology and Pacing at Saint John's Health Center in Santa Monica, CA explains why the Watchman implantable is important for certain patients.
As physicians, we are always looking for new therapies to satisfy unmet patient needs. There are many patients like the ones we treated this week with the Watchman device who are suitable for warfarin, but are not ideal candidates for chronic anticoagulant use. These patients now have a new, proven option to reduce their risk of AF-related stroke.
Fast Facts about Atrial Fibrillation and Stroke
- Non-valvular atrial fibrillation (AF) is an irregular heartbeat that can create blood clots, stroke, heart failure, and other heart-related problems.
- AF is the most common cardiac arrhythmia, which currently affects more than 5 million Americans.
- Patients with AF have a five-fold amplified risk of stroke due to blood that stagnates from the improperly beating atrium and the resulting formation of blood clots.
- Twenty percent of all strokes occur in patients with AF.
- Stroke is more severe for patients with AF, as they have a 70% chance of death or permanent disability.
- The most common treatment for reducing stroke risk in patients with AF is the blood-thinner warfarin.
- Despite its confirmed effectiveness, long-term warfarin is not indicated or well-tolerated by some patients due to a significant risk of bleeding complications and many quality-of-life tradeoffs, including dietary restrictions and regular blood monitoring.
The Watchman device gained FDA approval based on clinical trials, which included more than 3,300 patients with 6,000 patient-years of follow-up to date.