The Innovative WATCHMAN FLXTM Device Expands Patient Access, Improves Safety and Effectiveness
It wasn’t enough for Boston Scientific engineers that the WATCHMAN™ Left Atrial Appendage Closure Device (LAAC) was the only technology of its kind on the market to help reduce stroke risk in patients with non-valvular atrial fibrillation. Why not make it even safer and able to treat a larger population of patients?
That approach led to the WATCHMAN FLX, the next-generation device designed to offer increased ease of use for physicians and improved procedural outcomes for patients, including reduced complication risk and healing time.
"Since launching the original WATCHMAN technology in 2015, we have continuously collected feedback from our physician customers to further improve the design and allow even more patients to benefit from this procedure,” says Brian Tischler, director of research and development for the WATCHMAN Franchise at Boston Scientific.
Atrial fibrillation is a condition in which the upper heart chambers beat erratically and often so rapidly that blood is not efficiently pumped to the rest of the body. This can cause blood to pool and form clots in a small pouch at the top of the heart called the left atrial appendage (LAA). If a clot forms, it can travel to the brain, block blood flow and cause a stroke.
Atrial fibrillation is one of the leading causes of stroke, which is the top cause of long-term disability and the third leading cause of death.[i] [ii] Worldwide, more than 37 million people had atrial fibrillation in 2017; that’s up 33% since 1997 and it is expected to grow by more than 60% by 2050.[iii]
While blood thinners are typically the first line of defense against this condition, for some patients, blood thinners impinge on quality of life and pose risky side-effects, such as uncontrolled bleeding.
For those with atrial fibrillation that is not caused by heart valve problems (non-valvular atrial fibrillation), and for whom blood thinners are inappropriate or problematic, the WATCHMAN device offers an alternative. This catheter-delivered heart implant is designed to close the LAA and prevent blood clots from forming and leading to stroke.
While the original WATCHMAN device is proven to be safe and effective and has been used to treat more than 100,000 patients worldwide, some patients with challenging heart anatomies, such as a shallow appendage, were not good candidates for the procedure.
Working with physicians who detailed their challenging cases, Boston Scientific researchers spent several years and went through a few hundred prototypes – using measurements as small as the thickness of a single strand of hair – to develop the next generation device.
The WATCHMAN FLX is the first LAAC device that can be fully recaptured, repositioned and redeployed for precise placement.
“The newly designed frame makes it easier to implant and offers physicians the ability to safely enter and maneuver within the LAA,” says Tischler.
Unlike the original, the WATCHMAN FLX device is also available in more size options, making it possible to treat a wider range of patients. In July, WATCHMAN FLX received FDA approval and an R&D 100 award that recognized WATCHMAN FLX as an innovation that “will change the industry and make the world a better place in the coming years.”
“It’s a testament to the determination and ingenuity of our R&D teams,” says Tischler. “We’re proud to receive this recognition, but we’re already looking to what’s next.”
The teams working on the WATCHMAN device have yet to stop innovating and are looking to the future with the recently initiated CHAMPION-AF clinical trial, which will look at how the WATCHMAN FLX device stacks up against the latest blood thinners in preventing stroke.
“We’re hoping to bring the benefits of the WATCHMAN FLX device to more patients and help improve their health and quality of life,” says Tischler.
[i] CDC. Public Health and Aging: Atrial Fibrillation as a Contributing Cause of Death and Medicare Hospitalization --- United States, 1999. MMRW Weekly, Feb. 21, 2003 / 52(07);128-131. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5207a2.htm
[ii] Mayo Clinic, Atrial Fibrillation. https://www.mayoclinic.org/diseases-conditions/atrial-fibrillation/symptoms-causes/syc-20350624
[iii] Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke (2020).