Boston Scientific Granted European Approval For “Highly Anticipated” Heart Device

Boston Scientific Granted European Approval For “Highly Anticipated” Heart Device

The company is still looking for market approval of its Lotus Edge Valve System in the U.S. and Japan.

Boston Scientific’s next-generation heart implant device, the Lotus Edge Valve System, received market approval in Europe, the company said Monday.

According to the Marlborough, Massachusetts-based medical device maker—which employs about 7,100 workers in Minnesota—the device is still undergoing an approval investigation in the U.S. and Japan.

The Lotus Edge has already attracted global attention from medical professionals, such as Ian Meredith, who is the director of Melbourne-based hospital MonashHeart.
In a statement, Meredith viewed the “highly anticipated” device as “unique and valuable” in the treatment of aortic stenosis, or the narrowing of the aorta, which is the largest artery in the body.

“The ability to reposition the device precisely and prevent paravalvular leak, while incorporating new design characteristics, such as a more flexible catheter for easier delivery,” were noted as highlights of the new iteration of the Lotus Edge device, Meredith said.

According to the American Heart Association, an estimated three out of four patients succumb to aortic stenosis unless treated with a valve replacement. Boston Scientific has touted its new device as an effective alternative to open heart surgery in the treatment of aortic stenosis, which affects an estimated one in 20 adults older than 75 years.

The device’s Depth Guard technology is said to reduce interaction with the aorta and minimize leaking during insertion, a problem also referred to as paravalvular regurgitation. Paravalvular regurgitation is said to affect as many as 17 percent of all surgically implanted prosthetic heart valves, and can typically lead to a patient experiencing heart murmurs. Boston Scientific said its Depth Guard technology was created with a goal of reducing the need for a permanent pacemaker.

“The Lotus Edge Valve System is designed to give physicians increased control during implantation,” said Kevin Ballinger, president of interventional cardiology at Boston Scientific. Ballinger added that he hopes the device “can help provide a more precise, predictable procedure to ensure the best patient outcomes.”