Boston Scientific Receives CE Mark Approval for Lotus Edge Valve System
September 19, 2016—Boston Scientific Corporation announced European CE Mark approval for the Lotus Edge valve system, the company's next-generation transcatheter aortic valve replacement (TAVR) technology. The Lotus Edge valve system will be available to select centers in Europe, with commercial site expansion accelerating as physicians and centers become fully trained.
According to Boston Scientific, the Lotus Edge valve system is indicated for TAVR in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement.
In comparison to the earlier Lotus valve system, this next iteration incorporates a more flexible, lower profile catheter designed to improve ease of use and accommodate tortuous anatomy. A new feature in the Lotus Edge valve system is the company’s Depth Guard, a design element intended to reduce the need for a permanent pacemaker. The Lotus valve system is an investigational device in the United States and Japan and is not available for sale in those countries, advised Boston Scientific.
In the company’s press release, Prof. Ian Meredith, MD, commented, “The Lotus Edge device is a highly anticipated next generation of the Lotus valve system. It retains many of its predecessor’s unique and valuable proprietary features, including 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 and Depth Guard technology designed to reduce valve interaction with the conduction system of the heart during valve deployment.” Prof. Meredith is Director of MonashHeart, at Monash Medical Center in Melbourne, Australia.