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Next-generation TAVR system receives CE mark
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Boston Scientific announced its next-generation transcatheter aortic valve replacement system has received a CE mark and can now be used in Europe in patients with severe aortic stenosis at high risk for surgery.
The system (Lotus Edge, Boston Scientific) is more flexible and has a lower profile design compared to the previous iteration, according to a press release from the company.
The system also includes a feature (Depth Guard) intended to reduce the need for a permanent pacemaker, and a technology (Adaptive Seal) designed to minimize paravalvular leak, the company stated in the release.
“The Lotus Edge device is a highly anticipated next generation of the Lotus Valve System," Ian Meredith, MBBS, PhD, FACC, FCSANZ, FSCAI, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, said in the release. "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.”
The device is not currently available in the United States.
Disclosure: Meredith reports consulting for Boston Scientific.