Boston Scientific has announced that, following CE mark approval, its Lotus transcatheter aortic valve implantation (TAVI) system has been used for the first time – two patients in Germany were implanted with the device.
According to a company press release, TAVI pioneers Gerhard Schuler and Axel Linke, led the procedures at the Heart Center, University Hospital Leipzig, Germany. Schuler said: “The Lotus valve system permits very precise positioning of the device and the adaptive seal minimises potential paravalvular leakage. These are the key differentiating features of this new technology.”
The press release reports that the Lotus valve is comprised of bovine pericardium and a nitinol frame with a central marker to aid in precise positioning. It features a novel adaptive seal technology to help minimise aortic regurgitation. It is also the first device of its kind that can be fully retrieved, redeployed, or repositioned, including after full valve deployment and prior to release.
The Lotus system is available at select centres in Europe with commercial site expansion accelerating as physicians and centres become fully trained.
The valve is available in a 23mm and 27mm size, treating patients with aortic annulus sizes from 20mm to 27mm. It is an investigational device in the USA and Japan and is not available for sale in these countries.