Boston Scientific’s Lotus™ TAVI Sees First Commercial Implants in Europe

Last month we noted the CE mark approval of Boston Scientific’s Lotus™ transcatheter heart valve, which was indicated for use in aortic valve patients for whom conventional surgery was a high risk option. Now the first two commercial implants of the Lotus Valve have taken place in a German hospital.

Background

Prof. Dr. med. Gerhard Schuler and Prof. Dr. med. Axel Linke, both considered TAVI pioneers, led the procedures at the Heart Center – University Hospital Leipzig, Germany.

The Lotus Valve System offers a unique and effective alternative treatment for patients with severe aortic stenosis at high risk of surgical valve replacement. It is a next-generation transcatheter aortic valve implantation (TAVI) device designed to give physicians total control throughout the TAVI procedure. 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 minimize aortic regurgitation (leaking), a proven predictor of mortality. 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.

Boston Scientific says its Lotus Valve System is available at select centers in Europe with commercial site expansion accelerating as physicians and centers become fully trained. The valve is available in a 23mm and 27mm size, treating patients with aortic annulus sizes from 20mm to 27mm.

Physician comments

“The Lotus Valve System permits very precise positioning of the device and the Adaptive Seal minimizes potential paravalvular leakage,” said Professor Schuler. “These are the key differentiating features of this new technology.”

“The controlled mechanical expansion and early functioning of the valve facilitate precise positioning on the first attempt, and the ability to fully or partially recapture the valve, if necessary, provides additional assurance that the valve will be ideally positioned at the end of the procedure,” said Dr. Linke.

Company comments

“Completing our first commercial implants marks a key step forward in offering an advanced new technology in Europe. The Lotus Valve System has been designed to give the physician increased control during implantation and to help provide a more precise, predictable procedure,” said Tom Fleming, vice president and general manager, Structural Heart, Boston Scientific. “We believe the Lotus Valve is an important treatment alternative for severe aortic valve disease patients at high risk for surgical valve replacement.” To view and download an image of the Lotus Valve System, click here.

Regulatory status

The Lotus Valve System is an investigational device in the United States and Japan and is not available for sale in these countries.

Source: Boston Scientific, Corp., PR Newswire

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