Boston Scientific’s 25 mm Lotus TAVI Earns CE Mark

Boston Scientific Corporation’s 25 mm Lotus Transcatheter Aortic Valve Implantation (TAVI) System received a CE mark and will be launched in Europe, supplementing the devicemaker’s existing 23 mm and 27 mm valve sizes.

Data from the REPRISE II clinical study — evaluating the system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement — showed the Lotus Valve System delivered sustained safety and effectiveness outcomes out to six months, the company said.

The system consists of a preloaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve, according to the devicemaker. It has a low-profile delivery system and an introducer sheath that facilitates placement, repositioning and retrieval at any time prior to release of the implant, the company added.

“The 25 mm size allows us to be more precise in selecting the appropriate valve, which we anticipate will further improve outcomes for our patients," said Nicolas Van Mieghem, a surgeon at Erasmus Medical Center in The Netherlands, who participated in a small market evaluation of the device.

The Lotus Valve System is not yet available in the U.S. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.