CE mark for new 25mm Lotus valve system

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Boston Scientific Corporation has received CE mark approval and begun the European commercial launch of its new 25mm Lotus transcatheter aortic valve implantation (TAVI) system, complementing the currently available 23mm and 27mm valve sizes.

“Having the 25mm size allows us to be more precise in selecting the appropriate valve, which we anticipate will further improve outcomes for our patients,” says Nicolas Van Mieghem at Erasmus Medical Center, Rotterdam, The Netherlands.

Prior to full commercialisation, a limited market evaluation of the 25mm valve Lotus valve system was performed in select hospitals across Europe and Australia. Feedback on the valve performance was favourable from all implanting physicians.

“We have seen great results in the patients we have treated with the 25mm Lotus valve system,” says Sabine Bleiziffer from the German Heart Centre in Munich, Germany. “What I really like about the Lotus valve is that it provides a high level of precision during implantation, allowing me to feel in control. We look forward to treating more patients with this valve.”

“The Lotus valve design helps simplify the procedure with the ability to assess valve functionality before release,” says Peter Wenaweser from the Inselspital in Bern, Switzerland. “Adding a 25mm valve makes sizing and valve selection even more precise.”

Six-month outcomes of the REPRISE II clinical study were presented in May at EuroPCR in Paris. REPRISE II is evaluating the Lotus valve system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement. The study demonstrated that the Lotus valve system delivered sustained safety and effectiveness outcomes out to six months, with only 1.1% of patients having moderate paravalvular aortic regurgitation as assessed by an independent core laboratory. No severe cases occurred. 

The Lotus valve system has CE mark approval and is available for sale in CE mark countries. In the USA, the Lotus valve system is not available for sale.