Boston Scientific's Lotus TAVR gains CE mark

Boston Scientific announced Monday that it received CE mark for the Lotus Valve System, the transcatheter aortic valve replacement (TAVR) technology, offering a new treatment alternative for patients with severe aortic stenosis at high risk with surgical valve replacement. "The Lotus Valve System offers patients a new, effective treatment option and provides physicians unmatched positioning and placement capabilities," said Tom Fleming, vice president and general manager of structural heart.

A pre-specified analysis of the ongoing REPRISE II study, which was presented in May at the EuroPCR meeting, showed that the device met the primary performance endpoint, in the first cohort of 60 patients, and had been implanted successfully in all subjects with no cases of severe paravalvular regurgitation. Boston Scientific also recently reported that the device demonstrated "excellent" follow-up results in the same cohort, who exhibited no new valve-related adverse events between 30 days and six months.

According to the device maker, the system, which features Adaptive Seal technology designed to minimise aortic regurgitation, "is the only aortic valve device that can be assessed in its final position prior to release, while maintaining the ability for the physician to reposition or fully resheath and retrieve the valve." Ian Meredith, principal investigator of the REPRISE II trial, remarked that "combined with early and often complete elimination of aortic regurgitation as observed in REPRISE II, the unique features of the Lotus Valve technology represent a significant step forward in the percutaneous treatment of eligible patients with severe symptomatic aortic stenosis."

Boston Scientific noted that the device will be available immediately at select centres in Europe, with commercial site expansion accelerating as doctors become fully trained.

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