Boston Scientific reports positive Lotus Valve System trial data

Boston Scientific has announced positive clinical trial data for its Lotus Valve System, further validating the benefits of the advanced transcatheter aortic valve implantation (TAVI) technology.

Results from the Reprise II study revealed that Lotus was able to deliver sustained safety and efficacy outcomes after six months, with only 1.1 percent of patients experiencing moderate paravalvular aortic regurgitation and no severe cases occuring.

The trial was originally designed as an ongoing prospective, single-arm study that enrolled 120 patients at 14 sites in Australia, France, Germany and the UK, but it has since been extended to an additional 130 patients at 16 sites in Australia and Europe.

Lotus has already received CE Mark approval and is available for sale in Europe, but is yet to be approved and commercialised in the US.

Dr Keith Dawkins, global chief medical officer at Boston Scientific, said: "The Lotus Valve offers a novel TAVI option for patients with severe aortic valve disease considered at high risk for surgical valve replacement."

This comes after the firm previously announced positive data from a trial showing the healthcare benefits associated with its Latitude remote patient management system earlier this month.