THE LOTUS VALVE SYSTEM BY BOSTON SCIENTIFIC CORPORATION

An ongoing study of patients with severe symptomatic aortic stenosis

Boston Scientific Corporation announced, at PCR London Valves, encouraging clinical signs for 60 patients undergoing the REPRISE II clinical trial. The purpose of the 6-month experimentation was to measure the safety and performance of the Lotus Valve System, in patients dealing with severe aortic stenosis and thought to be at high risk for surgical valve replacement. 120 patients at 14 sites in Australia, France, Germany and the United Kingdom were registered in the REPRISE II study.

Particularly impressive clinical outcomes were shown with no new valve-related adverse cases, during a period of 30 days to six months. In addition, no events of average nor severe paravalvular regurgitation was experienced by any patient at six months.

Scientists place high hopes in the development of the Lotus Valve System as it remains the first transcatheter aortic valve replacement (TAVR) device available with an Adaptive Seal. The purpose of the transferable and retrievable seal is to reduce aortic regurgitation around the valve and consequently mortality.

More trials and data collecting are required before a potential commercialisation of the Lotus Valve System but REPRISE II opens the door to new implantation process and may change the face of treatment for patients with severe aortic valve disease.