Lotus Valve system shows benefits in post-market study for aortic valve stenosis- Boston Scientific

A new study evaluating the Boston Scientific Lotus Valve System demonstrated an extremely low rate of paravalvular aortic regurgitation (leakage) for a transcatheter aortic replacement valve, plus a cardiovascular mortality rate of less than two percent at 30 days. In the RESPOND Post-Market Study, more than 95 percent of patients at hospital discharge had no or trace paravalvular aortic regurgitation (PVL), less than 5 percent had mild PVL and no patients exhibited moderate or severe PVL (as assessed by an independent core lab). The cardiovascular mortality rate was 1.6 percent at 30 days, and the mean pressure gradient and effective orifice area, measures used to assess the hemodynamic performance of the valve, were 10.1 +/- 3.7 mmHg and 1.9 cm2 +/- 0.4.

In addition, rates and predictors for PVL were reported from the REPRISE II Extended Cohort, showing nearly 86 percent of patients had either no PVL or trace PVL; less than 14 percent had mild PVL and less than 1 percent had moderate PVL (as assessed by an independent core lab) and no patients had severe PVL. Results were presented at EuroPCR 2015.

Comment: Competition comes from already established Edwards Sapien Heart Valve which is US and EU approved and JenaValve with a CE Mark, as well as Medtronic with its CoreValve. In June 2014 Medtronic secured expanded approval for its CoreValve system for patients at high risk for open heart surgery. At the same time, Edwards Lifesciences got the regulatory green light to launch its Sapien XT device for inoperable patients with severe aortic stenosis in the US.