Image courtesy of Boston Scientific
January 2, 2015 — New data from the Boston Scientific clinical trial program of the Lotus Valve System continue to demonstrate strong performance as a less invasive treatment for patients with severe aortic stenosis who are considered high risk for surgical valve replacement.
Data from the REPRISE II clinical trial confirmed safety and effectiveness out to one year, with more than 86 percent of patients exhibiting a complete absence of paravalvular aortic regurgitation (leaking) and no patients demonstrating moderate or severe paravalvular aortic regurgitation. New data from the REPRISE I and REPRISE II clinical trials were presented at the 26th Transcatheter Cardiovascular Therapeutics (TCT) meeting.
REPRISE II is an ongoing prospective, single-arm, multi-center study designed to evaluate safety and performance of the Lotus Valve System for symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement. The study enrolled 120 patients at 14 sites in Australia, France, Germany and the U.K.
In REPRISE II, key one-year results include the following:
- Mean aortic valve pressure gradient remained low and stable at 12.6 + 5.7 mmHg.
- More than 86 percent of patients had no paravalvular aortic regurgitation by independent core lab assessment. In addition, no cases of moderate or severe paravalvular aortic regurgitation occurred. Mild and trace paravalvular aortic regurgitation rates were low at 11.4 and 2.3 percent, respectively.
- Cardiovascular mortality rate was 6.7 percent.
- Disabling stroke rate was 3.4 percent.
- No cases of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.
"The one-year REPRISE II data show strong and sustained clinical benefits, excellent valve hemodynamics and remarkably low rates of paravalvular regurgitation and cardiovascular mortality," said Ian Meredith, Ph.D., director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. "These positive data reinforce the benefits and features of the Lotus Valve System including the ability to achieve precise primary valve placement, reposition or fully retrieve if needed, and minimize if not obliterate paravalvular regurgitation with an effective Adaptive Seal."
For more information: www.bostonscientific.com