Boston Scientific Reports Favorable Six-Month Results From Lotus™ Valve System Clinical Trial
Sep 17, 2013
REPRISE II Data Honored as Best Abstract 2013 at PCR London Valves Course
Boston Scientific Corporation (NYSE: BSX) reported favorable six-month results from the first 60 patients enrolled in the REPRISE II clinical trial evaluating the safety and performance of the Lotus™ Valve System in symptomatic patients with severe aortic stenosis considered at high risk for surgical valve replacement.
The data, which were presented today at PCR London Valves and formally received the honor of Best Abstract 2013, demonstrated excellent results with no new valve-related adverse events between 30 days and six months. Additionally, there were no cases of moderate or severe paravalvular regurgitation in any patient at six months.
- Excellent hemodynamic results continue to be observed at six months as demonstrated by mean aortic valve pressure gradient of 12.1 ± 5.0 mmHg and mean aortic valve area of 1.8 ± 0.5 cm2.
- Independent core lab assessment of paravalvular aortic regurgitation showed 76.1 percent of patients presenting with no paravalvular regurgitation and no cases of moderate or severe regurgitation.
- There were no new valve-related adverse events recorded between 30 days and six months.
- The NYHA classification data demonstrated a significant improvement in heart failure symptoms at six months compared to baseline.
"The Lotus Valve System provides the operator with superb control allowing precise positioning and accurate deployment," said Professor Ian Meredith, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. "The results from the first 60 patients of the REPRISE II trial are very impressive, especially with no patients presenting with moderate or severe paravalvular regurgitation at six months."
The Lotus Valve System is the first transcatheter aortic valve replacement (TAVR) device of its kind with an Adaptive™ Seal that is designed to minimize aortic regurgitation (leaking) around the valve, a proven predictor of mortality, and is both fully repositionable and retrievable prior to release.
Boston Scientific expects to release additional REPRISE II data in late October at the TCT (Transcatheter Cardiovascular Therapeutics) conference in San Francisco.
"The latest results from REPRISE II underscore the promising and unique technology behind the Lotus Valve System, demonstrating how the Lotus Valve System can offer a new treatment alternative for patients with severe aortic valve disease," said Keith Dawkins, M.D., global chief medical officer, Boston Scientific. "These features help to simplify the implantation procedure and may lead to improved clinical outcomes."
The results of the REPRISE clinical trial program are expected to be used to support CE Mark and other international regulatory approvals.
About REPRISE II
REPRISE II is an ongoing prospective, single-arm study that has completed enrollment of 120 patients at 14 sites in Australia, France, Germany and the United Kingdom. All patients had severe symptomatic aortic stenosis and were considered at high risk for surgical valve replacement. An additional 130 patients are expected to be enrolled at a total of 20 sites in Australia and Europe in an extension of REPRISE II.
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