Boston Scientific Lotus™ Valve System demonstrates strong performance and safety profile at six months
May 21, 2014
Only 1.1 Percent of Patients Experienced Moderate Paravalvular Aortic Regurgitation; No Severe Cases Occurred
Further validating its advanced transcatheter aortic valve implantation (TAVI) technology, the Boston Scientific Corporation (NYSE: BSX) Lotus™ Valve System continued to demonstrate impressive performance at six months, according to new data presented at EuroPCR 2014 in Paris.
Results from the REPRISE II clinical trial demonstrated that the Lotus Valve System delivered sustained safety and effectiveness outcomes out to six months, with only 1.1 percent of patients having moderate paravalvular aortic regurgitation (leaking). No severe cases occurred. The data were presented by Professor Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. The study is evaluating the Lotus Valve System in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.
In REPRISE II, the key six-month findings include the following:
- The primary device performance endpoint of 30-day mean aortic valve pressure gradient, as assessed by an independent core lab, was met as the 30-day mean aortic valve pressure gradient of 11.5±5.2mmHg was significantly less than the performance goal of 18 mmHg (P<0.001). At six months, the mean aortic valve pressure gradient remained low and stable at 11.4±4.6 mmHg.
- An impressive 79.8 percent of patients had no paravalvular aortic regurgitation by independent core lab assessment. In addition, no cases of severe paravalvular aortic regurgitation occurred in any patient at six months.
- The all-cause mortality rate was 8.4 percent.
- The 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.
"These new results from the REPRISE II clinical trial program underscore the unique technology behind the Lotus Valve System," said Keith Dawkins, M.D., global chief medical officer, Boston Scientific. "These features are designed to provide a predictable implantation procedure and may result in improved clinical outcomes. The Lotus Valve offers a novel TAVI option for patients with severe aortic valve disease considered at high risk for surgical valve replacement."
REPRISE II is an ongoing prospective, single-arm study that enrolled 120 patients at 14 sites in Australia, France, Germany and the UK. The trial was extended to an additional 130 patients at 16 sites in Australia and Europe. Enrollment in this extension of REPRISE II is now complete.
About the Lotus Valve System
The Lotus Aortic Valve System is a differentiated second-generation TAVR technology, consisting of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve. The low-profile delivery system and introducer sheath are designed to enable predictable and precise placement associated with early valve function, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant. The device also features a unique Adaptive Seal™ designed to minimize the incidence of paravalvular regurgitation, which has proven to be a predictor of mortality. The Lotus Valve System has CE Mark approval and is available for sale in CE Mark countries. In the U.S., the Lotus Valve System is an investigational device and not available for sale.
About Aortic Valve Disease
Aortic valve disease results in dysfunction of the aortic valve, one of the four valves that control the flow of blood in and out of the heart. Aortic valve stenosis is the process of thickening and stiffening in the valve, which can result in an abnormal narrowing of the aortic valve opening and reduction in blood flow. Aortic stenosis is a common problem affecting approximately three percent of the population over age 65 and five percent of people older than 75. From the onset of aortic stenosis symptoms, the average survival rate is 50 percent at two years and 20 percent at five years.
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