Boston Scientific Lotus™ Valve System demonstrates strong performance
Apr 01, 2014
The Boston Scientific Lotus™ Valve System advanced TAVR technology continued to demonstrate impressive performance at three months, according to new data presented at ACC 2014.
The REPRISE II clinical trial, evaluating the Lotus™ Valve System in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement, demonstrated favorable safety and efficacy outcomes out to three months with 85 percent of patients having no paravalvular aortic regurgitation. 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.
REPRISE II is an ongoing prospective, single-arm study that has enrolled 120 patients at 14 sites in Australia, France, Germany and the U.K. An additional 130 patients will be enrolled in an extension of REPRISE II at 16 sites in Australia and Europe, and enrollment in this extension of REPRISE II is expected to be complete in April 2014.
Key findings from the study include the following:
- At 90 days, an impressive 85.4 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 90 days. There were two cases of moderate paravalvular aortic regurgitation (2.1 percent) and in 12.5 percent of patients, paravalvular regurgitation was considered mild.
- The primary device performance endpoint of 30-day mean aortic valve pressure gradient, as assessed by an independent core laboratory, was met as the 30-day mean aortic valve pressure gradient of 11.5±5.2 mm Hg was significantly (P<0.001) less than the performance goal of 18 mm Hg. At 90 days, the mean aortic valve pressure gradient remained low and stable at 11.5±5.4 mm Hg.
- All-cause mortality at 90 days was 5 percent.
- No instances of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.
- The disabling stroke rate at 90 days was 2.5 percent.
One-year results from REPRISE I, a prospective, single-arm feasibility study of patients with severe symptomatic aortic stenosis conducted in Australia, were presented in May of 2013 at EuroPCR by Professor Meredith and published online ahead of print by EuroIntervention. The data demonstrated sustained safety and performance of the Lotus™ Valve System out to one year with no moderate or severe paravalvular aortic regurgitation in any patient.
About the Lotus™ Valve System
The Lotus™ 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, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant. The device also employs a unique Adaptive Seal™ feature 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 Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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