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Boston Scientific Announces Positive Data From Lotus™ Transcatheter Aortic Valve Trial
Date:5/15/2012

CCE includes death, heart attack, major stroke, and conversion to surgery or repeat procedure due to valve-related dysfunction.  All patients had severe symptomatic aortic stenosis and were considered at high risk for surgical valve replacement.  No in-hospital MACCE were reported in 91 percent (10 of the 11) of patients.  One stroke and no deaths were observed.  No moderate or severe paravalvular regurgitation was present after valve placement or at discharge.

The Lotus Aortic Valve System is a differentiated second-generation TAVR technology, which consists 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 REPRISE I results underscore the unique technology behind the Lotus Aortic Valve System, which offers interventional cardiologists greater precision and control in deployment while at the same time minimizing the occurrence of aortic regurgitation. These features help to simplify the implantation procedure, and will potentially lead to improved clinical outcomes," said Keith D. Dawkins, M.D., global chief medical officer for Boston Scientific. "We look forward to advancing the Lotus Aortic Valve System clinical program by initiating patient enrollment in the REPRISE II study later this year."

The REPRISE II trial is designed to evaluate the safety and performance of the Lotus Aortic Valve System in 120 patients at up to 15 sites in Australia and Europe.  Data from the trial are expected to be used to support C
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