Boston Scientific Commences REPRISE II Study of Lotus Valve System

October 10, 2012—Boston Scientific Corporation (Natick, MA) announced the enrollment of the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus valve system in patients with severe aortic valve disease.

The international, multicenter study will enroll up to 120 patients at 15 sites in Australia, France, Germany, and the United Kingdom. REPRISE II is designed to study two valve sizes, 23 mm and 27 mm. The study will have a 5-year follow-up, and beyond that, it will assess for other endpoints recommended by the Valve Academic Research Consortium and regulatory agencies.

The company advised that current study enrollment requires patients to have severe calcific aortic stenosis, be 70 years of age or older, and be considered at high surgical risk as defined by a Society of Thoracic Surgeons mortality score > 8 or by the consensus opinion of the heart team. The company expects that the REPRISE II study enrollment will be completed in the first half of 2013 and that the results will be used to support CE Mark approval and other international regulatory approvals.

According to Boston Scientific, the Lotus valve system is a differentiated second-generation transcatheter aortic valve replacement technology that is designed to minimize aortic regurgitation. It is an investigational device, limited by applicable law to investigational use and not available for sale. The device was developed by Sadra Medical, Inc. (Los Gatos, CA), which Boston Scientific acquired in 2011.

The company stated that the device is both fully repositionable and retrievable before release, thereby offering predictable and precise placement. It consists of a preloaded, stent-mounted tissue valve prosthesis and catheter delivery system used 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 bidirectional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant. The device's Adaptive Seal feature is designed to minimize the incidence of paravalvular regurgitation, which has proven to be a predictor of mortality.

“We were encouraged by the promising results of the REPRISE I clinical trial completed earlier this year, and we are therefore very confident about evaluating the safety and performance of the Lotus calve in a larger patient cohort,” commented Professor Ian Meredith, MD, of the Monash Medical Centre in Melbourne, Australia. Professor Meredith, who is the Principal Investigator of the REPRISE II trial, added, “The Lotus valve has a number of important features which address some of the limitations observed with the first-generation devices. The ease of use, predictable and precise positioning, and the ability to fully reposition and retrieve the Lotus valve offer the operator considerable reassurance and control. These features, along with the minimized risk of paravalvular leakage, may lead to improved clinical outcomes.”