Boston Scientific's Lotus TAVR System Receives CE Mark Approval

October 28, 2013—Boston Scientific Corporation (Natick, MA) announced European CE Mark approval for the Lotus valve system for transcatheter aortic valve replacement (TAVR) as a treatment alternative for patients with severe aortic stenosis at high risk for surgical valve replacement. The Lotus valve system is immediately available to select centers in Europe, with commercial site expansion accelerating as physicians and centers become fully trained.

According to Boston Scientific, the Lotus TAVR device is designed to provide physicians increased control during implantation and to help provide a more precise, predictable procedure. A key feature of the device is that it can be assessed in its final position before release, while maintaining the ability for the physician to reposition or fully resheath and retrieve the valve. The Lotus system also incorporates the company's Adaptive Seal technology, which is designed to minimize aortic regurgitation.

The Lotus valve system is preloaded on a transfemoral delivery system. It is available in 23 and 27 mm sizes to treat patients with aortic annulus sizes from 20 to 27 mm. The Lotus valve system is an investigational device in the United States and Japan and is not available for sale in those countries, advised the company.

Boston Scientific's REPRISE clinical trial program is intended to support Boston Scientific's application for CE Mark and other international regulatory approvals. Prof. Ian T. Meredith, MD, served as principal investigator of the REPRISE II trial. Prof. Meredith is director of MonashHeart at Monash Medical Centre in Melbourne, Australia.

In the company's press release, Prof. Meredith commented, “The ability to initially position the Lotus valve precisely and, if needed, to easily reposition or fully retrieve the valve provides the operator with remarkable control. Combined with early and often complete elimination of aortic regurgitation as observed in REPRISE II, the unique features of the Lotus valve technology represent a significant step forward in the percutaneous treatment of eligible patientswith severe symptomatic aortic stenosis.”

Boston Scientific advised that the REPRISE II data demonstrated that the Lotus valve system met the primary performance endpoint for the first 60-patient cohort and was implanted successfully in all patients (60/60) with no cases of severe paravalvular regurgitation. In 76.1% of patients, there was no core lab–adjudicated paravalvular regurgitation at 6 months. The REPRISE II data were presented at the PCR London Valves course in September 2013.

Also in the company's press release, Nicolas M. Van Mieghem, MD, of Erasmus Medical Center in Rotterdam, the Netherlands, commented, “Results from the REPRISE II trial highlight the promise behind the Lotus valve system, especially related to avoiding moderate or severe paravalvular leaks. In addition to providing a new treatment option for TAVR, the Lotus valve has the potential to improve clinical outcomes by minimizing paravalvular leaks.”