Boston Scientific Marks First Commercial Use of Lotus TAVR System in Europe

November 15, 2013—Boston Scientific Corporation (Natick, MA) announced the initial commercial implantations of the company's Lotus valve system. Prof. Gerhard Schuler, MD, and Prof. Axel Linke, MD, led the first procedures at the Heart Center–University Hospital Leipzig, Germany.

The company stated that the Lotus valve system is a next-generation transcatheter aortic valve replacement (TAVR) device that is designed as an effective alternative treatment for patients with severe aortic stenosis at high risk of surgical valve replacement. The device is composed of bovine pericardium and a nitinol frame with a central marker to aid in precise positioning. The device features the company's Adaptive Seal technology to help minimize aortic regurgitation. It can be fully retrieved, redeployed, or repositioned, including after full valve deployment and prior to release.

In Boston Scientific's press release, Prof. Schuler commented, “The Lotus valve system permits very precise positioning of the device, and the Adaptive Seal minimizes potential paravalvular leakage. These are the key differentiating features of this new technology.” Prof. Linke added, “The controlled mechanical expansion and early functioning of the valve facilitate precise positioning on the first attempt, and the ability to fully or partially recapture the valve, if necessary, provides additional assurance that the valve will be ideally positioned at the end of the procedure.”

According to the company, the Lotus valve system is available at select centers in Europe, with commercial site expansion accelerating as physicians and centers become fully trained. The Lotus valve is available in 23-mm and 27-mm sizes for treating patients with aortic annulus sizes from 20 mm to 27 mm. The Lotus valve system is an investigational device in the United States and Japan and is not available for sale in these countries.

On October 28, Boston Scientific announced CE Mark approval for the device at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco, California. Also at TCT, the company announced that primary endpoint data from the REPRISE II clinical trial were presented by principal investigator Prof. Ian Meredith, MD, who is director of MonashHeart at Monash Medical Center in Melbourne, Australia.

According to the company, the REPRISE II data demonstrated that the Lotus valve system was successfully implanted and correctly positioned in all 120 patients and met the coprimary endpoints of mean aortic valve pressure gradient and all-cause mortality at 30 days. There was no valve malpositioning, migration, or severe embolization. There were low clinical event rates that were consistent with those reported for other valves and negligible paravalvular aortic regurgitation at 30 days, stated Boston Scientific.