Boston Scientific Receives CE Mark Approval for 25-mm Lotus TAVR System

July 14, 2014—Boston Scientific Corporation announced that it has received European CE Mark approval for the 25-mm Lotus transcatheter aortic valve replacement (TAVR) system. The company has commenced the European commercial launch for the device, which joins the currently available CE Mark-approved 23-mm and 27-mm valve sizes for the Lotus device. The Lotus valve system is not available for sale in the United States.

In Boston Scientific’s press release, Nicolas Van Mieghem, MD, of Erasmus Medical Center in Rotterdam, the Netherlands, stated, “Having the 25-mm size allows us to be more precise in selecting the appropriate valve, which we anticipate will further improve outcomes for our patients.”

The company noted that before full commercialization, it conducted a limited market evaluation of the 25-mm-valve Lotus valve system in select hospitals across Europe and Australia.

Sabine Bleiziffer, MD, commented in the company’s press release, “We have seen great results in the patients we have treated with the 25-mm Lotus valve system. What I really like about the Lotus valve is that it provides a high level of precision during implantation, allowing me to feel in control. We look forward to treating more patients with this valve.” Dr. Bleiziffer is from the German Heart Centre in Munich, Germany. 

Prof. Peter Wenaweser, MD, from the Inselspital in Bern, Switzerland, added, “The Lotus valve design helps simplify the procedure with the ability to assess valve functionality before release. Adding a 25-mm valve makes sizing and valve selection even more precise.”

In May 2014, Boston Scientific announced that 6-month outcomes of the REPRISE II clinical study were presented at the EuroPCR 2014 meeting in Paris, France. REPRISE II is evaluating the Lotus TAVR system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement. The study demonstrated that the Lotus system delivered sustained safety and effectiveness outcomes out to 6 months, with 1.1% of patients having moderate paravalvular aortic regurgitation as assessed by an independent core laboratory and with no occurrence of severe cases. 

According to the company, the Lotus TAVR system is an effective alternative treatment for patients with severe aortic stenosis at high risk of conventional surgical valve replacement. This second-generation TAVR device consists of a preloaded, stent-mounted tissue valve prosthesis and a catheter delivery system for guidance and percutaneous placement of the valve. The low-profile delivery system and introducer sheath enable predictable and precise placement associated with early valve function, as well as bidirectional atraumatic repositioning and retrieval at any time before release of the aortic valve implant.  Rapid pacing is not required. The device also features the company’s Adaptive Seal, which is designed to minimize the incidence of paravalvular regurgitation, a proven predictor of mortality, noted Boston Scientific.