Boston Scientific Gets Expanded CE Mark for Lotus TAVR Valve

Boston Scientific Corp. received European CE mark for the 25-millimeter Lotus transcatheter aortic valve replacement (TAVR) system. The company has commenced the European commercial launch for the device, which joins the 23- and 27-millimeter Lotus valves currently on the market in Europe. The Lotus valve system is not available for sale in the United States. Right now, Edwards Lifesciences Corp. and Medtronic Inc. are the only companies with U.S.-approved TAVR devices.

“Having the 25-millimeter size allows us to be more precise in selecting the appropriate valve, which we anticipate will further improve outcomes for our patients,” said Nicolas Van Mieghem, M.D., of Erasmus Medical Center in Rotterdam, the Netherlands

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

“We have seen great results in the patients we have treated with the 25-millimeter Lotus valve system,” said Sabine Bleiziffer, M.D., of the German Heart Centre in Munich, Germany. “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.”

In May, Boston Scientific presented six-month outcomes of the REPRISE II clinical study 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 six months, with 1.1 percent of patients having moderate paravalvular aortic regurgitation as assessed by an independent core laboratory and with no occurrence of severe cases, the company reported.

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. 

The device also features the company’s Adaptive Seal technology, which is designed to minimize the incidence of paravalvular regurgitation, a proven predictor of mortality, noted Boston Scientific officials.

The company recently moved into its new headquarters in Marlborough, Mass.