Boston Scientific has received CE Mark approval for its 25mm Lotus transcatheter aortic valve implantation (TAVI) system in Europe and announced commercial launch of the product in the region.
The company had performed a limited market evaluation of the 25mm valve Lotus valve system across Europe and Australia prior to full commercialization. According to the company, feedback on the valve performance was favorable from all implanting physicians.
In May 2014, Boston Scientific had presented six-month data from the REPRISE II clinical study evaluating the Lotus valve system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.
Data from the REPRISE II study showed that the Lotus valve system delivered sustained safety and effectiveness outcomes out to six months, with only 1.1% of patients having moderate paravalvular aortic regurgitation as assessed by an independent core laboratory, the company claimed.
Boston Scientific Structural Heart vice president and general manager Tom Fleming said that the company believes the addition of the 25mm valve size will offer its Lotus users an important treatment option for patients with severe aortic valve disease.
"Commercializing the 25 mm valve only seven months after our initial launch of the Lotus Valve System demonstrates our commitment to advancing therapies and improving patient outcomes," Fleming added.
The Lotus valve system offers an effective alternative treatment for patients with severe aortic stenosis at high risk of conventional surgical valve replacement. The system has been available in 23mm and 27mm valve sizes in Europe and is not available for sale in the US.
Availability of the valve in three different sizes will allow the physicians to choose precisely based on patients’ anatomy.
Image: Boston Scientific’s Lotus valve system. Photo: Courtesy of Boston Scientific Corporation.