Boston Scientific gets CE Mark for new 25mm Lotus valve system

15 July 2014 (Last Updated July 15th, 2014 18:30)

Boston Scientific has secured CE Mark approval and started the European commercial launch of its new 25mm Lotus transcatheter aortic valve implantation (TAVI) system.

Boston Scientific has secured CE Mark approval and started the European commercial launch of its new 25mm Lotus transcatheter aortic valve implantation (TAVI) system.

The new 25mm Lotus TAVI system complements the currently available 23mm and 27mm valve sizes.

Netherlands' Erasmus Medical Center Dr Nicolas van Mieghem said: "Having the 25mm size allows us to be more precise in selecting the appropriate valve, which we anticipate will further improve outcomes for our patients."

The company has carried out a limited market evaluation of the 25mm valve Lotus valve system in select hospitals across Europe and Australia, before fully commercialising the product.

"Having the 25mm size allows us to be more precise in selecting the appropriate valve, which we anticipate will further improve outcomes for our patients."

German Heart Centre Dr Sabine Bleiziffer said: "We have seen great results in the patients we have treated with the 25mm Lotus valve system."

The company has also recently reported six-month data from the REPRISE II clinical trial, which is evaluating the Lotus valve system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.

The REPRISE II trial showed that the 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.

Boston Scientific structural heart vice-president and general manager Tom Fleming said: "Commercialising the 25mm valve only seven months after our initial launch of the Lotus valve system demonstrates our commitment to advancing therapies and improving patient outcomes."

The new Lotus valve system provides an effective alternative treatment for patients with severe aortic stenosis at high risk of conventional surgical valve replacement.

It uses a differentiated second-generation TAVI technology that includes a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve.

The device features a low-profile delivery system and introducer sheath that are designed to provide predictable and precise placement related with early valve function, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant.