US-based Boston Scientific has obtained CE Mark for the Lotus valve system, designed to offer a unique and effective new treatment alternative for patients with severe aortic stenosis at high-risk with surgical valve replacement.
With this approval, the new advanced transcatheter aortic valve replacement (TAVR) technology is immediately available to select centres in Europe, with commercial site expansion accelerating as physicians and centres become fully trained.
The Lotus valve system consists of a pre-loaded, stent-mounted tissue valve prosthesis and catheter delivery system for guidance and percutaneous placement of the valve.
The low-profile delivery system and introducer sheath are designed to enable predictable and precise placement, as well as bi-directional atraumatic repositioning and retrieval at any time prior to release of the aortic valve implant.
It also employs a unique Adaptive Seal technology that helps minimise aortic regurgitation, a proven predictor of mortality.
In addition to offering precise positioning and placement option to physicians, the Lotus Valve System is believed to have the potential to improve clinical outcomes by minimising paravalvular leaks.
Monash Medical Centre in Melbourne director of MonashHeart and principal investigator of the REPRISE II trial professor Ian Meredith said: "Combined with early and often complete elimination of aortic regurgitation as observed in REPRISE II, the unique features of the Lotus Valve technology represent a significant step forward in the percutaneous treatment of eligible patients with severe symptomatic aortic stenosis."
The six-month results unveiled during PCR London Valves in September also reported the Lotus valve system met the primary performance endpoint for the first 60-patient cohort and was implanted successfully in all patients (60/60) with no cases of severe paravalvular regurgitation.
A total 76.1% of patients experienced no corelab adjudicated paravalvular regurgitation at six months.
Boston Scientific Structural Heart vice-president Tom Fleming said: "It's the culmination of a decade of research and development and demonstrates our commitment to innovations that make a difference in the lives of patients."
The Lotus valve system is available in a 23mm and 27mm size, and can treat patients with aortic annulus sizes from 20mm to 27mm.
According to the company, the Lotus valve system is an investigational device in the US and Japan and is not available for sale in these countries.
It was developed by Sadra Medical, which was acquired by Boston Scientific in 2011.
According to GlobalData estimates, the transcatheter heart valves market in Europe was valued at $648m in 2012 and is expected to grow at a CAGR of 18.5% to reach $2.12bn by 2019.
Image: The Lotus Valve System. Photo: courtesy of Boston Scientific Corporation.