Boston Scientific has announced the first commercial implants of its Lotus valve system, which has recently received the CE mark approval, in the German market.
The first two commercial implants of the new transcatheter aortic valve implantation (TAVI) devices specially designed for total control and accurate deployment have taken place in a German hospital.
Dr Gerhard Schuler and Dr Axel Linke led the procedures at the Heart Centre at University Hospital Leipzig, Germany.
The next-generation TAVI device is designed to offer a unique and effective new treatment alternative for high-risk patients with severe aortic stenosis with surgical valve replacement.
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.
The Reprise II clinical trial data demonstrated that the Lotus valve system was successfully implanted and correctly positioned in all 120 patients, and met the co-primary endpoints of mean aortic valve pressure gradient and all-cause mortality at 30 days.
The implant demonstrated fruitful clinical results, with no valve malpositioning, migration, severe embolisation or low clinical event rates that were consistent with those reported for other valves, and negligible paravalvular aortic regurgitation at 30 days.
Once delivered across the diseased aortic valve, the Lotus valve system is deployed through a controlled mechanical expansion that is distinct from balloon-expandable or self-expanding valves.
The Lotus valve system is available at select centres in Europe, with commercial site expansion accelerating as physicians and centres become fully trained.
The 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.
Boston Scientific structural heart vice-president and general manager, Tom Fleming, said completing company's first commercial implants marks a key step forward in offering an advanced new technology in Europe.
"The Lotus valve system has been designed to give the physician increased control during implantation and to help provide a more precise, predictable procedure," Fleming said.
"We believe the Lotus valve is an important treatment alternative for severe aortic valve disease patients at high risk for surgical valve replacement."
According to GlobalData estimates, the transcatheter heart valves market in Germany was valued at $282m in 2012 and is expected to grow at a CAGR of 12.4%, to reach $639m by 2019.
Image: The Lotus Valve System. Photo: courtesy of Boston Scientific Corporation.