Boston Scientific has secured CE mark approval for its Lotus Edge valve system, which is indicated to replace aortic valve in patients with serious aortic stenosis who are considered at high risk for surgical valve replacement.
The system, which the company's next generation transcatheter aortic valve implantation (TAVI) technology, helps to avoid the open heart surgery. It will be placed through transcatheter percutaneous delivery.
The deliver process is a minimally invasive procedure involving a small incision to gain access to a blood vessel.
The system features a lower profile catheter that will accommodate tortuous anatomy, as well as Depth Guard that will reduce the need for a permanent pacemaker (PPM).
It also incorporates Adaptive Seal technology, which minimizes paravalvular regurgitation (leaking) or PVL.
The system is an investigational device in the US and Japan and is not available for sale in those countries, the company said.
Boston Scientific interventional cardiology president Kevin Ballinger said: "We are steadfast in our commitment to advancing the science behind TAVI procedures by ensuring clinicians have effective treatment modalities to provide to their patients with severe aortic stenosis.
"The Lotus Edge valve system is designed to give physicians increased control during implantation, which can help provide a more precise, predictable procedure to ensure the best patient outcomes."