Boston Scientific scored a CE mark for its next-generation transcatheter aortic valve implantation tech. The system is indicated for patients with severe aortic stenosis who are at high risk for surgical valve replacement.
The Lotus Edge Valve System is the company’s follow-up to its Lotus Valve System, which received a CE mark in 2013. Instead of being implanted through open-heart surgery, the Lotus systems allow the replacement valve to be delivered minimally invasively via catheter.
The Lotus Edge has a lower profile and more flexible delivery catheter compared with its predecessor, the company said in a statement. These updates make it easier to use and to navigate twisted blood vessels. The new device also includes a Depth Guard, which is designed to lower the need for a permanent pacemaker, according to the statement.
Lotus Edge is the only TAVI/TAVR device that allows for the repositioning of the valve after it has been deployed and assessed, thanks to its controlled mechanical expansion, Boston Scientific said in the statement.
"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,” said Kevin Ballinger, president of Boston Scientific’s interventional cardiology unit, in the statement.