Alternative to high risk surgery? New TAVI device approved in Europe

A new transcatheter aortic valve implantation (TAVI) by Boston Scientific has received market approval in Europe.

The device will help treat patients with severe aortic stenosis who are considered at high risk for surgical valve replacement, the company said in a statement. It has been branded the Lotus Edge, part of Boston Scientific’s Lotus Valve System family. It features a more flexible catheter that is easier to implant, making it more conducive for patients wanting to avoid heart surgery.

"The Lotus Edge device is a highly anticipated next generation of the Lotus Valve System," said Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, in a statement. "It retains many of its predecessor's unique and valuable proprietary features, including the ability to reposition the device precisely and prevent paravalvular leak, while incorporating new design characteristics such as a more flexible catheter for easier delivery and Depth Guard™ technology designed to reduce valve interaction with the conduction system of the heart during valve deployment."

The Lotus Edge is still being reviewed for market approval in the U.S. and Japan.

"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," said Kevin Ballinger, president of interventional cardiology at Boston Scientific, in a 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."