Medtronic announced it has received CE mark for its 31mm CoreValve system, the only transcatheter aortic valve available in the world that can treat, without surgery, patients with larger valve openings (up to 29mm). It is the largest transcatheter valve available and, because it can be compressed into a small delivery system, is deployed through the same 18Fr (less than ¼-inch or approximately 6mm in diameter) delivery system as smaller CoreValve sizes.
Medtronic’s CoreValve portfolio now includes 26mm, 29mm and 31mm valves — all based on the self-expanding platform that received CE mark in 2007. Individual sizing is critical to achieving optimal patient blood flow (hemodynamic function) and reducing adverse events, making the availability of an additional size an important offering to physicians and patients.
“The 31mm CoreValve size allows us to provide a lifesaving treatment option for more patients with severe aortic stenosis,” said Ulrich Schäfer, Asklepios Klinik St. Georg Hamburg. “We have seen positive clinical outcomes with the CoreValve system and are pleased to offer it to individuals who, until now, have been denied transcatheter aortic valve implantation due to their larger native valve size.”
The CoreValve System is designed to provide a minimally invasive treatment option — without open-heart surgery — for patients with symptomatic, severe aortic stenosis who are at high risk, or are ineligible, for open-heart surgery.
The Medtronic CoreValve system is currently limited to investigational use in the United States.