Medtronic receives CE Mark for next-generation TAVI system

Medtronic has been granted European CE Mark approval for its new 23 mm CoreValve Evolut R System, for use in transcatheter aortic valve implantation (TAVI) applications.

The novel, self-expanding valve and 14FR equivalent delivery system offers new capabilities that  help to advance valve performance and deliverability during procedures, while also allowing users to recapture and reposition the valve during the deployment phase.

Consisting of the CoreValve Evolut R transcatheter aortic valve and EnVeo R Delivery Catheter System, the platform is designed for first-time positioning accuracy. It also offers a new InLine Sheath that significantly reduces its profile.

The launch will build upon the previous success of the CoreValve System, which has accumulated more than 65,000 implants worldwide to date.

Rhonda Robb, vice-president and general manager for heart-valve therapies at Medtronic, said: "A truly next-generation device, CoreValve Evolut R provides heart teams with meaningful advancements that will increase the potential for optimal device placement."

Last month, the company commenced the largest ever global trial of cardiac resynchronisation therapy in order to investigate the clinical advantages of its AdaptivCRT technology.