Medtronic has received European approval to market the company’s CoreValve transcatheter aortic valve replacement system for delivery via the subclavian approach.
Since 2007, the Medtronic CoreValve System has been implanted in more than 12,000 people in 34 countries. The Medtronic CoreValve System is currently limited to investigational use in the United States.
“The subclavian approach will give physicians expanded access to care for a significant underserved subset of patients for whom femoral delivery is not possible or desirable. Given the sheer number of patients with severe aortic stenosis along with the aging population, the need for new approaches to valve replacement continues to increase,” said Neil Moat, M.B.B.S., M.S., F.R.C.S. and consultant cardiac surgeon at The Royal Brompton Hospital in London.
Medtronic will begin training physicians on the subclavian technique in the coming weeks.
Press release: Medtronic CoreValve® System Gains CE Mark for New Subclavian Approach to Transcatheter Aortic Valve Implantation …
Product page: CoreValve…
Flashbacks: Medtronic’s CoreValve Transcatheter Aortic Valve Replacement System Performs Well in Trial ; Medtronic’s CoreValve Clinical Trial Receives FDA Approval; CoreValve Aortic Valve Replacement System Now With AccuTrak Stability Layer