Approval is Expected to Expand Access to Care for Patients with Severe Aortic Stenosis
MINNEAPOLIS--(BUSINESS WIRE)-- Medtronic, Inc. (NYSE: MDT) has received CE (Conformité Européenne) Mark for the Medtronic CoreValve® System to be delivered through a novel approach, which would allow access through the subclavian artery located beneath the collar bone. As a result, thousands more patients in Europe with severe aortic stenosis may be eligible to receive transcatheter aortic valve implantation (TAVI). 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 CoreValve System is designed to provide a non-surgical aortic valve replacement option for patients with severe aortic stenosis who are at high or prohibitive risk for open-heart surgery. Transcatheter valves are typically implanted through the femoral artery in the leg. However, there are thousands of people whose femoral arteries are too narrow or are compromised due to disease.
“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.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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