News | December 10, 2010

Transcatheter Aortic Valve Gains CE Mark for Subclavian Access

December 10, 2010 – European CE mark approval has been granted so the Medtronic CoreValve transcatheter aortic valve replacement system can be delivered through the subclavian artery, located beneath the collar bone.

As a result of this new vascular access point, thousands more patients in Europe with severe aortic stenosis may be eligible to receive transcatheter aortic valve implantation (TAVI). Since 2007, the CoreValve system has been implanted in more than 12,000 people in 34 countries. It was previously only available through femoral access delivery.

The CoreValve System is designed to provide a nonsurgical 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, MBBS, MS, FRCS and consultant cardiac surgeon at The Royal Brompton Hospital in London.

Medtronic will begin training physicians on the subclavian technique in the coming weeks.

The valve is currently limited to investigational use in the United States.

For more information: www.medtronic.com

Related Content

Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
The ChordArt transcatheter mitral valve leaflet chord replacement system on X-ray, showing the anchoring sections of the artificial chord.

The ChordArt transcatheter mitral valve leaflet chord replacement system on X-ray, showing the anchoring sections of the artificial chord.

News | Heart Valve Technology| August 01, 2017
Aug.
Hitachi and West Virginia University Partner to Advance Left Ventricular Mechanical Function Evaluation
News | Cardiovascular Ultrasound| July 21, 2017
Hitachi Healthcare and the West Virginia University Heart and Vascular Institute announced the formation of a new...
Edwards Sapien 3 TAVR valve will be implanted in asymptomatic aortic stenosis patients in the EARLY TAVR Trial
Feature | Heart Valve Technology| July 14, 2017
July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, has randomized the first patient in the wo
Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve

An example of Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve.

Technology | Computed Tomography (CT)| July 12, 2017
July 12, 2017 — At the 2017 annual meeting for the Society of Cardiovascular Computed Tomography (SCCT), Ziosoft show
Medtronic's CoreValve Evolut R gained FDA approval for intermediate risk patients

An illustration of the self-expanding CoreValve Evolut R TAVR valve half deployed in the aortic root.

Feature | Heart Valve Technology| July 10, 2017
The U.S. Food and Drug Administration (FDA) has cleared an additional indication to expand the use Medtronic's self-...
HAART 300 Aortic Annuloplasty Device Sees U.S. Pilot Launch, First Commercial Use
News | Annuloplasty Rings| July 05, 2017
July 5, 2017 — BioStable Science & Engineering Inc.
Novel Approach May Improve Valve Function in Some Patients

Image courtesy of Messas, et al. JACC Basic to Translational Medicine.

News | Heart Valve Technology| June 30, 2017
June 30, 2017 — Pulsed cavitation ultrasound can be used to remotely soften human degenerative calcified biosprosthet
Overlay Init