Free Submission Public Relations & NewsPR-inside.com
Home
Deutsch English

Business

Medtronic Announces CE Mark for Engager(TM) Transcatheter Valve


Print article Print article
Copyright © Thomson Reuters 2013. All rights reserved.
2013-02-28 15:07:23 -

New Valve Provides Transapical Option for Physicians Treating Patients with
                                Aortic Stenosis

MINNEAPOLIS - February 28, 2013 - Medtronic, Inc. (NYSE: MDT) today announced CE
(Conformité Européenne) Mark of the Engager Transcatheter Aortic Valve
Implantation (TAVI) System with transapical delivery catheter to treat patients
with severe aortic stenosis who are at high or extreme risk for surgical aortic
valve replacement (SAVR).

The new valve demonstrated positive clinical outcomes in its European Pivotal
Trial. Results from the multi-center trial, which were presented during late-
breaking trial sessions at the recent European Association for Cardio-Thoracic
Surgery and the Society of 
Thoracic Surgeons annual meetings, revealed high rates of procedural success, minimal paravalvular leak (PVL) and continuing clinical benefits for patients over time. In the Trial, the Engager valve was delivered transapically and had 94.3 percent overall device success (according to Valve Academic Research Consortium modified definitions). There were no procedures requiring a second valve and no occurrences of valve embolization, coronary obstruction or device malposition. No patients had moderate or severe PVL at six months, as measured by an independent echocardiography core lab. In addition, while most patients (88 percent) were NYHA Class III or IV at baseline, at six months 82 percent of patients had improved to NYHA Class I or II. "The Engager valve has demonstrated exceptional clinical results, and by adding it to our transcatheter valve portfolio, we are providing heart teams with more options for achieving the best outcomes for every patient with severe aortic stenosis," said John Liddicoat, M.D., senior vice president of Medtronic and president of the Medtronic Structural Heart Business. The Medtronic Engager System is not available in the United States. The Engager valve uses a minimally-invasive delivery system via a catheter inserted in the apex (the lower, pointed end) of the heart. The valve is comprised of bovine tissue leaflets and a self-expanding nitinol frame designed to promote annular sealing to minimize paravalvular leak. Control arms simplify implantation, and the supra-annular valve positioning facilitates leaflet coaptation (connections) in non-circular anatomy for optimal hemodynamic performance. A direct aortic delivery system for Engager will be introduced in the future. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. About Medtronic 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. - end - Contacts: Kathleen Janasz Public Relations +1-763-526-3676 Jeff Warren Investor Relations +1-763-505-2696 This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Medtronic, Inc. via Thomson Reuters ONE [HUG#1681821]


Press Information:




Contact Person:


Disclaimer: © 2014 Thomson Reuters. The press releases or report contained herein is protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Thomson Reuters's, who warrant that they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction, other than for an individual user's personal reference, is prohibited without prior written permission.
Latest News
Read the Latest News
www.newsenvoy.com

 


Terms & Conditions | Privacy | About us | Contact PR-inside.com