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.
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Contacts:
Kathleen Janasz
Public Relations
+1-763-526-3676
Jeff Warren
Investor Relations
+1-763-505-2696
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Source: Medtronic, Inc. via Thomson Reuters ONE
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