Medtronic, Inc. : Medtronic Announces CE Mark for Engager(TM) Transcatheter
New Valve Provides Transapical Option for Physicians Treating Patients with
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.
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
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Source: Medtronic, Inc. via Thomson Reuters ONE
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