Medtronic Expands Heart Valve Portfolio with FDA Approval and CE Mark of the Avalus(TM) Surgical Aortic Valve
(Thomson Reuters ONE) -
Introduction of New Pericardial Aortic Heart Valve in the U.S. and Europe
Reinforces Company's Commitment to Comprehensive Solutions to Heart Valve
Disease
DUBLIN - August 2, 2017 - Medtronic plc (NYSE: MDT) today announced CE
(Conformité Européenne) mark and U.S. Food and Drug Administration (FDA)
approval of its new Avalus(TM) pericardial aortic surgical valve for the
treatment of aortic valve disease. The Avalus valve leverages proven surgical
bioprosthetic valve concepts with added features designed to enhance clinical
performance, helping to address the contemporary needs of cardiac surgeons, as
well as patients who are candidates for aortic valve replacement. The Avalus
valve is the latest addition to Medtronic's robust portfolio of innovative heart
valve therapy solutions. In addition to being the only stented surgical aortic
valve on the market that is MRI-safe (without restrictions), the Avalus valve is
designed for excellent implantability, an important factor during complex cases.
"The proven design elements of the Avalus valve were selected with physicians
and patients in mind striving to improve upon the latest generation of stented
tissue valves while maintaining the gold standard in cardiac surgery," said
Robert Klautz, M.D., cardiac surgeon and department head of cardiothoracic
surgery at the Leiden University Medical Center in The Netherlands. Prof. Klautz
is also the co-primary investigator of the PERIGON trial, evaluating the safety
and efficacy of the Avalus valve. "Based on my early clinical experience, the
unique design elements of the Avalus valve position it well toward meeting the
expectations of durability for new tissue valves and helps ease implantation in
a wide range of patient anatomies."
The Avalus valve represents the next generation in pericardial aortic surgical
valves for patients who are candidates for surgery. The Avalus valve features
several significant developments, including:
* a supra-annular design for excellent hemodynamic performance, intended to
limit central regurgitation.
* Interior-mounted leaflet and frame design to enhance durability.
* a low-profile valve design, streamlined valve holder and a single, one-cut
release to facilitate ease of implantation.
"Medtronic is committed to advancing its surgical portfolio to offer cardiac
surgeons a contemporary option to help meet the individual needs of this patient
population," said Rhonda Robb, vice president and general manager of the Heart
Valve Therapies business, a part of Medtronic's Cardiac and Vascular Group. "By
continuing to collaborate with leading cardiac surgeons around the world, we
look forward to bringing heart valve replacement solutions like the Avalus valve
to assist in expanding access and improving outcomes for clinical and patient
communities."
The CE Mark and FDA approval of the Avalus valve is based on subsets of data
from the PERIGON Pivotal Trial, a single arm, non-randomized, prospective study
of more than 1,100 patients from approximately 40 clinical sites across Europe,
Canada and the United States. One of the largest, most comprehensive and modern
data sets of surgical aortic valve replacement (SAVR) patients, results from the
trial were recently presented by Dr. Joseph Sabik of the UH Cleveland Medical
Center at the American Association of Thoracic Surgery (AATS) annual meeting in
Boston, and showed low rates of adverse valve-related events, high survival and
improved hemodynamic performance at one year. Patients enrolled in the trial
will be followed out to five years. The Avalus valve will be commercially
available later this year.
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. The company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers around the
world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among
the world's largest medical technology, services and solutions companies -
alleviating pain, restoring health and extending life for millions of people
around the world. Medtronic employs more than 91,000 people worldwide, serving
physicians, hospitals and patients in more than 160 countries. The company is
focused on collaborating with stakeholders around the world to take healthcare
Further, Together.
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:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 02.08.2017 - 16:00 Uhr
Sprache: Deutsch
News-ID 555073
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