Medtronic Announces Clinical Study to Evaluate the CoreValve(TM) Evolut(TM) PRO System in 'Everyday' Clinical Practice
September 21 2017 - 9:30AM
YASTEST
New Study
Designed to Assess Longer-Term Clinical
Performance of Next-Generation Evolut PRO Transcatheter Aortic
Valve Implantation (TAVI) System
DUBLIN - September 21, 2017 -
Medtronic plc (NYSE: MDT) today announced a new post-market
clinical study to evaluate its CoreValve(TM) Evolut(TM) PRO valve
in everyday clinical practice. Studying patients with severe
symptomatic aortic stenosis at an intermediate, high or extreme
risk for open heart surgery, the FORWARD PRO Clinical Study will
evaluate longer-term performance (out to five years) of the
next-generation self-expanding TAVI system, which was recently
approved for commercial use in Europe and United States.
The Evolut PRO valve - built off the proven Evolut
R platform - is uniquely designed with an outer tissue wrap to
further advance valve sealing performance. The biocompatible
porcine pericardial tissue wrap, in addition to other design
elements, is incorporated to address the occurrence of blood
leaking through the sides of the valve. The first-ever data for
Evolut PRO valve presented at ACC.17 showed no moderate/severe
paravalvular leak (0 percent), high rates of survival (98.3
percent) and a low rate of disabling stroke (1.7 percent) at 30
days.
The multi-center, prospective single-arm study
will enroll 600 patients across 35 sites in Europe, and will
evaluate safety including all-cause mortality and all stroke at 30
days and clinical performance including valve hemodynamics and
paravalvular regurgitation. Patients will be followed out to five
years.
"We look forward to replicating the excellent
clinical outcomes demonstrated by the Evolut PRO valve in a study
designed to look at the valve's longer-term real-world
performance," said Prof. Eberhard Grube, M.D., director of the
Structural Heart Program at University Hospital in Bonn, Germany,
and co-principal investigator of the FORWARD PRO Study. "The Evolut
PRO has shown exceptional results for patients with severe aortic
stenosis and we are excited to enroll our first patients into this
rigorous study."
"As new products are introduced to the global
transcatheter valve market, Medtronic continues to stay focused on
driving meaningful clinical outcomes that matter to patients and
that resonate with physicians," said Pieter Kappetein, M.D., vice
president, medical affairs for Structural Heart business, which is
part of the Cardiac and Vascular Group at Medtronic. "We believe
the improvements made to the self-expanding Evolut TAVI platform
will continue to improve patient outcomes, and we anticipate this
real-world study will demonstrate further evidence of longer-term
performance and safety."
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 84,000 people worldwide, serving physicians,
hospitals and patients in approximately 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
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