Medtronic Receives FDA Approval for CoreValve(TM) Evolut(TM) Pro Transcatheter Valve with Advanced Sealing
March 22 2017 - 9:00AM
First-Ever Data at
ACC.17 Confirms Safety and Efficacy of New Self-Expanding,
Recapturable Heart Valve at 30-Days with High Survival, Low Stroke
and Minimal Paravalvular Leak
DUBLIN - March 22, 2017
- Medtronic plc (NYSE:MDT) today announced
U.S. Food and Drug Administration (FDA) approval and U.S. launch of
the CoreValve(TM)
Evolut(TM) PRO valve
for the treatment of severe aortic stenosis for symptomatic
patients who are at high or extreme risk for open heart surgery.
The approval comes on the heels of new 30-day clinical data that
was unveiled at the American College of Cardiology (ACC) 66th
Annual Scientific Session, which showed high survival, low rates of
stroke, minimal paravalvular leak (PVL) and excellent hemodynamics
for the self-expanding valve.
The Evolut PRO device features a unique valve
design with an outer wrap that adds surface area contact between
the valve and the native aortic annulus 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.
"Based on my experience implanting the Evolut PRO
valve during the clinical study, I've been impressed by the
clinical outcomes achieved in our patients," said Mathew Williams,
M.D., chief of Adult Cardiac Surgery and director of Interventional
Cardiology and the Heart Valve Program at the NYU Langone Medical
Center in New York City. "This innovation represents an important
advantage over previous generations of this device, as it can help
assist with adequate sealing even in complex cases."
The Evolut PRO Clinical Study (N=60) met its
primary endpoint at 30 days with high rates of survival (98.3
percent) and low rates of disabling stroke (1.7 percent). The
Evolut PRO valve also showed strong hemodynamic performance with
large aortic valve areas (2.0 ± 0.5 cm2) and mean
gradients in the single digits (6.4 ± 2.1 mm Hg) at 30 days. The
majority of study subjects (72.4 percent) experienced no/trace PVL
and no incidents of severe PVL were observed at 30 days.
Additionally, improving on the already low rates seen in Evolut R
clinical studies and real-world TVT and FORWARD registries, the
rate of new pacemaker implantation was 10 percent.
"The 30-day clinical outcomes presented at ACC
demonstrate the Evolut PRO valve to be an outstanding treatment
option for patients with severe aortic stenosis who are at a high
or extreme risk for surgery," said John Forrest, M.D., assistant
professor of medicine at Yale University School of Medicine in New
Haven, Conn., who presented the data at the meeting.
Built on the proven platform of the recapturable
CoreValve Evolut R System, the Evolut PRO valve includes a
self-expanding nitinol frame with its supra-annular valve position
that helps achieve excellent hemodynamic performance.
"Medtronic remains committed to working with
interventional cardiologists and cardiac surgeons to deliver
solutions that address patient needs with the safety and
performance profile they expect from Medtronic," said Rhonda Robb,
vice president and general manager of the Heart Valve Therapies
business, a part of Medtronic's Cardiac and Vascular Group. "We are
excited to introduce the next evolution of our Evolut TAVR platform
to provide physicians with a comprehensive portfolio to address
their patients' needs."
The Evolut PRO System is delivered through the
EnVeo(TM) R Delivery Catheter System and is indicated for vessels
down to 5.5 mm. The EnVeo R system features an InLine Sheath that
makes it the lowest delivery platform currently on the market. It
also provides a greater opportunity to treat patients with smaller
vessels through the preferred transfemoral access route.
The 23 mm, 26 mm and 29 mm sizes of the Evolut PRO
System are available for use in the United States. It is not
available for use in countries outside of the United States.
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 88,000 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
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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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