Medtronic Announces Clinical Study of Transcatheter Aortic Valve Replacement in Aortic Stenosis Patients with Bicuspid Valves
September 18 2018 - 10:02AM
Medtronic Receives
FDA Approval for Revised TAVR Labeling and Begins Investigational
Study of Low Risk Patients with Bicuspid Valves
DUBLIN - September 18, 2018 -
Medtronic plc (NYSE:MDT) today announced that the U.S. Food and
Drug Administration (FDA) has approved an investigational device
exemption (IDE) to initiate a single-arm study to evaluate the
CoreValve Evolut(TM)TAVR system in patients with bicuspid aortic
valves who are at low risk of surgical mortality. Medtronic
separately received FDA approval for revised commercial labeling
for the CoreValve Evolut TAVR system that removed a precaution for
the treatment of bicuspid severe aortic stenosis patients deemed at
intermediate or greater risk for surgical aortic valve
replacement.
"Real-world data suggests that TAVR with the
self-expanding Evolut can be a suitable treatment option for many
patients with bicuspid aortic valve disease," said Jeffrey J.
Popma, M.D., director of Interventional Cardiology at the Beth
Israel Deaconess Medical Center in Boston, Mass. "In fact, data
from the TVT Registry has shown near-parity in certain outcomes
between bicuspid and tricuspid patients using the Evolut
self-expanding platform."
Estimated to affect 1 in 5 patients undergoing
surgical aortic valve replacement (SAVR), bicuspid valve patients
are born with two aortic valve leaflets instead of the more common
three leaflets (tricuspid). While the revised labeling approval
pertains to patients deemed at Intermediate Risk or greater for
SAVR, Medtronic is studying bicuspid patients within a separate
single-arm study of the Low Risk TAVR Trial. In the U.S., use for
treatment with bicuspid aortic valves in patients who are at low
risk of surgical mortality is investigational use only.
"As a leader in heart valve solutions, this label
revision enables us to provide proactive training and education on
procedural TAVR sizing and placement in this patient population,"
said Pieter Kappetein, M.D., vice president, medical affairs for
Structural Heart business, which is part of the Cardiac and
Vascular Group at Medtronic. "The bicuspid study, in addition to
new studies on TAVR efficiencies and leaflet mobility, will provide
important insights as we look to further refine TAVR therapy."
Medtronic is a leading innovator of heart valve
therapies, including the first transcatheter pulmonic valve, the
first self-expanding and recapturable transcatheter aortic valve,
and the first transcatheter mitral valve replacement technology to
be studied in a global pivotal trial. Following the launch of the
self-expanding CoreValve System in 2014, and the Evolut(TM) R
system in 2015, the third-generation Evolut(TM) PRO TAVR system was
approved in the U.S. and Europe for extreme-, high-, and
intermediate-risk patients in 2017.
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 86,000 people worldwide, serving physicians,
hospitals and patients in more than 150 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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