Medtronic Unveils Strong Early Outcomes for the Intrepid(TM) Transcatheter Mitral Valve Replacement (TMVR) System
(Thomson Reuters ONE) -
First Report Investigation at TCT Published in JACC Shows Substantial Mitral
Valve Regurgitation Reductions and Versatility of Dual-Stent Design
DUBLIN and DENVER - November 1, 2017 - Medtronic plc (NYSE:MDT) today presented
positive data for its self-expanding Intrepid((TM)) transcatheter mitral valve
replacement (TMVR) system in patients with severe, symptomatic mitral valve
regurgitation. Presented as a First Report Investigation at the Transcatheter
Cardiovascular Therapeutics (TCT) Annual Meeting and simultaneously published in
the Journal of the American College of Cardiology (JACC), data from the first
50 consecutive patients enrolled in the Intrepid Pilot Study demonstrated
successful device implantation and a substantial reduction in mitral
regurgitation at 30-days. The new data come on the heels of the first patient
implant in the APOLLO trial, the first-ever pivotal trial approved by the U.S.
Food and Drug Administration (FDA) to evaluate the safety and efficacy of the
Intrepid TMVR system.
"These early outcomes with the Intrepid TMVR System are encouraging as we
investigate a minimally-invasive alternative to surgical mitral valve
replacement," said Paul Sorajja, M.D., Headrick Family Chair, Valve Science
Center at the Minneapolis Heart Institute Foundation and presenter of the
Intrepid Pilot Study data at TCT. "The Intrepid TMVR System is easy to implant
in the challenging mitral anatomy due to its conformable, dual stent design and
the device corrects the underlying mitral regurgitation in a significant
majority of patients."
The Intrepid Pilot Study was designed to evaluate valve safety and performance
of the IntrepidTMVR System across sites in the United States, Europe, and
Australia. Initial 30-day outcomes showed that the Intrepid TMVR System was
successfully implanted in 98 percent of patients. The early results also
demonstrated notable reductions in mitral regurgitation with patients
experiencing either none/trace or mild mitral regurgitation at 30-days compared
to moderate to severe at baseline. Patients also continued to have symptomatic
improvements with 79 percent of patients classified as NYHA (New York Heart
Association) class I or class II at their last follow-up.
"It is an exciting time for mitral valve replacement therapy as demonstrated by
the promise of such truly innovative technologies that can positively impact
patients suffering from mitral valve disease," said Vinayak Bapat, M.D.,
cardiothoracic surgeon at Columbia University Medical Center/New York-
Presbyterian Hospital, and principal investigator of the Intrepid Pilot Study.
"We look forward to further investigation of the Intrepid TMVR System with the
landmark APOLLO pivotal trial, which just got underway."
The Intrepid TMVR system integrates self-expanding, dual-stent technology with a
tissue valve to facilitate catheter-based implantation without the need for
open-heart surgery. The Intrepid valve is compressed inside a hollow delivery
catheter and is inserted between the ribs to enter the heart. The new
replacement valve is expanded directly into the malfunctioning mitral valve. The
outer stent frame is designed to attach and conform to the malfunctioning native
valve without the need for additional sutures or tethers to secure the device in
place. The inner stent houses the valve, which is made from bovine tissue and is
intended to maintain blood flow.
The Intrepid TMVR system is available for investigational use only and it is not
approved for use outside of clinical studies.
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
+1-763-381-1204
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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