First Patient Treated in Landmark Transcatheter Mitral Valve Replacement (TMVR) Pivotal Trial
(Thomson Reuters ONE) -
Global Medtronic APOLLO Trial Now Underway with the Intrepid(TM) TMVR System for
Patients with Severe Mitral Regurgitation
DUBLIN - October 23, 2017 - Medtronic plc (NYSE:MDT) today announced the first
patient implant in the APOLLO Trial - the pivotal trial designed to evaluate the
Intrepid(TM) TMVR system following receipt of an investigational device
exemption (IDE) from the U.S. Food and Drug Administration (FDA). As the first-
ever pivotal trial for transcatheter mitral valve replacement therapy, the study
will evaluate the safety and efficacy of the Intrepid TMVR system in up to
1,200 patients with severe, symptomatic mitral valve regurgitation.
The first patient in the APOLLO trial was implanted by the team at Aurora St.
Luke's Medical Center in Milwaukee.
"This is the beginning of an important journey to establish a truly less
invasive approach to treat severe mitral valve regurgitation in patients who are
appropriate candidates for mitral valve replacement with a transcatheter
technology that eliminates the need for open-heart surgery," said David H.
Adams, M.D., surgeon-in-chief of Mount Sinai Health System, and national co-
principal investigator of the APOLLO Trial.
The APOLLO Trial Design
The APOLLO Trial design consists of two cohorts and will be conducted at up to
60 sites to evaluate two distinct patient populations. The primary endpoint in
both cohorts of the trial is a composite endpoint rate of all-cause mortality,
all-stroke, reoperation (or reintervention) and cardiovascular hospitalization
at one year with secondary endpoints that measure quality of life and valve
performance in patients with severe symptomatic mitral regurgitation.
The randomized cohort will enroll up to 650 patients who are candidates for
conventional open-heart mitral valve replacement surgery and not eligible for
mitral repair. These patients will be evenly randomized to receive either the
Intrepid TMVR system or conventional mitral valve surgery. The primary endpoint
is designed to demonstrate the Intrepid TMVR system is statistically non-
inferior to conventional surgery at one year.
The single arm cohort will enroll up to 550 patients who are considered too high
a risk for conventional open-heart mitral valve surgery as determined by a
multi-disciplinary heart team and will be assigned to undergo the TMVR procedure
with the Intrepid system. The primary endpoint of this cohort is designed to
demonstrate statistical non-inferiority to a performance goal at one year.
"We worked closely with the FDA and leading physicians to design a trial that
will compare the Intrepid TMVR system with the current standard of care for
patients with mitral regurgitation," said Sean Salmon, senior vice president and
president of the Coronary and Structural Heart division, which is part of the
Cardiac and Vascular Group at Medtronic. "We are excited to investigate whether
this technology holds promise for the large number patients suffering from the
debilitating symptoms of severe mitral regurgitation."
Mitral Regurgitation and the Intrepid TMVR System
Mitral regurgitation occurs when blood flows backward through the mitral valve
and into the atrium each time the left ventricle contracts. If left untreated,
mitral regurgitation can lead to heart failure or death. Due to the complexity
of the mitral valve anatomic structure and multiple comorbidities typically
present in such patients, limited medical therapies are available to clinicians
and their patients.
The Intrepid TMVR system integrates self-expanding, dual-stent technology with a
replacement tissue heart valve to facilitate a catheter-based implantation. 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 native valve without the need for additional
sutures, tethers, or anchors to secure the prosthesis. The inner stent houses
the valve, which is made from bovine tissue and is intended to maintain blood
flow.
"The Intrepid system features a truly innovative dual-stent design and the trial
will investigate its safety and efficacy in addressing severe symptomatic mitral
regurgitation replacing the need for an open-heart procedure," said Martin Leon,
M.D., director of the Center for Interventional Vascular Therapy at Columbia
University Medical Center/New York-Presbyterian Hospital, and national co-
principal investigator of the APOLLO Trial. "We look forward to working with the
APOLLO Trial clinical sites in the U.S. and around the world."
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
Unternehmensinformation / Kurzprofil:
Datum: 23.10.2017 - 15:00 Uhr
Sprache: Deutsch
News-ID 564761
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