Medtronic Begins Real-World Post-Market Study of the Valiant Navion Thoracic Stent Graft System in Patients with Thoracic Aor...
July 06 2020 - 10:00AM
Medtronic plc (NYSE:MDT), the global leader in medical
technology, today announced the start of a prospective,
observational, global, multi-center, real-world, post-market study
to evaluate the safety and effectiveness of the Valiant Navion™
Thoracic Stent Graft System in the treatment of thoracic aortic
dissection. The first patient procedure in the DISSECT-N study
was performed at Northwell Health in New York, New York by Derek
Brinster, M.D., director of Aortic Surgery.
“Treatment of aortic dissection is often
challenging, especially as patients with fragile aortas have
different needs. The Valiant Navion CoveredSeal configuration,
designed with fragile aortic tissue in mind, can be especially
helpful in treating this condition,” said Ross Milner,
M.D., director of the Center for Aortic Diseases at the
University of Chicago Medicine in Chicago and U.S. principal
investigator for the DISSECT-N study. “I believe the DISSECT-N
study — one of the larger prospective aortic dissection repair
studies, which includes independent core-lab imaging review — will
offer critical contemporary insights about TEVAR use in patients
with various types of thoracic aortic dissection.”
The DISSECT-N study will enroll at least 200
patients with an acute or chronic thoracic aortic dissection across
approximately 45 sites in North America, Europe, and Asia
Pacific. The primary endpoint is composite safety and
effectiveness, including technical procedure success and
freedom from major adverse events (MAEs) reported up to one month
following the index procedure. Patients will be followed for
three years. Primary investigators are Dr. Milner and Robin
Heijmen, M.D., Ph.D., cardiothoracic surgeon at St.
Antonius Hospital in the Netherlands.
“Thoracic aortic dissection is dangerous, with
some cases leading to severe internal bleeding or irreversible
organ damage; with the Valiant Navion system, more patients with
aortic dissection are eligible for thoracic endovascular
aneurysm repair (TEVAR),” said Dr. Heijmen, European principal
investigator for the DISSECT-N study. “I am pleased to support
the generation of real-world evidence in this landmark study, which
I believe will help enable the clinical community to optimally
treat patients with thoracic aortic dissection using this
technology.”
“There remains a significant clinical unmet need
in treating thoracic dissection, and we are dedicated to improving
the care for these patients through an endovascular approach,”
said John Farquhar, vice president and general manager of the
Aortic business, which is part of the Cardiac and Vascular Group at
Medtronic. “With the DISSECT-N study, we hope to further
support the Valiant Navion system as a less invasive approach to
treating this condition.”
The low-profile Valiant Navion system
received U.S. Food and Drug Administration approval in
October 2018, CE Mark in November 2018,
and approval from the Ministry of Health, Labour and
Welfare (MHLW) in Japan in September 2019.
An aortic dissection is a serious condition in
which the inner layer of the lower aorta is torn, causing the inner
and middle layers of the aorta to separate (dissect). If the
blood-filled channel ruptures through the outside aortic wall,
aortic dissection is often fatal.1 About two-thirds of people
who have an aortic dissection are male, and those with high blood
pressure or high cholesterol may be at greater risk.2
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 of the highest quality that deliver clinical and economic
value to healthcare consumers and providers around the world.
About MedtronicMedtronic 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 90,000 people worldwide, serving physicians,
hospitals and patients in approximately 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-
1 “Aortic Dissection.” Mayo
Clinic, https://www.mayoclinic.org/diseases-conditions/aortic-dissection/symptoms-causes/syc-20369496.
Accessed 10 March 2020.
2 “Your Aorta: The Pulse of
Life.” American Heart
Association, https://www.heart.org/en/health-topics/aortic-aneurysm/your-aorta-the-pulse-of-life.
Accessed 10 March 2020.
Julia FullerPublic Relations+1-707-210-2069
Ryan WeispfenningInvestor Relations+1-763-505-4626
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