First Patient Treated with Medtronic Valiant Evo Thoracic Stent Graft System
June 08 2016 - 9:00AM
Unique
Next-Generation Device Evaluated in International Clinical Trial;
First Procedure Performed at the University of Texas Health Science
Center at Houston
DUBLIN and HOUSTON - June 8, 2016
- Medtronic plc (NYSE: MDT) and the University of Texas Health
Science Center at Houston (UTHealth) today announced the first
patient enrolled in a clinical study assessing the Medtronic
Valiant(TM) Evo Thoracic Stent Graft System for the minimally
invasive repair of descending thoracic aortic aneurysms (TAA). The
international, multicenter, prospective study will include 100
patients in the U.S. and Europe. Today's news was reported at the
2016 Vascular Annual Meeting of the Society for Vascular Surgery in
National Harbor, Md.
Ali Azizzadeh, M.D., FACS, professor and chief of
division of Vascular and Endovascular Surgery in the department of
Cardiothoracic and Vascular Surgery at McGovern Medical School at
UTHealth, is the U.S. principal investigator for the trial and
performed the first procedure on a patient with a descending TAA.
Dr. Azizzadeh reports the first patient treated in the
investigational device exemption (IDE) trial is an 88-year-old male
who is doing well post-treatment.
"The Valiant Evo clinical study has the potential
to expand the applicability of thoracic endovascular aortic repair
(TEVAR) to a wider spectrum of patients," said Dr. Azizzadeh.
The Valiant Evo system is a lower profile
evolution of the market-leading Valiant Captivia(TM)system, which
has treated more than 85,000 patients globally. The Valiant Evo
system is designed to deliver a minimally invasive treatment option
to a greater number of patients with an 18F and 20F outer diameter
profile for most size configurations, proximal closed web and
FreeFlo configurations with tip capture, and high stent graft
conformability. Additional features include broader tapered
offerings and longer lengths for anatomical customization, in
addition to an improved ergonomic delivery system.
In the United States, the Valiant Evo is an
investigational device and not yet approved for commercial use.
"Medtronic is committed to developing meaningful
innovation to deliver better patient outcomes. With the Valiant Evo
system, we are leveraging a decade of clinical experience and
physician collaboration with the Valiant system, with a lower
profile device that may help to treat more complex aortic disease,"
said Daveen Chopra, vice president and general manager of the
Aortic business, which is part of the Aortic & Peripheral
Vascular division at Medtronic. "By listening to physicians we
believe that this innovation may support greater access to less
invasive treatment options for more patients globally."
Approximately six out of 100,000 people globally
experience a TAA, a blood-filled bulge or ballooning of the aorta
that runs through the chest and can lead to a life-threatening
rupture and hemorrhage if not treated. Most people with TAA do not
have any symptoms; however, risk factors include smoking, obesity,
heredity, injury, or other disease.
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.
The Medtronic Valiant(TM) Evo Thoracic Stent Graft
System
Click the thumbnail above for a larger image.
About UTHealth
Established in 1972 by The University of Texas System Board of
Regents, The University of Texas Health Science Center at Houston
(UTHealth) is Houston's Health University and Texas' resource for
health care education, innovation, scientific discovery and
excellence in patient care. The most comprehensive academic health
center in The UT System and the U.S. Gulf Coast region,
UTHealth is home to schools of biomedical
informatics, biomedical
sciences, dentistry, nursing and public
health and the John P. and Kathrine G. McGovern Medical
School. UTHealth includes The University of Texas Harris
County Psychiatric Center and a growing network of
clinics throughout the region. The university's primary
teaching hospitals include Memorial Hermann-Texas Medical
Center, Children's Memorial Hermann
Hospital and Harris Health Lyndon B. Johnson Hospital.
For more information, visit www.uth.edu.
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 85,000 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:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
HUG#2018383
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2023 to Apr 2024