2013-04-29 16:03:02 -
FDA's Early Feasibility Pilot Program for New Medical Devices
Encourages Clinical Studies of Innovative Technology to Occur First in U.S.
MINNEAPOLIS -- April 29, 2013 -- Vascular specialists at Carolinas HealthCare
System in Charlotte, N.C., and the Cleveland Clinic in Ohio recently performed
the initial implants of a novel stent graft system from Medtronic, Inc. (NYSE:
MDT) as part of a U.S. Food and Drug Administration (FDA) initiative designed to
encourage more early-stage clinical research on new medical devices in the
United States. These implants were among the first to be performed under this
FDA early feasibility pilot program, which includes a total of nine medical
devices from different companies.
The first device of its kind to undergo clinical evaluation anywhere in the
world, Medtronic's Valiant Mona LSA branch
stent graft system is designed to
enable the repair of thoracic aortic aneurysms encroaching on the left
subclavian artery (LSA) with an entirely endovascular approach. Its initial
usage earlier this month marks a major step forward in the company's efforts to
develop standardized stent graft systems to treat aneurysms throughout the aorta
when the involvement of a branch vessel requires the stent graft to allow
perfusion of critical organs or tissue.
Investigators Envision Future
"A standardized stent graft system that addresses the anatomical variability in
thoracic aortic aneurysms involving the LSA could make this repair technique
even less invasive for a large number of patients," said the study's primary
investigator, Dr. Eric Roselli, a cardiothoracic surgeon at the Cleveland
Clinic. "This trial is a first step toward developing more disease-specific and
patient-specific devices to treat a very complex disease problem."
Dr. Frank Arko, a vascular surgeon at Carolinas HealthCare System's Sanger Heart
& Vascular Institute and the site's lead investigator, added: "This endovascular
treatment for aortic aneurysms provides an important alternative to open-chest
operations. By eliminating the need for invasive surgeries, we should be able to
reduce certain complications and hopefully improve outcomes for patients facing
a life-threatening illness."
Approved by the FDA under an investigational device exemption, the clinical
study of Medtronic's Valiant Mona LSA branch stent graft system may enroll a
total of seven patients at Carolinas HealthCare System and the Cleveland Clinic
"This study will advance the development of future devices for the endovascular
repair of aortic aneurysms that involve branch vessels," said Tony Semedo,
president and general manager of Medtronic's Endovascular Therapies business.
"It represents a gateway to stent grafts that could be used to treat aneurysmal
disease across the aorta's thoracic arch and ascending segment."
The investigational device is based on the market-leading Valiant thoracic stent
graft, which has been used to treat approximately 45,000 patients worldwide
since 2005 when it received the CE (Conformité Européene) mark. It features
modifications to the standard device, including a branch cuff that accommodates
the LSA branch graft.
The LSA carries oxygenated blood to the posterior brain and left arm. Published
reports show a higher rate of stroke and mortality associated with coverage of
the LSA during endovascular repair of thoracic aortic aneurysms. As a result,
the Society for Vascular Surgery suggests routine revascularization of the LSA
in elective cases where achievement of an adequate seal zone for the stent graft
requires coverage of the LSA.
Approximately 60,000 people in the United States are living with a thoracic
aortic aneurysm, a dangerous bulge in the body's main artery near where it
originates from the heart that can rupture with catastrophic consequences if
left untreated -- although only about half are ever diagnosed, due to lack of
symptoms. In an estimated 40 percent of these patients, the aneurysm encroaches
on the LSA, making an entirely endovascular repair more challenging.
A stent graft is a tubular medical device consisting of a metal frame, or stent,
sewn onto a polyester fabric, or graft. It is delivered through a pre-loaded
catheter inserted in the patient's femoral artery. Once deployed, the stent
graft conforms to the wall of the aorta, creating a new path for blood flow that
reduces pressure on the aneurysm and the risk of rupture.
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
Drs. Arko and Roselli are both paid consultants and speakers for Medtronic. Dr.
Roselli serves on an unrelated Medtronic advisory board.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology -- alleviating pain, restoring health and extending
life for millions of people around the world.
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
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Source: Medtronic, Inc. via Thomson Reuters ONE