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Medtronic Starts Enrollment in THRIVE, U.S. Post-Market Study of the Talent™ Thoracic Stent Graft
Lifesaving Medical Device Extends Benefits of Minimally Invasive Endovascular Repair of Aortic Aneurysms to More Patients
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Talent Thoracic
Stent Graft |
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April 27, 2009 -- Minneapolis -- Medtronic, Inc. (NYSE: MDT), today reported the start of THRIVE,
the company’s U.S. post-market clinical study of its Talent Thoracic
Stent Graft for the endovascular repair of thoracic aortic aneurysms.
The acronym THRIVE stands for Descending Thoracic Aortic Aneurysm
Endovascular Repair Post Approval Study |
An aortic aneurysm is a dangerous bulge
or weakness in the body’s main
artery. Untreated, aortic aneurysms can burst, commonly resulting
in death due to extensive internal bleeding. Thoracic aortic aneurysms
affect nearly 10 of every 100,000 elderly people in the United States.
Thoracic endovascular aortic repair (TEVAR)
is a minimally invasive procedure in which a stent graft – a fabric tube reinforced with metal
springs – is threaded through the femoral artery and expanded at the
site of the aneurysm. Once in place, the stent graft creates a new
path for blood flow, reducing pressure on the aneurysm and the risk
of rupture.
The alternative to TEVAR is open surgical repair.
Addressing a condition of U.S. Food and Drug
Administration (FDA) approval, THRIVE will enroll a total of 451 patients
at a minimum of 15 U.S.
sites. The study’s primary endpoint is freedom from aneurysm-related mortality (ARM) at five years, with ARM defined as death from aneurysm rupture or from any procedure intended to treat the segment targeted by the Talent Thoracic Stent Graft System. The study design incorporates the test group of 195 subjects from the earlier study that supported the device’s
FDA approval in 2008, as well as an additional 256 new subjects to
be prospectively enrolled. All subjects will be followed for five years.
“ THRIVE will gather clinically-relevant data on the long-term safety
and efficacy of the Talent Thoracic Stent Graft in a real-world, U.S.
patient population,” said Dr. Karthikeshwar Kasirajan, the principal investigator of THRIVE, and leader of the team that performed the first study implant on April 20 at Emory University Hospital in Atlanta. “In my experience, the Talent Thoracic Stent Graft System offers controlled deployment for placement accuracy, and enables more patients to be treated due to its broad range of diameters.” THRIVE
has been designed to evaluate how the benefits of the Talent stent
graft translate into clinical differences in routine practice.
With more than 10 years of clinical use worldwide, the Talent Thoracic Stent Graft has been implanted in more than 20,000 patients. The device was approved by the FDA in June 2008.
The unique features of the Talent Thoracic Stent Graft with the Xcelerant Delivery System include a broad range of diameters to treat a variety of anatomies; controlled deployment for easy and accurate stent graft placement; as well as high overall radial force for secure fixation.
A pioneer of endovascular aortic repair, Medtronic
has been an innovator and leader in the stent graft industry since
the 1990s. Its history
includes more than 150,000 patients treated with stent grafts. Medtronic
offers the broadest portfolio of aortic stent grafts. The AneuRx AAAdvantage® and Talent Abdominal Stent Grafts with the Xcelerant Hydro Delivery System and the Talent Thoracic Stent Graft with the Xcelerant Delivery System are commercially available in the United States. The Valiant® Thoracic Stent Graft and the Endurant® Stent Graft Systems are commercially available only outside the United States and are currently under clinical investigation in the United States. The Reliant® Stent
Graft Balloon Catheter is commercially available worldwide.
About Medtronic
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
Annual Report on Form 10-K for the year ended April 25, 2008. Actual
results may differ materially
from anticipated results.
Source: Medtronic,
Inc.
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