Talent Stent Graft Shows
Durable Performance in Patients with Abdominal Aortic Aneurysms
Five-Year Results from U.S. Clinical
Trial Presented at 2009 Vascular Annual Meeting
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Talent Thoracic
Stent Graft |
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June 15,
2009 -- Minneapolis -- Through five years
following initial implantation in an FDA-approved study, the
Talent Abdominal Stent Graft from Medtronic, Inc. (NYSE: MDT),
demonstrated durable safety and effectiveness in patients with
abdominal aortic aneurysms, despite having included patients
with more challenging anatomies than comparable trials of similar
medical devices. |
The five-year results from the Talent AAA
U.S. IDE (investigational device exemption) study were presented
on Friday,
June 12th at the clinical trial session of the Society for Vascular
Surgery (SVS). The study results support the long-term safety and
efficacy of the Talent Abdominal Stent Graft in the minimally-invasive
treatment of abdominal aortic aneurysms. Earlier data from the study
contributed to the original FDA approval for the device in April
2008. These latest data constitute the final results of the study,
which involved 166 patients enrolled between February 2002 and April
2003 at 13 clinical research sites in the United States.
“In a population with more challenging anatomical characteristics
than in other clinical trials of similar technologies for endovascular
repair of abdominal aortic aneurysms, the Talent Stent Graft System
compared favorably with open repair through one year,” said
Dr. Luis Sanchez of Washington University Hospital in St. Louis,
who shared the findings with hundreds of physicians attending the
2009 Vascular Annual Meeting. “More importantly, the Medtronic
device also provided sustained protection from aneurysm-related mortality
through five years, with minimal reinterventions.”
The study’s primary safety endpoint
compared a composite of major adverse events (MAE) to an historical
control of 243 patients
who underwent conventional open surgical repair of their aneurysm.
Freedom from MAE at 30 days was 89.2 percent in the Talent AAA group
and 44 percent in the open surgical repair group.
The effectiveness endpoint assessed successful aneurysm treatment,
defined as technical success with device placement, as well as freedom
from aneurysm growth greater than 5 mm and freedom from Type I or
III endoleak, at one year. Successful aneurysm treatment at 12 months
was obtained in 90.2 percent of the Talent AAA study population.
Other highlights of the five-year outcomes include a 96.5 percent
freedom from aneurysm-related death, freedom from AAA rupture of
98.2 percent , freedom from conversion to open repair of 99.1 percent,
and freedom from migration of 97.7 percent.
“At five years, not only were outcomes related to aneurysm-related
mortality, conversion to surgery and rupture satisfactory, but the
incidence of device migration was only 2.3 percent,” said principal
investigator Dr. Frank Criado at Union Memorial Hospital in Baltimore.
Importantly for interpreting the results, this study enrolled a
significant number of patients with challenging AAA morphology who
would have been excluded from IDE trials of other stent graft products
because of stricter inclusion criteria in those trials and limited
device size offerings.
The Talent Abdominal Stent Graft expands
the applicability of endovascular aortic repair (EVAR), enabling
more patients to benefit from a less
invasive alternative to open surgical repair. Talent AAA is the only
stent graft approved by the FDA for use in the treatment of abdominal
aortic aneurysms with proximal necks (“landing zones”)
as short as 10 mm. The Talent Abdominal Stent Graft System has been
used internationally since 1997 to repair the aortic aneurysms of
approximately 50,000 patients.
A pioneer of EVAR, Medtronic has been an
innovator and leader in the stent graft industry since the 1990s,
with more than 150,000
patients treated with its devices. The company offers the broadest
portfolio of stent grafts. Among these are the Talent Abdominal and
Thoracic Stent Grafts in the United States, as well as the Endurant® Abdominal
and the Valiant® Thoracic Stent Grafts outside the United States.
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 Medtronics
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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