|
VALOR II Study Highlights
Strengths of Valiant® Thoracic Stent Graft from Medtronic
Innovative Medical Device Shows
Strong Safety and Efficacy in Treatment of Thoracic Aortic Aneurysms
Through One-Year of Patient Follow-Up in U.S. Clinical Study
|
 |
Valiant® Thoracic
Stent Graft from Medtronic |
|
June 18,
2011 -- Minneapolis and Chicago -- An innovative medical device
used in the minimally invasive treatment of thoracic aortic
aneurysms, the Valiant® Thoracic Stent Graft System from Medtronic,
Inc. (NYSE: MDT), delivered excellent clinical results through
one year of patient follow-up in the company’s U.S. pivotal
study, VALOR II, according to data presented today at a meeting
for vascular surgeons. A thoracic aortic
aneurysm (TAA) is a dangerous bulge in the body’s main artery
near where it branches off the heart; those that rupture usually
result in death. An estimated 60,000 people in the United States
alone have a TAA. Those that are detected before rupturing
can usually be effectively treated with stent grafts or invasive
surgery.
|
One-year results of the VALOR II study were
presented today during a late-breaking clinical trials session
at the annual meeting of
the Society for Vascular Surgery by principal investigator Dr.
Ronald Fairman, M.D., the Clyde F. Barker – William Maul Measey Professor
of Surgery at the Hospital of the University of Pennsylvania, where
he is chief of the division of vascular surgery and endovascular
therapy, and the department of surgery’s vice-chairman of clinical
affairs. Attended by more than 1,500 vascular surgeons, the three-day
2011 Vascular Annual Meeting in Chicago ends today.
“The VALOR II 12-month results demonstrate that the Medtronic Valiant stent graft is a safe and effective treatment for patients with descending TAA of degenerative etiology,” Dr. Fairman concluded. “Through
12 months, there were no cases of rupture or conversion to open surgery. Overall,
treatment results were quite promising.”
VALOR II is a prospective, single-arm study that involved 160 patients at 24 U.S. medical centers. It was designed to evaluate the safety and effectiveness of the Valiant Thoracic Stent Graft System for thoracic endovascular aortic repair (TEVAR) of aneurysms in the descending thoracic aorta.
The study met all of its prespecified endpoints.
The primary safety and effectiveness endpoints were 12-month all-cause
mortality and 12-month successful aneurysm treatment, defined as
the absence of (a) aneurysm growth (>5 mm) at one and 12 months,
and (b) type I and/or type III endoleak for which a secondary procedure
was performed or recommended at or before the 12-month visit.
Through one-year of follow up in VALOR II, the rate of all-cause mortality was 12.6 percent, with only 3.3 percent of mortalities deemed aneurysm-related. Nearly all patients (97.4%) achieved 12-month successful aneurysm treatment, and very few stent grafts (2.9%) migrated from their original placement
The Valiant Thoracic Stent Graft System is
indicated for the endovascular repair of fusiform aneurysms, saccular
aneurysms and penetrating ulcers of the descending thoracic aorta
in patients having appropriate anatomy, including: iliac or femoral
access vessel morphology that is compatible with vascular access
techniques, devices, and/or accessories, non-aneurysmal aortic diameter
in the range of 18–42 mm and non-aneurysmal aortic proximal and distal
neck lengths = 20 mm.
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.
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
periodic reports on file with the Securities and Exchange Commission.
Actual results may differ materially from anticipated results.
Source: Medtronic,
Inc.
|
