Medtronic’s CoreValve
Shows Subclavian Access Success in Patients Contraindicated for
Femoral Approach
Excellent Procedural Success
with Subclavian Approach Using Medtronic’s
CoreValve in Patients with Compromised Peripheral Vasculature
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May 20, 2009 -- Barcelona --
Medtronic, Inc. (NYSE: MDT) announced new data presented today on the
safety and effectiveness of Medtronic’s CoreValve system via
a novel, subclavian approach. The data reported procedural success
of 100 percent; 24-hour survival of 100 percent; and 30-day survival
of 89 percent. The available 30-day analysis also demonstrated clinical
improvement in heart failure symptoms with 76 percent of the patients
gaining at least a one-stage NYHA class and one-third improving by
at least two stages.
Medtronic’s market-leading CoreValve
system was designed to allow the implant of a replacement heart
valve in patients with aortic
stenosis who are at high or prohibitive surgical risk. The system
enables a catheter-based implant via a peripheral blood vessel, traditionally
the femoral artery. A significant subset of patients, however, have
compromised peripheral arteries, which prevents the use of the femoral
approach. Uniquely, the delivery system of the CoreValve device is
small enough to allow an alternative approach via the subclavian
artery beneath the collar bone.
“The combination of unique valve design and controlled deliverability
have contributed to the tremendous success of the Medtronic CoreValve
system using the femoral approach,” said John Liddicoat M.D.,
vice president and general manager of the CardioVascular Structural
Heart division at Medtronic. “These new data suggest that a
subclavian artery approach could address yet another under-served
patient population. We are committed to gather the necessary clinical
experience and evidence to support the routine use of a subclavian
approach in those for whom a femoral approach is not possible.”
The data presented today at the PCR interventional cardiology meeting
in Barcelona reported on data from 74 patients for whom subclavian
access was used within the CoreValve Extended Evaluation Registry,
an observational study which closed in January 2009. The average
age of the patients was 81.4. Moreover, the average Logistic EuroSCORE
(a measure which predicts risk of procedural mortality based upon
patient status) was notably high at 28.4%.
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.
Note: The Medtronic CoreValve System is not currently available
in the United States for clinical trials or for sale.
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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