MINNEAPOLIS –– Expanding its commitment to developing
innovative treatments for cardiovascular disease and the evidence to support
their adoption, Medtronic, Inc. announced today the start of the
Medtronic IN.PACT SFA II study, the company’s first U.S. clinical trial for its
line of IN.PACT drug-eluting balloons.
The first patients in this landmark study were treated this
week by Dr. Ash Jain at Washington Hospital in Fremont, Calif., and Dr. Brian Bigelow at St.
Vincent Hospital in Indianapolis; Dr. Monica Hunter at Christ
Hospital in Cincinnati is planning to treat a patient in
the study as early as next week. Drs. Jain, Bigelow and Hunter are the
principal investigators at their respective trial site.
Peripheral artery disease is estimated to affect eight to 12
million people in the United
States alone. A prevalent form of
cardiovascular disease, lower-extremity peripheral artery disease is a prime
cause of claudication (ischemic leg pain) and immobility, critical limb
ischemia and amputations.
The Medtronic IN.PACT SFA II study will evaluate the safety
and effectiveness of the company’s IN.PACT Admiral drug-eluting balloon in the
treatment of peripheral artery disease in the superficial femoral artery and/or
proximal popliteal artery. Specifically, the trial will examine the effect of
this novel device for treating de novo and non-stented restenotic atherosclerotic
lesions in these vessel beds.
The Medtronic IN.PACT SFA II study is a prospective,
multicenter randomized controlled trial that will involve several hundred
patients at up to 55 U.S.
sites. Patients will be randomized 2:1 to treatment with either Medtronic’s
IN.PACT Admiral drug-eluting balloon (study arm) or a traditional non-coated
angioplasty balloon (control arm).
The principal investigators of the Medtronic IN.PACT SFA II
study are interventional cardiologist Dr. John Laird, professor of medicine at
the University of California Davis and medical director of the UC Davis
Vascular Center, and vascular surgeon Dr. Peter Schneider, chief of the
vascular therapy division at Kaiser Foundation Hospital
and Hawaii Permanente Medical Group in Honolulu.
“Drug-eluting balloons represent an exciting and innovative
therapy in the advancement of peripheral artery disease treatment,” said Dr.
Laird. “The concept of delivering an anti-restenotic agent to the vessel while
leaving nothing behind is very attractive.”
“Medtronic is a leader in the development of this novel
drug-delivery device, and I am excited to partner with the company on IN.PACT
SFA II. Dr. Schneider and I would also like to congratulate our colleagues at Washington Hospital,
St. Vincent Hospital
and Christ Hospital for being the first activated
sites in this landmark study.”
Once complete, data from the Medtronic IN.PACT SFA II study
will be combined with those from the Medtronic IN.PACT SFA I study –– currently
underway in Europe and led by principal investigator Dr. Gunnar Tepe, chief of
radiology at Klinikum Rosenheim in Germany –– and is intended to
support a premarket approval (PMA) application to the U.S. Food and Drug
Administration (FDA). The combined enrollment in the two Medtronic studies ––
IN.PACT SFA I and II –– is expected to total approximately 450 patients.
Ultimately, Medtronic’s global IN.PACT clinical program will
include 24 studies involving approximately 4,000 patients and 200 sites across
more than 80 countries worldwide. Through these company-sponsored and
physician-initiated studies, Medtronic IN.PACT drug-eluting balloons will be
investigated thoroughly for the treatment of arterial disease in coronary and
peripheral vessel beds. To date, seven of these studies have completed
enrollment and 10 others have begun enrollment.
“As treatment of peripheral artery disease has moved to
endovascular as a primary option, we are constantly seeking out more effective
technologies for our patients,” said Dr. Schneider. “As data accumulates around
the world, drug-eluting balloons may someday play a major role in treating
narrowed arteries in the lower extremities. Dr. Laird and I are privileged to
help assess this exciting new option for U.S. patients.”
Medtronic’s IN.PACT drug-eluting balloons feature a
proprietary coating called FreePac that is a formulation of paclitaxel and
urea, an excipient that facilitates absorption of the drug into the vessel
wall. They received the CE (Conformité Européenne) mark in 2008 and 2009 and
are available in many countries around the world. They are not commercially
available in the United
States; the Medtronic IN.PACT Admiral
drug-eluting balloon is limited to investigational use under an investigational
device exemption (IDE) granted by the FDA.
More information about the Medtronic IN.PACT SFA II clinical
study is available online at www.inpactsfa2.com.
In collaboration with leading clinicians, researchers and
scientists, 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
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.