Clinical & Translational Research Institute


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8/14/2012 1:00:00 AM

First Patient Enrolled; Study Potentially To Benefit Thousands of Arizona Patients

PHOENIX (August 14, 2012) – Abrazo Health Care’s Clinical & Translational Research Institute announced today the enrollment of Arizona’s first patient in a cutting-edge clinical research trial that has potential to positively impact thousands of peripheral artery disease (PAD) patients.

Abrazo Health Care’s Arizona Heart Institute (AHI) and Arrowhead Hospital have been selected as trial sites for this five-year study. There are only three trial sites in Arizona.

The new study, called IN.PACT SFA II is a controlled (randomized) trial evaluating the advantages of the IN.PACT Admiral™ drug-eluting balloon (DEB) from Medtronic, Inc. (NYSE: MDT- News) over uncoated angioplasty balloons in patients with peripheral arterial disease. The DEB is inflated in the patient’s diseased artery and on inflation releases drug into the vessel wall. It is thought that the drug will reduce the body’s natural response to rapidly multiply plaque, and ultimately prevent or reduce the risk of recurrent plaque build-up. Two of every three patients who are enrolled into this trial will receive the investigational DEB, while the remaining one-third of subjects will receive treatment with a standard balloon; a treatment device is assigned by randomization.

Leading the trial for AHI, Dr. Venkatesh Ramaiah, vascular surgeon at Arizona Heart Institute and Arizona Heart Hospital, has successfully enrolled the first subject in Arizona into this trial. “As the baby boomer generation continues to age, the population of PAD patients in Arizona – and nationwide - is skyrocketing,” said Dr. Ramaiah. “There are currently multiple treatments for PAD, but they’re all associated with significant reoccurrence of the disease and need for additional treatments. This advancement is new, innovative, and has the potential to make a significant impact on PAD patients by eliminating the need for future procedures.”

More patients are currently under consideration for enrollment in the trial at both Arizona Heart Institute and Arrowhead Hospital. Dr. Rahul Malhotra, co-medical director of Arrowhead Hospital’s cardiac catheterization lab, is facilitating the IN.PACT SFA II trial in the west valley.

“PAD is estimated to affect 8 to 12 million people in the United States alone,” said Dr. Malhotra. “Unlike many research trials that benefit a small and targeted group of patients, the technology being tested in this trial has the potential to benefit an enormous patient population.”

The IN.PACT SFA II trial is one of the 55 clinical research trials Abrazo Health Care’s Clinical & Translational Research Institute is currently actively participating in. For more information about participating in the study, please visit

About Abrazo Health Care
As the second largest health care delivery system in Arizona, Abrazo Health Care is committed to providing excellent medical care to the residents of Maricopa County. The Abrazo system includes five acute care hospitals: Arrowhead Hospital, Maryvale Hospital, Paradise Valley Hospital, Phoenix Baptist Hospital and West Valley Hospital; and one specialized cardiovascular hospital, Arizona Heart Hospital; with a combined 1,027 licensed beds. In addition the system consists of two health plans: Phoenix Health Plan, and Abrazo Advantage, serving nine counties in the state; School-Based Health Centers; and Abrazo Medical Group with 70 employed physicians in 19 Valley locations. Visit for more information.

About Medtronic, Inc.
Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Teri Bockting/Page Englert
The Artigue Agency for Abrazo Health Care

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