News Release- December 4th
Mercy Enrolls First Patient in Drug-Coated Balloon Study
Chicago IL: Mercy Hospital and Medical Center was selected in June of this year to participate in Medtronic’s IN.PACT SFA II Study, the company’s first U.S. clinical trial for its line of drug-eluting balloons as an alternative treatment for peripheral artery disease in the lower extremities. Mercy is one of only thirty-four (34) sites across the U.S. that was selected to participate in this landmark study and enrolled its first patient on August 1st.
Paul Jones, M.D., Chair of Cardiovascular Services is the principal investigator of the Medtronic IN.PACT SFA II study. After giving an oral presentation at prestigious LINC Endovascular Conference in Leipzig, Germany, Dr. Jones was approached by Medtronic leadership and asked to participate in this esteemed trial as the only hospital in Chicago.
“We are constantly looking for new, innovative and effective therapies for the treatment of peripheral artery disease, which is estimated to affect eight to 12 million people in the United States and results in more than 94,500 amputations per year. We at Mercy Hospital are privileged to be part of this trial and eager to bring these newer technologies to our patients” said Paul Jones, M.D.
The Medtronic IN.PACT 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 device for treating de novo and non-stented restenotic atherosclerotic lesions in these vessel beds.
Patients are randomized 2:1 treatment with either Medtronic’s IN.PACT Admiral drug-eluting balloon or a standard angioplasty balloon. Patients are then monitored and given quality of life tests for duration of 5 years, 60 months to measure the impact.
According to Dr. Favrizio Fanelli, renowned Vascular and Interventional Radiologist at Sapienza, Universita DI Roma, this therapy has been successfully used in Europe,” says Dr. Jones. Dr. Jones was recently visited by, Dr. Favrizio Fanelli who shared his vast experience using drug eluting balloons in Europe noting that the over the past several years these balloons has decreased their use of stents by 80% in the treatment of SFA disease with exceptional outcomes.
“What’s attractive about the procedure is that nothing is left behind in the vessel; the drug’s rapid release and prolonged retention, allows the vessel to remain open with hopes that there are no further blockages for the patient,” said Jones.
To learn more about Mercy’s Heart & Vascular Center visit www.mercy-chicago.org/heart
About Mercy’s Heart & Vascular Center
Mercy Hospital & Medical Center is also home to one of the city's leading Heart & Vascular Centers, a Stroke Center, a Center for Weight Management, and Chicago’s newest advanced Emergency Center. Mercy's ideal location, just minutes south of the loop, is easily accessible by all main arteries. And at Mercy, patients and visitors will find convenient, free parking.