CLEVELAND, Jan. 24, 2012 /PRNewswire/ -- Physicians at University Hospitals (UH) Case Medical Center enrolled their first patient in LEVANT 2, a global, multicenter, randomized clinical trial evaluating the safety and efficacy of the Moxy™ Drug Coated Balloon for the treatment of peripheral arterial disease (PAD).
Co-investigators Sahil Parikh, MD, Michael Cunningham MD, and Vikram Kashyap, MD, with UH Harrington-McLaughlin Heart & Vascular Institute at UH Case Medical Center, were the first physicians to successfully implant the device in a patient.
LEVANT 2, sponsored by medical device manufacturer Lutonix, Inc., is the first drug-coated balloon pivotal trial to be approved by the FDA. UH Case Medical Center is one of 55 centers around the world participating in the trial, which is expected to randomize 476 patients with diseased femoropopliteal leg arteries.
The trial will investigate whether the Moxy balloon is more effective than standard angioplasty at keeping leg arteries open and free from re-blockage over time.
"The drug coated balloon is a novel approach for treating PAD -- traditional therapies required bypass surgery, but as minimally invasive techniques have evolved, we have been able to offer procedures such as angioplasty and stent placement in the legs," said Dr. Parikh, a cardiovascular medicine specialist with UH Case Medical Center, and Assistant Professor at Case Western Reserve University School of Medicine. "The problem has been that these treatments have been hampered by renarrowing due to the in-growth of scar tissue into the arteries known as restenosis."
According to Dr. Parikh, the latest drug coating technology for balloons was adapted from concepts applied to medicated stents during heart catheterizations.
"The advantage of a drug coated balloon is that it does not require the placement of a stent to be effective, and we believe, will prove to be