Allina's Mercy first in Minn. to enroll patient in world-wide drug-coated balloon trial

COON RAPIDS, MINN. 01/27/2012--Physicians at Mercy Hospital 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). Abdel Akef, MD, an interventional cardiologist at Mercy Hospital performed the case.

LEVANT 2, sponsored by medical device manufacturer Lutonix, Inc., is the first drug-coated balloon pivotal trial to be approved by the FDA. Mercy Hospital 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.

LEVANT 2 is the largest randomized peripheral drug-coated balloon clinical trial to date, and one of the largest peripheral vascular studies ever conducted. Randomized patients in LEVANT 2 will be followed for a total of 5 years, and independent core laboratories will be utilized to verify trial outcomes. The primary safety endpoint is a composite of freedom from all-cause peri-operative death and freedom at 1 year from amputation, re-intervention, and death. The primary efficacy endpoint is patency at one year.

"We believe this device could provide a substantially better treatment option for patients with PAD," said Daniel Dulas, MD, LEVANT 2 site investigator at Mercy Hospital. "As the only site in Minnesota, we are very proud of our ability to contribute to this important research and include ourselves in such a prestigious group of investigators around the world."

Drug-coated balloons are similar to standard angioplasty balloons except they are coated with an anti-restenotic drug aimed at preventing the artery from becoming blocked again. During the procedure, the Moxy balloon is inserted inside the narrowed area of the artery and then inflated in order to open the blockage and deliver the drug to the artery. After this short inflation, the balloon is removed from the body, leaving nothing but the drug behind in the artery.

"The potential opportunity to treat PAD without the use of a permanent implant is exciting. If the results of this trial are positive, we feel it could significantly change the way PAD is treated in the future," said Dulas. Dulas and his co-investigators at Metropolitan Heart and Vascular Institute are currently seeing patients for consideration in this trial.

LEVANT 2 is a follow-up trial to LEVANT 1, which was a 101-patient multicenter randomized trial. Patients either received the Moxy balloon or standard angioplasty for the treatment of diseased femoropopliteal arteries. Based on the positive results of the LEVANT 1 trial, LEVANT 2 was designed to investigate the device in a larger patient population.

"In trials of this magnitude and scientific rigor, it is imperative to have world-class research centers as your partners in the process. Mercy Hospital is such an institution, and we are deeply appreciative of the commitment and resources they have dedicated to successfully enrolling this trial," said Dr. Dennis Wahr, CEO and co-founder of Lutonix.

About Mercy Hospital

Mercy Hospital, part of Allina Hospitals & Clinics, is a non-profit hospital that serves the northwestern Minneapolis-St. Paul metropolitan area. Mercy responds to a wide range of health needs with specialty services including cancer care, heart and vascular services, mental health services, orthopedics, neurosciences, surgery and women's and children's services.

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