St. John Hospital enrolls first patient in Moxy- Drug Coated Balloon trial for PAD

Physicians at St. John Hospital and Medical Center have enrolled the first patient in Michigan in LEVANT2, a global, multicenter, randomized clinical trial evaluating the safety and effectiveness of the Moxy- Drug Coated Balloon for the treatment of peripheral arterial disease. Thomas Davis, M.D., SJH&MC interventional cardiologist 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. St. John Hospital is one of 55 centers around the world participating in the trial, which is expected to randomize 476 patients with diseased 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.

"We believe this trial may lead to a substantially better treatment option for patients with PAD," says Dr. Davis., LEVANT 2 site investigator at SJH&MC. "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-restenosis 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 Dr. Davis.

Restenosis refers to the re-narrowing of an artery following angioplasty or stenting. Restenosis is caused by an overgrowth of tissue inside the artery, typically in response to arterial injury at the original treatment site. Restenosis often occurs within the first 6 months following an intervention, and most often results in re-treatment.

LEVANT 2 is a follow-on 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 success and 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. St. John 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.