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St. John Hospital 1st in Michigan to enroll patient in worldwide drug-coated balloon trial
Date:8/29/2011

y 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.


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Contact: Brian Taylor
brian.taylor@stjohn.org
586-753-0726
St. John Providence Health System
Source:Eurekalert

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