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First Patient Enrolled in Lutonix Drug-Coated Balloon Pivotal Trial
Date:7/25/2011

MINNEAPOLIS, July 25, 2011 /PRNewswire/ -- Lutonix today announced the first patient enrolled in the LEVANT 2 clinical trial, a global, multicenter, randomized trial evaluating the safety and efficacy of the Moxy™ Drug Coated Balloon compared to a standard angioplasty balloon for the treatment of peripheral arterial disease (PAD).  The first case was performed at St. John's Hospital in Springfield, IL by Dr. Jeff Goldstein.

LEVANT 2 is the first drug-coated balloon IDE trial to be approved by the FDA, and is being conducted to support a PMA application for US approval of the company's Moxy balloon.  The trial is expected to randomize approximately 476 patients at up to 55 hospitals worldwide.  LEVANT 2 is the largest randomized peripheral drug-coated balloon 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 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 primary patency at 1 year.  Dr. Kenneth Rosenfield (Massachusetts General Hospital, Boston MA) and Prof. Dierk Scheinert (Heart Center Leipzig/Park Hospital, Leipzig Germany) are the co-principal investigators of the trial.  

"We are very pleased to be the first center to contribute to such an important trial.  We believe drug-coated balloons may play an important role in the future of peripheral interventions, and we are proud to be involved in such a well-designed, carefully controlled trial to explore this promising new therapy," said Dr. Goldstein, site principal investigator at St. John's Hospital.

Co-investigator Dr. Krishna Rocha-Singh added, "With 8-12 million patients known to suffer from PAD and a paucity of durable, highly e
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SOURCE Lutonix, Inc.
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