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

ffective therapies, patients and physicians are in need of a game-changing treatment modality.  The LEVANT 2 trial will help us determine whether a drug-coated balloon can fill this gap."  

Drug-coated balloons have received growing attention in recent years as physicians increasingly look for effective ways to treat diseased leg arteries without having to leave a permanent stent implant behind.  Like the drug-eluting stents commonly used in the heart, the Moxy balloon delivers a powerful restenosis-fighting drug to the artery.  However, unlike a stent, the Moxy balloon is removed from the body after use, leaving nothing but the drug behind in the artery.  

Physician enthusiasm for the drug-coated balloon concept has been bolstered by encouraging results from early trials like LEVANT 1, a precedent study to LEVANT 2.  LEVANT 1 was a 101-patient randomized trial in which the Moxy balloon was compared to standard angioplasty for the treatment of diseased femoropopliteal arteries.  The trial showed the Moxy balloon had the ability to safely and substantially inhibit restenosis.

"There is tremendous enthusiasm within the medical community about the potential for drug-coated balloons to improve outcomes for our patients," explained Dr. Rosenfield.   "However, because the field is young, we need data from large, randomized controlled clinical trials that are independently validated.  Because of its scientific rigor, LEVANT 2 will help address this need.  On behalf of Dr. Scheinert and myself, we congratulate St. John's on their enrollment of the first patient in this landmark trial."

About the Moxy Drug Coated Balloon

The Moxy balloon is very similar to a standard angioplasty balloon, but is coated with an anti-restenotic drug designed to help keep arteries open and free from re-blockage.   During the procedure, the Moxy balloon is inflated for 30 seconds during which it open
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SOURCE Lutonix, Inc.
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