Bard announces first patient enrolled in Lutonix In-Stent Restenosis Clinical Trial

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C. R. Bard, Inc. (NYSE: BCR) today announced the enrollment of the first patient into the Lutonix(r) In-Stent Restenosis (ISR) Clinical Trial.  Dr. Carlos Mena, Medical Director, Vascular Medicine at Yale - New Haven Hospital, is the principal investigator of the pivotal multi-center randomized Investigational Device Exemption (IDE) trial which is expected to enroll several hundred patients at 30 sites in the U.S.

The study - the first of its kind in the U.S. - will compare the safety and efficacy of the Lutonix(r) 035 Drug Coated Balloon PTA Catheter (DCB) to a standard angioplasty balloon (PTA) for the treatment of femoropopliteal artery in-stent restenosis (SFA-ISR).  ISR is a blockage occurring in a stented vessel and SFA-ISR occurs specifically within the femoropopliteal artery.

SFA-ISR is a common problem, with 20 to 35 percent restenosis rates at 12 months. There are limited treatment options today and the only approved therapy for SFA-ISR in the U.S. is PTA with a bare, non-drug coated balloon. Restenosis rates for PTA are as high as 65 percent at 12 months, driving the desire for a more durable solution.

"With today's treatment limitations, in-stent restenosis remains difficult to treat," said Dr. Mena. "I am excited to lead this groundbreaking study and for the potential to provide the medical community a new tool to treat patients with these complex challenges."

Designed to treat atherosclerotic lesions in the SFA and popliteal arteries, the Lutonix(r) DCB is similar to a standard angioplasty balloon, but is coated with a low dose of the anti-proliferative drug, paclitaxel, with excipients sorbitol and polysorbate.  The combination forms a high-integrity coating adhesion intended to be durable enough to "stick" to the balloon during prep and transit while also allowing release of the drug to the target vessel during a 30-second balloon inflation.  The coating is designed as adjunct therapy to standard mechanical dilatation of the vessel to restore blood flow.  The Lutonix(r) DCB is being studied in the SFA in Levant 2, the first and largest prospective, multi-center, randomized U.S. IDE Trial.
 

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