Bard Enrolls First U.S. Patient in Lutonix ISR Clinical Trial

Murray Hill, N.J.-based C.R. Bard Inc. has enrolled the first U.S. patient in its Lutonix In-Stent Restenosis (ISR) clinical trial.

The Lutonix ISR clinical trial is a pivotal, randomized Investigational Device Exemption (IDE) trial in the United States. The multi-center study is designed to compare the safety and efficacy of the Lutonix 035 drug coated balloon percutaneous transluminal angioplasty (PTA) catheter to a standard angioplasty balloon for the treatment of femoropopliteal artery in-stent restenosis.

The study is expected to enroll several hundred patients at 30 U.S. sites. The enrolled patients will be randomized (2:1) for treatment with a Lutonix DCB (study arm), or a standard non-coated angioplasty balloon (control arm). Yale – New Haven Hospital Vascular Medicine medical director Carlos Mena, M.D., is principal investigator of the Lutonix ISR clinical trial.

He said in-stent restenosis remains difficult to treat.

“I am excited to lead this study and for the potential to provide the medical community a new tool to treat patients with these complex challenges,” Mena said.

Lutonix is similar to a traditional angioplasty balloon but is coated with a low dose of paclitaxel, an antiproliferative drug with excipients sorbitol and polysorbate. The drug helps prevent scar tissue from forming around a stent or balloon and also helps keep vessels clear after surgery. 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 30-second balloon inflation, Bard said.

Currently, the Lutonix 035 drug coated balloon PTA catheter is being studied in the SFA in Levant 2, a multi-center, randomized U.S. Investigational Device Exemption trial. The Lutonix ISR trial is designed to produce long-term clinical evidence of the Lutonix DCB in order to expand treatment options for peripheral arterial disease.

Bard has submitted results from the LEVANT 2 trial to the U.S. Food and Drug Administration; the company currently is seeking U.S. approval of the Lutonix DCB. The product is commercially available in Europe.