CR Bard has enrolled the first patient in its Lutonix In-Stent Restenosis (ISR) clinical trial, a pivotal multi-centre randomised investigational device exemption (IDE) study in the US.
The pivotal multi-centre randomised IDE trial is expected to enrol several hundred patients at 30 sites throughout the US.
Patients will be randomised (2:1) for treatment with a Lutonix DCB (study arm), or a standard non-coated angioplasty balloon (control arm).
The trial is designed to compare the safety and efficacy of the Lutonix 035 drug coated balloon PTA catheter (DCB) to a standard angioplasty balloon (PTA) for treatment of femoropopliteal artery in-stent restenosis (SFA-ISR).
SFA-ISR is a problem that affects many angioplasty patients, with 20% to 35% restenosis rates at 12 months. The only approved therapy in the US for SFA-ISR is an angioplasty with a bare, non-drug-coated balloon. Restenosis rates with a noncoated balloon are 65% at 12 months.
Yale - New Haven Hospital Vascular Medicine medical director Dr Carlos Mena said with today's treatment limitations, in-stent restenosis remains difficult to treat.
"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," Dr 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. Paclitaxel prevents 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.
The Lutonix DCB is being studied in the SFA in Levant 2, the first and largest prospective, multi-centre, randomised US IDE trial.
CR Bard is one of several studies designed to produce long-term clinical evidence of the Lutonix DCB in order to expand treatment options for peripheral arterial disease.
It submitted results from the LEVANT 2 trial to the FDA but is still seeking approval for the device in the US. The Lutonix DCB is commercially available in Europe.
According to GlobalData estimates, the US PTA Balloons market was valued at $373.8m in 2012 and is expected to grow at a CAGR of 0.9% to reach $397.1m by 2019.
Image: CR Bard headquarters in Providence, Rhode Island, US. Photo: courtesy of haitham alfalah.