C.R. Bard (NYSE:BCR) reported 24-month data from its Lutonix Global Real-World Registry, evaluating patients with femoropopliteal lesions treated with the Lutonix drug coated balloon.
The device is an angioplasty balloon coated with a therapeutic dose of paclitaxel. The balloon uses mechanical force to dilate and restore blood flow in patients with lesions up to 150mm in length in superficial femoral or popliteal arteries.
The registry is composed of 527 patients, 106 belonging to a subgroup with femoropopliteal lesions greater than 140 millimeters.
The FDA is considering premarket approval for the Lutonix DCB for this subgroup population.
The Murray Hill, N.J.-based company said that its DCB demonstrated freedom from target lesion revascularization at 24 months in 90.3% of patients in the overall population and 89.4% of patients in the subgroup.
“The Lutonix Global Registry continues to generate strong real-world evidence, confirming the sustained effectiveness of the Lutonix DCB, which provides clinicians with an alternative to treat patients who have peripheral artery disease (PAD) in femoropopliteal arteries,” CEO Timothy Ring said in prepared remarks.
“These 24 month outcomes show the therapeutic durability and safety of the Lutonix DCB in challenging ‘real world’ patients with complex femoropopliteal artery lesions,” Dr. James Benenati of the Miami Cardiac & Vascular Institute added.
The data follows an announcement last week from the company that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease.