C.R. Bard (NYSE:BCR) said yesterday 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.
Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the knee. The Lutonix devices are designed to elute the anti-stenosis drug paclitaxel as the balloon is inflated to dilate narrowed arteries.
The federal safety watchdog approved a 6-month safety endpoint of freedom from major adverse limb event or post-operative death at 30 days for the new, 500-patient single-arm study evaluating the Lutonix 014 device, Bard said. The primary efficacy endpoint is a composite of limb salvage and primary patency at 6 months, the company said. Some 340 patients are already enrolled in the trial, Bard said.
“Below the knee PAD is a challenging disease in a patient group that is currently under served. Patients often have to undergo frequent re-interventions following initial treatment. Regular balloon angioplasty is the primary catheter-based treatment option available today,” Dr. Michael Jaff, of the VasCore vascular ultrasound core lab used in the Lutonix BTK trial, said in prepared remarks.
“A significant number of patients with BTK disease are at risk of limb loss and would be expected to benefit from alternative treatment options. The Lutonix 014 DCB could offer physicians an opportunity to change the treatment paradigm for patients by providing a safe and effective method to deliver paclitaxel directly to stenosed BTK vessels,” added principal investigator Dr. Jihad Mustapha.