C.R. Bard (NYSE:BCR) said that data from a 2-year study of its Lutonix drug-coated balloon catheter showed positive results for the device when compared to standard percutaneous transluminal angioplasty.
The 2-year Levant study data showed non-inferiority of the device and a trend towards superiority compared to standard PTA, the company said. Composite safety scores at 24 months were 78.7% for Lutonix, versus 70.9% for standard PTA.
Primary patency, or the rate of lesion reoccurrence, was at 58.6% with Lutonix vs 53% with standard PTA, the study reports. The difference shows a 10.5% relative increase for the Lutonix device over PTA.
The study reported an 82% rate of freedom from target lesion revascularization, or retreatment of the lesion. Rates of death were 6.9%, major amputation at 0.4% and reintervention for thrombosis at 0.4%.
Bard said interim data from a global registry study of its device also showed positive results, reporting a 92% rate of freedom from TLR, a 91% primary patency and 99.1% 30-day safety rate.
The Murray Hill, N.J.-based company also revealed the clinical design of its below-the-knee Lutonix investigational device exemption trial, which it claims is the 1st and only below-the-knee trial of its kind for a drug coated balloon.
Earlier this month, Bard said that the U.S. Centers for Medicare and Medicaid Services had improved the payment for Bard’s Lutonix drug-coated balloon catheter through the Medicare hospital outpatient prospective payment system.