C.R. Bard (NYSE:BCR) yesterday released 2-year results from a small group of patients in a real-world registry study of its Lutonix drug-eluting balloon at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco.
Bard said the Lutonix 035 device, which is designed to treat peripheral artery disease, showed a 94.3% rate of freedom from target lesion revascularization in 631 patients at 12 months. A smaller group of 170 patients who were early enrollees in the study showed a 93.0% rate of TLR freedom at 24 months, Murray Hill, N.J.-based Bard said. In June, 2-year data from Bard’s Levant 2 trial showed an 82% TLR freedom rate.
“The final 12-month results of the Lutonix global registry demonstrated how real-world PAD patients with complex and long lesions can benefit from this DEB technology without leaving metal behind. Also encouraging are the interim 24-month results which suggest durable benefits of the Lutonix DCB,” Dr. Dierk Scheinert of the University of Leipzig in Germany said in prepared remarks.
“I would like to thank all of the investigators who participated in the Lutonix global registry, which continues to generate strong real-world evidence, providing clinicians with an effective alternative to treat their patients who have PAD in femoropopliteal arteries,” added Bard chairman & CEO Timothy Ring.