C.R. Bard Shares Global Real-World Registry 24-Month Outcomes for LUTONIX Catheters

C. R. Bard Inc. announced the presentation of the final 24-month results from the LUTONIX Global Real-World Registry at the Vascular Intervention Advances (VIVA) 2016 Meeting. These results are the first reported final 24-month outcomes for “real-word” registry data for drug-coated balloon PTA catheters (DCBs). The registry includes a subgroup of patients with long femoropopliteal lesions (greater than 140 mm) treated with the LUTONIX 035 DCB. A premarket approval supplement for use in this subgroup population is currently under review with the U.S. Food and Drug Administration.
 
In this registry study, the LUTONIX 035 DCB demonstrated a Freedom from Target Lesion Revascularization (TLR) at 24 months by Kaplan-Meier time-to-event analysis of 90.3 percent for the overall study population of 527 patients and 89.4 percent for the long lesion (greater than 140mm) subgroup of 106 patients.
 
Dr. James Benenati, medical director of the peripheral vascular laboratory at Miami Cardiac & Vascular Institute, said, “These 24 month outcomes show the therapeutic durability and safety of the LUTONIX DCB in challenging ‘real world’ patients with complex femoropopliteal artery lesions.”
 
Timothy M. Ring, C.R. Bard’s chairman and CEO, added, “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.”
 
Globally, nearly 202 million patients suffer from PAD, which if untreated could lead to serious complications or even death. According to the American Heart Association, PAD affects nearly 8 million Americans with more than 50 percent of cases involving the femoropopliteal arteries in the legs. Patients with femoropopliteal PAD have reduced blood flow to their lower extremities due to narrowed arteries and carry the risk of amputations, a cause of significant physical and psychological burden to patients and substantial costs to the healthcare system.
 
The LUTONIX 035 DCB is an angioplasty balloon coated with a therapeutic dose of the drug Paclitaxel, which utilizes standard mechanical dilatation to restore blood flow for patients with de novo or restenotic lesions of up to 150 mm in length in native superficial femoral or popliteal arteries. In the United States, use of the LUTONIX 035 DCB in femoropopliteal lesions longer than 150 mm is limited by U.S. law to investigational use.

C. R. Bard Inc., headquartered in Murray Hill, N.J., is a multinational developer, manufacturer and marketer of medical technologies in the fields of vascular, urology, oncology and surgical specialty products.