On October 15, 2014, Joseph V. Lombardi, MD, FACS, Head of the Division of Vascular and Endovascular Surgery and Director of the Cooper Aortic Center at Cooper University Health Care, was the first surgeon in New Jersey to treat advanced peripheral arterial disease (PAD) in a patient using the innovative Lutonix® 035 Drug-Coated Balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter. This treatment is the first and only treatment of its kind approved by the U.S. Food and Drug Administration (FDA) to treat PAD, a disease in which plaque builds up in the arteries that carry blood to the head, organs and limbs, creating blockages.
“This is a significant leap forward in the minimally invasive treatment of peripheral vascular disease,” said Dr. Lombardi. “Drug delivery using balloon technology can offer our patients better long term results with same day treatments. We always look forward to offering our patients here at Cooper the very best technology available for the best results.”
The procedure was performed on a 74-year-old man with advanced peripheral arterial disease who potentially faced limb amputation, according to Dr. Lombardi. The minimally invasive procedure was a success and the patient was discharged later in the day.
Millions of Americans suffer from PAD in the femoropopliteal artery. If untreated, PAD can lead to critical limb ischemia (CLI), a severe blockage in the arteries of the legs or feet, and, eventually, even amputation. Recent data shows the majority of all leg and foot amputations in the U.S. are due to vascular disease, including PAD.
Successful treatment of PAD requires improved blood flow (patency) for longer periods of time. Developed by C.R. Bard, the Lutonix 035 DCB uniquely combines an angioplasty balloon coated with a low dose of the drug Paclitaxel to improve blood flow in blocked vessels above the knee.
“Currently, minimally invasive procedures such as angioplasty balloons, stents, atherectomy, medications and vascular bypass surgery are some of the accepted ways to treat PAD, but these options may be limited depending on the type of arterial blockage,” said Dr. Lombardi. The Lutonix 035 DCB is a safe and effective addition to the treatment for PAD in the femoropopliteal artery. Treatment with drug coated balloons (DCBs), also called drug-eluting balloons (DEBs), is similar to standard angioplasty. Unlike standard PTA, however, DCBs also deliver pharmacological treatment to the target lesion and are designed to reduce restenosis and improve patency without leaving a metal stent behind.