Yale New Haven Hospital first in New England to use drug-coated balloon to treat vascular disease

Dr. Carlos Mena, director of vascular medicine, YNHH Heart and Vascular Center, showing the first drug-coated angioplasty balloon catheter used on patient with PVD.

Yale New Haven Hospital is changing the management of patients with peripheral vascular disease (PVD). Today, Carlos Mena, MD, director of vascular medicine, YNHH Heart and Vascular Center, deployed the first drug-coated angioplasty balloon catheter into a patient with PVD. The FDA-approved Lutonix® 035 drug-coated balloon (DCB) is used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of PVD.

Drug-coated balloon for treatment of peripheral vascular disease is a new technology that until now was used for coronary artery stenosis. The main use of this technology is in patients with diabetic foot who, otherwise, would have amputation of the limb. During this percutaneous procedure, the doctor inserts the paclitaxel eluting balloon to dilate the artery, no matter if it is a new or recurrent stenosis (re-stenosis). This technology significantly reduces the rate of recurrent stenosis and is more effective over time, compared to the results of standard angioplasty with or without a stent.

"We've been waiting for this technology for a long time," Dr. Mena said. "Today's case will change how we treat PVD."

The Lutonixtrad; 035 DCB is supported by results of the LEVANT 2 pivotal study, a global, prospective, single-blind, randomized, 54-site study (42 sites in the U.S. and 12 in Europe) that enrolled all patients under one protocol. YNHH was among the highest enrolled sites.

PVD affects about eight million Americans. It is a narrowing of arteries in the arm or leg. The risk increases with age, and for people with high blood pressure, high cholesterol, or diabetes. The threat is even greater for smokers. People with PVD are four to five times more likely to suffer a heart attack or stroke. It can also lead to gangrene and amputation.

Dr. Carlos Mena, director of vascular medicine, YNHH Heart and Vascular Center, showing the first drug-coated angioplasty balloon catheter used on patient with PVD.

Yale New Haven Hospital (YNHH), part of Yale New Haven Health, is a nationally recognized, 1,541-bed, not-for-profit hospital serving as the primary teaching hospital for the Yale School of Medicine (YSM). Founded as the fourth voluntary hospital in the U.S. in 1826, today, YNHH has two New Haven-based campuses, and also includes Yale New Haven Children's Hospital, Yale New Haven Psychiatric Hospital and Smilow Cancer Hospital. YNHH has received Magnet designation from the American Nurses Credentialing Center, the nation’s highest honor of nursing excellence. YNHH has a combined medical staff of about 4,500 university and community physicians practicing in more than 100 specialties. www.ynhh.org

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