The Mount Sinai Hospital, New York, is the first in the United States to use the only FDA-approved, drug-coated balloon, the Lutonix® 035 Drug Coated Balloon (DCB) Catheter, to open blocked arteries in the leg.
“I am excited to be first in providing this FDA-approved technology to our peripheral arterial disease (PAD) patients at The Mount Sinai Hospital,” said Prakash Krishnan, MD, FACC, director of endovascular services at Mount Sinai Heart. Krishnan performed the first procedure post-FDA approval on October 11 with Jose Wiley, MD, FACC, and Bhaskar Purushottam, MD, of Mount Sinai. “This drug-coated balloon may be a game changer in the management of patients with peripheral arterial disease. It can effectively reduce the recurrence of blockages in patients, which can help prevent limb amputations, improve a patient’s quality of life, and also be lifesaving.”
The device is used during an angioplasty procedure for patients with PAD who have severely blocked femoropopliteal arteries, major arteries that supply blood throughout the legs. The balloon works to dilate a blocked artery, restoring blood flow to the limb, while administering a therapeutic dose of the drug paclitaxel inside the artery to prevent it from narrowing in the future.
PAD is a life-threatening condition affecting at least 8 million Americans. The condition narrows arteries, reducing blood flow to the limbs. Patients with PAD in their femoropopliteal arteries, especially those older than 50 years of age and those with diabetes, are at increased risk for lower-limb amputation.
“Preventing future artery blockages is as important as opening the initial blockage,” said Krishnan. “This drug-coated balloon technology can help prevent further blockage in the artery.”
This article was adapted from information provided by Mount Sinai Medical Center.