Only days after the U.S. Food and Drug Administration approved a new device to help open blocked arteries — without the need for a stent — in people suffering from peripheral arterial disease (PAD), doctors at Miami Cardiac & Vascular Institute became some of the first in the country to put it to use on a patient.
That was on Oct. 13, just three days after the FDA approved the first drug-coated “balloon catheter” that essentially inflates to coat a therapeutic dose of a drug directly onto arterial walls in the thigh (superficial femoral arteries), or knee (popliteal arteries), when these arteries are narrowed or blocked as a result of PAD.
On that day, one of the first patients in the nation received the treatment at the Institute.
Shaun Samuels, M.D. [1], an interventional radiologist at Miami Cardiac & Vascular Institute, opted to use the treatment on the patient who had plaque buildup throughout his body, including his thigh. He was an ideal candidate, Dr. Samuels said, because placing a stent would have been potentially riskier in the relatively short segment of artery affected. He had also responded well to initial angioplasty, the common procedure for opening obstructed or narrowed arteries.
Artery Can Heal Safely Without a Stent
The drug coated on the new device helps the artery to heal properly by preventing inflammation and scar tissue, all without the need for a stent to hold the artery open.
Since the FDA’s approval on Oct. 10, up to 10 procedures have been performed on PAD patients at the Institute by interventional radiologists using the drug-coated device.
“This is a promising new technology we have available for our patients,” says James Benenati, M.D. [2], medical director of the Peripheral Vascular Laboratory. “We’ve had very positive outcomes because the drug is delivered effectively into the target area.”
Dr. Samuels said that the drug-coated balloon catheter could prove to be a better option for many patients who don’t react well to a stent, a tiny metal cylinder. Angioplasty with stenting can lead to bleeding, clotting, and other problems.
“The drug that coats the balloon is applied against the wall of the vessel,” says Dr. Samuels. “There is compelling evidence that this is a good technology that doesn’t leave behind any foreign body.”
PAD Can Be Serious If Untreated
Millions of Americans suffer from PAD in the femoropopliteal artery in the thigh. If untreated, PAD can lead to loss of blood flow to the legs or feet, and eventually amputation. Recent data shows the majority of all leg and foot amputations in the United States are due to vascular disease, including PAD. The condition develops most commonly as a result of atherosclerosis, or hardening of the arteries, which occurs when cholesterol and scar tissue build up, forming a substance called plaque.
During a standard angioplasty, a doctor threads a thin tube through a blood vessel to the involved area in the artery. The tube has a tiny balloon on the end. When the tube is in place, the doctor inflates the balloon to push the plaque outward against the wall of the artery. This widens the artery and restores blood flow.
Studies to Determine Long-Term Effectiveness
With the newly-approved LUTONIX 035 drug-coated balloon catheter, a second thin tube is similarly inserted to reopen the artery. The balloon is coated on its outer surface with the drug paclitaxel, which helps prevent recurrent narrowing of arteries after the procedure. The drug-coated balloon technology is only being used at this time for arteries located in the thigh or the knee.
Therapeutic drug levels through the balloon catheter are sustained for several days, and its effects can be evident for months. Studies of up to five years on patients currently undergoing the new procedure will be done to determine a more complete picture of the device’s effectiveness. But short-term results are promising, say Drs. Benenati and Samuels.
“The hope is that it will make people’s lives better,” said Dr. Samuels.
(Picture: The blocked artery (left) is treated with the LUTONIX 035 drug-coated balloon catheter (center), helping the artery heal properly without scarring (right). Click on image to enlarge.)