A cutting edge technology that has been used successfully in Europe for years has now been approved by the FDA to treat patients with peripheral arterial disease.
It’s the first-ever drug-coated balloon to keep arteries open in patients at high risk for amputations, heart attacks and stroke.
Cardiologists say images make it clear when peripheral arterial disease is in a serious stage.
“Your risk of having a heart attack over five years is about 30 percent and actually one in five people that have peripheral arterial disease will be dead in five years,” Dr. Thomas Mulhearn said.
Peripheral arterial disease, or PAD, is a life-threatening condition affecting one in twenty Americans over the age of 50.
The symptoms start off subtle, but get worse.
“Pain in the legs when you walk or cramping in the buttocks area when you walk, fatigue in the legs, inability to walk a long distance that you were previously able to do. Ulcers that can occur in the feet that are non-healing or wounds that don’t heal in the lower extremities,” Mulhearn said.
PAD treatment starts with lifestyle changes, including diet and exercise.
The next step is to clean the plaque out of the artery and use a stent or balloon to keep it open; something that was just a temporary fix before the introduction of drug-coated balloons.
“Typically in the first six months we see a re-narrowing in the artery after a procedure like this or a stent, but this drug has been specifically developed and this is a really novel technique to prevent that re-narrowing,” Mulhearn said.
Doctors put a tiny roto-rooter type device in to the narrowed artery to remove the plaque.
Next, a drug-coated balloon is inserted.
“It goes in the artery very compressed and then we blow up that balloon and the outside of the balloon is coated with a drug and that drug in this case is called Paclitaxel. That drug is taken up by the wall of the blood vessel and that prevents the re-narrowing of the artery,” Mulhearn said.
The procedure takes one hour and patients typically go home the same day with no more pad pain and a much lower risk for pad-related death.
The Lutonix drug-coated balloon is the only one of its kind approved by the FDA.
Patients must be able to take Aspirin and blood thinners like Plavix in order to be a candidate for this procedure.