FDA Approves Expanded Indication for DCB treatment for Peripheral Artery Disease.
There are few things Robert Canterbury enjoys more than taking his dog, Fearghas, for a walk.
It’s a good workout for both of them.
“I don’t get to rest when I’m walking him,” Robert said. “He drags me right along.”
Not long ago such walks were impossible, at least for Robert.
Pain that started a few years ago as unusual soreness in his legs got much worse over the course of the next 12 months.
Until the day he could barely make it home.
“What should be about a half an hour to 45-minute walk ended up being two and a half to three hours, because I had to stop so often just to let my legs recover. And they hurt. It was incredible. I was almost in tears on the way back,” he said.
Doctors diagnosed Robert with peripheral artery disease, or P.A.D. (Learn more about P.A.D.)
More than 200 million people worldwide suffer from the disease, in which plaque builds up in the arteries. Eventually the plaque can choke off the flow of blood, leaving the legs weak and painful. Untreated, P.A.D. can lead to more advanced and complex problems that can even involve amputation.
In Robert’s case, arteries in both legs were almost completely closed.
At barely 50 years old, he couldn’t exercise and couldn’t work.
Doctors inserted metal stents to re-open Robert’s arteries. But every few months, Robert needed more treatment, because the plaque kept returning, forming in and around the stents. A condition called I.S.R., or In-Stent Restenosis.
“As a physician, you feel frustrated because you want this to be a situation where, when the patient comes in, they get fixed and don’t have to do it again,” said Dr. Qaisar Khan, an interventional cardiologist at Platte Valley Medical Center in Colorado.
After several attempts to keep Robert’s arteries open using traditional therapy, Dr. Khan decided to try a different approach, treating Robert with a Medtronic device called IN.PACT Admiral–a tiny balloon coated with a drug. The balloon is inserted into the artery, inflated to re-open the blockage, and then removed. But unlike traditional therapies, it leaves behind medication designed to slow the re-growth of the plaque.
Almost a year and a half after the procedure, Robert says he still feels like his normal, healthy self. He’s busy remodeling his basement. He’s back at work. And he has not needed more treatment.
“I’ve been in for checkup but that’s all,” he said. “I’ve felt great ever since.”
Dr. Khan was impressed by the results too. He now uses the drug-coated balloon, rather than metal stents, as the primary therapy for other, similar patients. IN.PACT Admiral received FDA approval in September of 2016 for the treatment of ISR.
“In the paradigm of interventional cardiology, I do believe this may be another big breakthrough for delivering therapy,” said Dr. Khan. “Metal may not be the best therapy. So ‘leave nothing behind’ is what we’re thinking may be the way to go in the future.”
Beyond the obvious health benefits, hospital managers like Platte Valley’s Mark Baker say therapies that reduce return trips to the hospital also save money – for the patient, the hospital, the insurance company, and the healthcare system as a whole.
“We’re not using up resources to see people for the same things over and over again. We’re keeping patients out of hospitals and that’s really what we want to do,” Baker said.
For Robert Canterbury, that means a lot more than just a walk in the park.
“The actual feeling of confidence I’ve gotten from knowing that I can go out and do things that I hadn’t been able to do for so long is fantastic.”
Important Safety Information
There are some contraindications for the use of drug-coated balloons, including women who are breast feeding or pregnant, and men or women intending to have children.
Similar to other treatments for PAD, adverse events, although rare, may include, but are not limited to pain, allergic reaction, embolization or perforation of the vessel, gastrointestinal symptoms or blood cell changes.
For full instructions on use of IN.PACT Admiral, please visit http://www.peripheral.medtronicendovascular.com/us/product-type/important-safety-information/index.htm#inpact