Medicare Approves Drug-Coated Balloons for Outpatient Leg Angioplasty

Lutonix and IN.PACT drug-coated balloons

Last week saw the U.S. Centers for Medicare and Medicaid Services (CMS) approve reimbursement for the two drug-coated balloons that recently were approved by the FDA: C. R. Bard’s Lutonix and Medtronic’s IN.PACT.

C. R. Bard’s Lutonix drug-coated balloon (DCB) was approved in October 2014, while Medtronic’s IN.PACT Admiral was approved in January of this year. Both devices have shown superior results when compared to uncoated balloons (a.k.a. “plain old balloon angioplasty” or POBA).

The reimbursement approval from Medicare is crucial to the success of these medical devices so that patients can actually benefit from them. FDA approval is just the first step; devices are not widely used unless reimbursed by insurance. And while Medicare reimbursement doesn’t guarantee that all insurers will follow suit, that is usually the case.

Being a history nerd, I always look at developments such as these under the category, “Back to the Future.” Because that’s exactly what this is.

Fifty years ago (yes, that’s five-oh) a radiologist in Portland, named Charles Dotter, thought that there was a better way than surgery to open blocked arteries in the leg. And so he invented a series of catheters, each larger than the previous one, and he inserted them, one by one, into blocked superficial femoral arteries, successfully opening the blockages from within. He named this procedure “angioplasty.” Yes, he invented the word.

I discussed this in depth in a previous post (“New Treatment for Peripheral Artery Disease is Approved by the FDA”) but the fact remains that his idea remains “cutting edge” half-a-century later is pretty amazing.

To give you perspective on Dotter’s idea of angioplasty in the leg, I’m posting the first few minutes of his 1965 film, which introduced the concept to physicians around the world, and gave birth to the fields of interventional radiology, interventional cardiology, and endovascular techniques for vascular surgeons. Charles Dotter made the film, he narrates the film, and the patient profiled was his patient — interestingly a surgeon himself!

So enjoy this look back of 50 years and check out the cars, clothing and the “modern radiology suite.”


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Filed under Back to the Future, Endovascular, FDA, Health Insurance, History, Innovators, Peripheral Artery Disease (PAD), Video

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