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| C.R. Bard's Lutonix Drug Coated Balloon |
Medtronic ($MDT) and C.R. Bard ($BCR) announced that they have obtained supplemental Medicare reimbursement for peripheral artery disease (PAD) outpatients who are treated using their recently approved drug-coated balloons.
The federal Centers for Medicare & Medicaid Services approved pass-through payments for both of their devices. These bonus payments cover the additional cost to hospitals of treating patients with Medtronic's IN.PACT Admiral or Bard's Lutonix in an outpatient setting.
The payments are also a federal vote of confidence in drug-coated balloons in general, because CMS only approves the payments for new device categories that "substantially improve the diagnosis or treatment of an illness or injury or improve the functioning of a malformed body part compared to all available treatments or diagnostic tests," according its guidelines.
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| The IN.PACT Admiral drug-coated balloon in an artery--Courtesy of Medtronic |
Since the two drug-coated balloons met the clinical bar and are the first devices of their kind in the U.S., they constitute a new category of devices now eligible for pass-through payments that CMS has dubbed (in the dense code of federal agencies), "C2623 (catheter, transluminal angioplasty, drug-coated, non-laser)," Bard says.
The IN.PACT and Lutonix not only physically displace the lesion in the target vessel, similar to traditional angioplasty balloons, but also elute the drug paclitaxel to the artery walls in an attempt to discourage restenosis, or the renarrowing of the artery following surgery. Paclitaxel is also used in drug-eluting stents.
Medtronic says it has also applied for supplemental inpatient reimbursement known as new technology add-on payments. CMS will decide whether to grant the add-on payments over the summer.
Both companies' products are approved to treat PAD in the upper leg. The two bigwigs are aiming to convince the FDA to expand the devices' indication to include patients with PAD below the knee.
Bard recently signed a deal with Boston Scientific ($BSX) to distribute the company's Lutonix DCB in the U.S. as part of a bid to expand the reach of the device, which became the first drug-coated balloon to be approved by the FDA last fall.
There are two other Lutonix drug-coated balloon catheters available outside the U.S., according to Bard's international product website, including one for use in the heart's coronary artery .
FDA approval of Medtronic's IN.PACT followed shortly after the positive Lutonix decision, opening up the new market for fierce competition between the rival devicemakers.
- read the Medtronic release
- read the Bard release