UPDATED: FDA approves Medtronic's drug-coated balloon, setting up clash with Bard in new U.S. market

Healthy artery (top) and diseased artery with plaque buildup--Courtesy of Medtronic

The FDA gave PMA approval to Medtronic's ($MDT) IN.PACT Admiral drug-coated balloon for the treatment of peripheral artery disease in the upper leg, making it a competitor to C.R. Bard's ($BCR) recently approved Lutonix 035 balloon.

"The introduction of drug-coated balloons represents a significant breakthrough that might establish a new standard of care with its potential to change the way we treat peripheral artery disease (PAD) in the leg," said Dr. Michael Jaff of Massachusetts General Hospital. He participated in the device's clinical trials.

Approval was expected because those trials found that the patency rates for patients using the drug-coated balloon (DCB) were higher than those receiving conventional percutaneous transluminal angioplasty (82.2% to 52.4%); the DCB patients had a lower rate of lesion revascularization (2.4% compared to 20.6% in the conventional treatment group).

Medtronic explained in an email to FierceMedicalDevices that "patency" refers to "a sustained restoration of adequate blood flow through the treated artery." 

Unlike conventional balloons, the IN.PACT balloon is coated with paclitaxel (like the Lutonix), meaning the device delivers a drug, in addition to physically displacing the plaque buildup that narrows the inside of the vessel via angioplasty.

The IN.PACT Admiral drug-coated balloon in an artery--Courtesy of Medtronic

Medtronic projects the drug-eluting balloon market to be worth as much as $600 million by fiscal year 2018, according to a 2014 analyst presentation.

The approval creates an interesting head-to-head match-up between Bard and Medtronic to determine who gets the majority of the spoils. The market is a new one in the U.S.--the IN.PACT received a CE mark for use in Europe in 2009 and Bard got one for Lutonix in 2012. And keep in mind that many emerging markets recognize the CE mark.

Medtronic says that nearly 100,000 patients have received the IN.PACT so far.

Both company's products are approved to treat PAD in the upper leg; Bard estimates that its indication covers 60% of the 8 million people in the U.S. with PAD. Two other Lutonix drug-coated balloon catheters are available outside the U.S., according to Bard's international product website, including one for coronary conditions. But the company hasn't decided whether to start trials to bring a Lutonix DCB to the U.S. for heart conditions.

Similarly, Medtronic's IN.PACT Pacific drug-coated is also available in Europe to treat to treat atherosclerotic lesions in the superficial femoral and popliteal arteries, which are also treated by the IN.PACT Admiral. In addition, the IN.PACT Falcon is used to treat coronary artery lesions in Europe.   

Bard is holding U.S. trials to expand Lutonix's indication for patients with PAD below the knee, in-stent restenosis, and hemodialysis patients requiring an arteriovenous access point. And John DeFord, Bard's senior vice president of science, technology and clinical affairs, previously told FierceMedicalDevices that the company is applying for additional add-on reimbursement payments for inpatients and outpatients from the Centers for Medicare & Medicaid Services.

Meanwhile Medtronic didn't reveal specific plans to apply for add-on payments, but said in an email, "We're making our best case to the Centers for Medicare & Medicaid Services (CMS) to ensure this device is reimbursed according to the incremental value it adds to the treatment of this disease." 

It says that 450,000 U.S. patients receive surgery to treat PAD in the leg's superficial femoral artery, where the disease strikes most often. Overall, the company estimates that 8 million to 12 million people in the U.S. have PAD.

Meanwhile, in preparation for the looming $43 billion merger with Medtronic, Covidien ($COV) announced in November that it is selling its clinical-stage Stellarex drug-coated angioplasty balloon for PAD to Spectranetics ($SPNC) for $30 million to assuage antitrust concerns.

- read the release

Editor's Note: This article has been updated with additional information provided to FierceMedicalDevices by a Medtronic spokesman.