Medtronic scores FDA approval for drug-coated balloon for in-stent restenosis

Medtronic ($MDT) won FDA approval for its drug-coated balloon (DCB) to treat in-stent restenosis (ISR) in patients with peripheral artery disease (PAD). The news is a feather in the company’s cap as it attempts to broaden its lead in the DCB market.

Regulators based their approval on data from the IN.PACT global study, which pitted Medtronic’s IN.PACT Admiral DCB against a standard percutaneous balloon angioplasty.

The study showed that the balloon, which is coated with the drug paclitaxel, had an 88.7% one-year primary patency rate in PAD patients with ISR. The balloon also yielded a 7.3% clinically driven target revascularization rate.


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“We are experiencing a paradigm shift in treating patients with complex PAD,” Dr. John Laird, co-principal investigator for the IN.PACT trial and an interventional cardiologist at the University of California Davis Medical Center, said in a statement. “Until now physicians have had limited treatment options to address patients with ISR. The FDA’s approval of IN.PACT Admiral DCB allows us to treat patients with a durable, proven, and safe technology.”

The regulatory blessing bodes well for Medtronic as it looks to snatch up more of the DCB market. The Dublin-based company got a CE mark for its balloon in 2009 to treat PAD. In 2014, Medtronic got FDA approval for the device to treat superficial femoral and popliteal arteries. So far, the balloon has been used in 100,000 patients.

But Medtronic isn’t content to sit back with the status quo. The company is working to capture other patient groups by laying out promising clinical trial data. In April, Medtronic unveiled two-year study data for the balloon, demonstrating its success in women and people with diabetes.

The company is counting on new applications for the balloon to keep its lead in a rapidly growing market. Medtronic has predicted that the DCB market will be worth as much as $600 million by fiscal year 2018.

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