Dublin-based Medtronic received Food and Drug Administration approval for an expanded indication of its drug-coated balloon.
The IN.PACT Admiral drug-coated balloon can now be used as a treatment for in-stent restenosis in patients with peripheral artery disease. In-stent restenosis occurs when plaque builds up in and around a stent placed in an artery to restore blood flow.
"We are experiencing a paradigm shift in treating patients with complex PAD," said John Laird, MD, interventional cardiologist at UC Davis Medical Center in Sacramento, Calif., and co-principal investigator for a clinical trial on the device. "Until now physicians have had limited treatment options to address patients with [in-stent restenosis]. The FDA's approval of IN.PACT Admiral DCB allows us to treat patients with a durable, proven and safe technology."
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