FDA approves the IN.PACT balloon to treat in-stent restenosis
The FDA approved Medtronic’s IN.PACT Admiral drug-coated balloon Sept. 13 to treat in-stent restenosis in patients with peripheral artery disease.
Medtronic said in a news release that the IN.PACT Admiral was the first drug-coated balloon that the FDA approved to treat in-stent restenosis, which the company said occurs in nearly 40 percent of stents placed in the superficial femoral artery.
The approval was based on results of real-world data from the IN.PACT global study. The one-year primary patency rate for patients with complex in-stent restenosis was 88.7 percent, while the clinically driven target revascularization rate was 7.3 percent. The mean length of lesions was 17.2 cm, and 34 percent were occluded in-stent restenosis lesions.
The FDA approved the IN.PACT Admiral in December 2014 to treat peripheral artery disease. In July, the FDA expanded the drug-coated balloon’s indication to include longer, 150 mm lengths and in four, five and six mm diameters.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.