Drug-Coated Balloon Gets Expanded Indication for In-Stent Restenosis in PAD


The IN.PACT Admiral drug-coated balloon (DCB) can now be used to treat in-stent restenosis in patients with PAD after the US Food and Drug Administration (FDA) expanded its indications, manufacturer Medtronic announced Tuesday.

That makes the paclitaxel-coated balloon the first such device to carry this indication in the United States.

The new indication was supported by data from the imaging cohort of the IN.PACT Global Study, which compared the IN.PACT Admiral DCB with standard percutaneous balloon angioplasty. At 1 year, the primary patency rate among patients who had been treated for in-stent restenosis was 88.7%, with a clinically-driven TLR rate of 7.3%, according to Medtronic.

On the basis of results from the IN.PACT SFA trial, the balloon was first approved by the FDA in December 2014 to treat superficial femoral and popliteal arteries.

 

Todd Neale is the Associate News Editor for TCTMD and a Senior Medical Journalist. He got his start in journalism at …

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Sources
  • Medtronic. Medtronic receives FDA approval of first drug-coated balloon for treatment of in-stent restenosis (ISR). http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2201572. Published on: September 13, 2016. Accessed on: September 13, 2016.

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