Medtronic lands FDA approval for renal disease treatment

Medtronic (MDT -1.2%) announces FDA approval of the IN.PACT AV drug-coated balloon as a renal disease treatment.

The FDA approval is based on data from a prospective, global, multicenter, blinded, randomized, investigational device exemption study of 330 subjects.

The company says IN.PACT AV increases blood flow and reduces thickening of the vessel wall by delivering the proven anti-proliferative drug paclitaxel.

“The FDA approval of IN.PACT AV DCB marks a significant step forward for paclitaxel-coated devices. Importantly, it allows us to expand our proven IN.PACT DCB platform beyond the superficial femoral artery,” says Medtronic exec Mark Pacyna.

Source: Press Release

https://seekingalpha.com/news/3521268-medtronic-lands-fda-approval-renal-disease-treatment