Medtronic gains FDA approval for IN.PACT 018 DCB

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IN.PACT 018 paclitaxel-coated PTA balloon catheter

Medtronic has announced approval from the US Food and Drug Administration (FDA) for the IN.PACT 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon (DCB), indicated for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries.

“The IN.PACT 018 DCB will allow physicians to better address challenging cases, such as those with narrow lesions or complex anatomies,” said Prakash Krishnan (Icahn School of Medicine at Mount Sinai, New York, USA), who also serves on a scientific advisory board for Medtronic. “The available long-term data [from the IN.PACT Admiral studies] on its benefits gives physicians another effective treatment for PAD in complex anatomies.”

The IN.PACT 018 DCB uses the same drug coating formulation and is built upon equivalent technology to the IN.PACT Admiral DCB, which is compatible with 0.035” guidewires. The IN.PACT 018 DCB is indicated for PTA of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm with vessel diameters of 4‒7 mm. It is engineered to cross tight lesions, provide better deliverability and is compatible with 0.018″ guidewires, Medtronic states in a press release.

The IN.PACT 018 DCB will be the only commercially available DCB with a 200cm over-the-wire (OTW) catheter length, providing physicians the option to treat via femoral or radial access. This is in addition to the to the 130 cm OTW catheter length.

“Medtronic is committed to offering physicians a suite of products to treat patients with PAD. Based on feedback from our clinical community and the need for an 018” guidewire compatible DCB, Medtronic is excited to bring this technology to market in the U.S,” said David Moeller, president of the Peripheral Vascular Health Operating Unit at Medtronic. “The addition of the IN.PACT 018 DCB further reinforces Medtronic’s commitment to being the market leader in drug-coated balloons.”


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