FDA approves smaller paclitaxel-coated balloon for PAD
The FDA approved a paclitaxel-coated balloon catheter to treat peripheral artery disease in the superficial femoral and popliteal arteries that is compatible with 0.018" guidewires, Medtronic announced.
The IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 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, according to Medtronic. 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 to 7 mm.
It is engineered to cross tight lesions, provide better deliverability and is compatible with 0.018" guidewires, the company stated in a press release.
“The IN.PACT 018 DCB will allow physicians to better address challenging cases, such as those with narrow lesions or complex anatomies,” Prakash Krishnan, MD, FACC, associate professor of medicine, cardiology and radiology at the Icahn School of Medicine at Mount Sinai, said in the release. “The available long-term data on its benefits gives physicians another effective treatment for PAD in complex anatomies."
In addition to the 130-cm over-the-wire catheter length, the IN.PACT 018 DCB will be the only commercially available DCB with a 200-cm over-the-wire catheter length, providing physicians the option to treat via femoral or radial access, according to the release.
“Based on feedback from our clinical community and the need for an 0.018” guidewire-compatible DCB, Medtronic is excited to bring this technology to market in the U.S,” David Moeller, president of the peripheral vascular health operating unit at Medtronic, said in the release.
Medtronic stated that the IN.PACT clinical trial program, which enrolled more than 3,500 participants in 21 studies, can be considered supportive for the IN.PACT 018 DCB, given the design similarities. Additionally, the safety and effectiveness of the 0.035-inch guidewire-compatible IN.PACT Admiral DCB, established in clinical studies performed primarily via femoral access, can be considered supportive for the IN.PACT 018 DCB, according to the company. The IN.PACT 018 DCB has not been evaluated in a clinical study.
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