Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter.
Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries.
According to a news release, In.Pact 018 uses the same drug coating formulation as — and was built upon equivalent technology to — the In.Pact Admiral DCB. The In.Pact 018 will be used for PTA of de novo, restenotic or in-stent restenotic lesions with lengths up to 360 mm with vessel diameters of 4-7 mm.
Medtronic designed In.Pact 018 to cross tight lesions and provide better deliverability. It features compatibility with 0.018″ guidewires and will be the only commercially available DCB with a 200 cm over-the-wire (OTW) catheter length, giving physicians the option of femoral or radial access for treatment, Medtronic said.
“The In.Pact 018 DCB will allow physicians to better address challenging cases, such as those with narrow lesions or complex anatomies,” scientific advisory board member and associate professor of medicine, cardiology and radiology at the Icahn School of Medicine at Mount Sinai Dr. Prakash Krishnan said in the release. “The available long-term data on its benefits gives physicians another effective treatment for PAD in complex anatomies.”
The company said more than 3,500 patients in 21 clinical studies, plus more than 500,000 patients treated worldwide, demonstrate the strong clinical outcomes for the In.Pact Admiral DCB and, given the design similarities, such data can be considered supportive for the In.Pact 018 DCB, including safety and effectiveness data established in clinical studies.
In.Pact 018 has not been evaluated in a clinical study, the company said.
“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,” President of Medtronic’s peripheral vascular health operating unit David Moeller said. “The addition of the In.Pact 018 DCB further reinforces Medtronic’s commitment to being the market leader in drug-coated balloons.”