FDA Approves Medtronic’s In.Pact 018 Drug-Coated Balloon Catheter

In.Pact 018 DCB from Medtronic. [Image from Medtronic]

Medtronic (NYSE: MDT) announced that it has received FDA clearance 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, has received an indication for the interventional treatment of peripheral arterial disease (PAD). ) in the superficial femoral and popliteal arteries.

According to a press release, In.Pact 018 uses the same drug coating formulation as – and was built on equivalent technology – In.Pact Admiral DCB. The In.Pact 018 will be used for ATP of de novo restenotic, restenosic or in-stent lesions with lengths up to 360mm with vessel diameters of 4-7mm.

Medtronic designed In.Pact 018 to cross tight lesions and provide better deliverability. It is compatible with 0.018″ guidewires and will be the only commercially available DCB with an over-the-wire (OTW) catheter length of 200cm, giving physicians the option of femoral or radial access for treatment. , Medtronic said.

“The In.Pact 018 DCB will allow physicians to better treat difficult cases, such as those with narrow lesions or complex tomies,” said the Scientific Advisory Board member and Associate Professor of Medicine, Cardiology and Radiology at the Icahn Medical School at Mount Sinai. Prakash Krishnan said in the statement. “The available long-term data on its benefits provide physicians with another effective treatment for PAOD in complex autonomies.”

The company said more than 3,500 patients in 21 clinical studies, as well as more than 500,000 treated patients worldwide, demonstrate the strong clinical results of the In.Pact Admiral DCB and, given the design similarities, these data can be considered favorable to In.Pact. 018 DCB, including safety and efficacy data established in clinical studies.

In.Pact 018 has not been evaluated in a clinical study, the company said.

“Medtronic is committed to providing physicians with a suite of products to treat patients with PAD. Based on feedback from our clinical community and the need for a DCB compatible with the 018 guidewire, Medtronic is excited to bring this technology to market in the United States,” said Vascular Health Business Unit President Medtronic Device, David Moeller “The addition of the In.Pact 018 DCB further reinforces Medtronic’s commitment to being the market leader in drug-coated balloons.”