Medtronic’s In.Pact 018 Drug-Coated Balloon Receives FDA Approval for PAD

May 27, 2022—Medtronic announced that its In.Pact 018 drug-coated balloon (DCB) has received approval from the FDA for the interventional treatment of peripheral artery disease (PAD) in the superficial femoral and popliteal arteries.

The In.Pact 018 DCB is a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter indicated for PTA of de novo, restenotic, and in-stent restenotic lesions with lengths up to 360 mm and vessel diameters of 4 to 7 mm. It is compatible with 0.018-inch guidewires and is intended to cross tight lesions and provide good deliverability, noted Medtronic.

According to the company, the commercially available In.Pact 018 has both a 130-cm over-the-wire (OTW) catheter length as well as a 200-cm OTW catheter length for femoral or radial access.

David Moeller, President of the Peripheral Vascular Health Operating Unit at Medtronic, remarked that the In.Pact 018 DCB is a result of feedback from the clinical community regarding the need for an 0.018-inch guidewire–compatible DCB.

“The In.Pact 018 DCB will allow physicians to better address challenging cases, such as those with narrow lesions or complex anatomies,” commented Prakash Krishnan, MD, FACC, Associate Professor of Medicine, Cardiology, and Radiology at the Icahn School of Medicine at Mount Sinai, in New York, New York. “The available long-term data on its benefits gives physicians another effective treatment for PAD in complex anatomies.” Dr. Krishnan also serves on a scientific advisory board for Medtronic.

In.Pact 018 is built on Medtronic’s In.Pact Admiral DCB technology, which has established safety and effectiveness and has demonstrated strong clinical outcomes, including a high patency benefit through 3 years and low clinically driven target lesion revascularization through 5 years. The company explained that given the design similarities, the IN.PACT clinical program can be considered supportive for the In.Pact 018 DCB, as it has not been evaluated in a clinical study.