Medtronic has secured approval from the US Food and Drug Administration (FDA) for its IN.PACT Admiral drug-coated balloon (DCB) to treat in-stent restenosis (ISR) in patients with peripheral artery disease (PAD).
The approval was based on ISR data from the IN.PACT global study, which compared the IN.PACT Admiral balloon against standard percutaneous balloon angioplasty (PTA) control.
The IN.PACT DCB is a primary endovascular therapy, which allows physicians to treat claudication and restenosis for patients with superficial femoral artery (SFA) disease.
Its primary mode of action is physical dilatation of the vessel lumen by PTA, while the paclitaxel drug will prevent artery narrowing by minimizing scar tissue formation.
In 2009, the company secured CE mark approval for IN.PACT Admiral DCB to treat PAD. In 2014, it received FDA approval to treat superficial femoral and popliteal arteries
Medtronic aortic and peripheral vascular division’s peripheral business general manager and vice president Mark Pacyna said: "Prior to the FDA approval of IN.PACT Admiral DCB for ISR, physicians were challenged to find a durable treatment for PAD patients, considering the complexity of the disease.
“Together, in collaboration with physicians in the vascular clinical community, we designed the IN.PACT Global Study to look at challenging lesions in real-world patients.
“Today, the IN.PACT Admiral DCB has demonstrated consistent outcomes across all patient morphologies, and it is the only DCB approved to treat patients with ISR in the U.S."