Ireland-based medical device company Medtronic has received approval from the US Food and Drug Administration (FDA) for its IN.PACT Admiral drug-coated balloon (DCB) as a treatment for in-stent restenosis (ISR) in patients with peripheral artery disease (PAD).
This is the first DCB that has gained approval in the US to treat ISR, and is based on the ISR data from the IN.PACT Global Study compared to a standard percutaneous balloon angioplasty (PTA) control.
U.C. Davis Medical Center interventional cardiologist and co-principal investigator for the IN.PACT SFA trial John Laird said: “We are experiencing a paradigm shift in treating patients with complex PAD.
“Until now, physicians have had limited treatment options to address patients with ISR. The FDA's approval of IN.PACT Admiral DCB allows us to treat patients with a durable, proven, and safe technology.”
ISR occurs when a stent is placed in the artery to restore blood flow but over time plaque can form in and around the stent.
This condition is estimated to occur in up to 40% of all stents placed in the superficial femoral artery (SFA).
Medtronic peripheral business vice-president and general manager 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 US”
The company claims that its IN.PACT Admiral DCB is clinically-proven, cost-effective primary endovascular therapy that enables physicians to treat claudication and restenosis for patients with superficial femoral artery (SFA) disease.
The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, and the proven paclitaxel drug is intended to prevent artery narrowing by minimising scar tissue formation.