Medtronic has secured approval from the US Food and Drug Administration (FDA) for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).
Image: Medtronic operational headquarters. Photo: courtesy of Medtronic.
The IN.PACT Admiral DCB is a primary endovascular therapy, which allows physicians to treat claudication and restenosis for patients with SFA disease..
It is claimed to be the first DCB to secure FDA approval for the treatment of in-stent restenosis and lesions up to 360mm in length.
In April this year, the firm secured approval for the treatment of SFA up to 360mm in length.
The approval was granted based on clinical data from the complex lesion imaging cohorts of the IN.PACT global study, including long lesion, in-stent restenosis, and chronic total occlusion (CTO) groups with lesion lengths greater than 180mm.
According to the company, complex lesions with over 150mm length are commonly encountered in clinical practice and remain a significant treatment challenge for physicians.
Medtronic cardiac and vascular group’s peripheral business vice president and general manager Mark Pacyna said: “In our IN.PACT Global Study, IN.PACT Admiral demonstrated safety and effectiveness in real-world patients with complex lesions, including long lesions.
“Our new long lesion indication – coupled with the approval of the 200mm and 250mm balloons -furthers our commitment to the clinical community by equipping them with the tools and evidence needed to effectively treat complex cases.”
Initially, the DCB will help in the physical dilatation of the vessel lumen with the support of PTA. It will be followed by the delivery of paclitaxel.
With a unique dose and excipient, IN.PACT Admiral DCB will help to avoid artery narrowing by minimizing scar tissue formation.
In 2009, IN.PACT Admiral secured CE mark approval for the treatment of PAD. In December 2014, the DCB secured FDA approval to treat superficial femoral and popliteal arteries.