Medical Devices: Evidence and Research (Feb 2019)
IN.PACTTM AdmiralTM drug-coated balloons in peripheral artery disease: current perspectives
Abstract
Sho Torii, Frank D Kolodgie, Renu Virmani, Aloke V Finn Cardiovascular Pathology, CVPath Institute, Inc., Gaithersburg, MD, USA Abstract: Endovascular therapy has evolved as a main treatment option especially in patients with short (<25 cm) femoropopliteal lesion. The latest guideline recommends the use of drugeluting devices (both drug-coated balloons [DCBs] and drug-eluting stents) in short femoropopliteal esions as class IIb recommendation. DCB usage is also recommended for in-stent restenosis lesions (class IIb). DCBs are a more attractive treatment option because the lack of metal prosthesis allows for more flexibility in future treatment options including the option of treating nonstenting zones, previously DCB-treated zones with DCBs again. The IN.PACT™ Admiral™ DCB has shown promising clinical performance in several randomized control trials and global registries, and is currently the market DCB leader for the treatment of femoropopliteal lesions with more than 200,000 patients treated thus far. Currently, more than 10 DCBs have received Conformité Européene mark for the treatment of femoropopliteal atherosclerotic disease. Three of these (including IN.PACT Admiral DCBs) have also received Food and Drug Administration approval in the USA. However, some Conformité Européene-marked DCBs have failed to show consistent results in their clinical studies suggesting all DCBs are not created equal. Each DCB is unique (ie, drug type, drug dose, crystallinity, and excipient) with different clinical outcomes. In the current review, we will focus on the preclinical and clinical results of not only IN.PACT Admiral DCB, but also the other currently available DCBs. Keywords: drug-coated balloon, superficial femoral artery, percutaneous transluminal angioplasty, peripheral artery disease, drug-eluting stent, critical limb ischemia
