The Wolverine Cutting Balloon Device is indicated for dilation of stenoses in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a balloon resistant lesion is encountered. In addition, the target lesion should possess the following characteristics:
Discrete (< 15 mm in length), or tubular (10 mm to 20 mm in length)
Reference vessel diameter (RVD) of 2.00 mm to 4.00 mm
Readily accessible to the device
Light to moderate tortuosity of proximal vessel segment