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Approval for a rapid exchange version of the cutting balloon. The device, as modified, will be marketed under the trade name cutting balloon monorail and is indicated for dilatation of stenosis in coronary arteries for the purpose of improving myocardial perfusion in those circumstances where a high pressure balloon resistant lesion is encountered. In addition, the target lesion should posses the following characteristics: discrete (<=15 mm in length) or tubular (10 to 20 mm in length); with a reference vessel diameter ranging from 2.0 mm to 4.0 mm; readily accessible to the device; light to moderate tortuosity of proximal vessel segment, non-angulated lesion segment (<45 degrees), smooth antiographic contour; and absence of angiographically-visible thrombus and/or calcification.
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