Prescriptive Information
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Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Indications
The Flextome Cutting Balloon Device is indicated for dilatation of stenoses 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 possess 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°), smooth angiographic contour; and absence of angiographically-visible thrombus and/or calcification.
Contraindications
- Use of the Cutting Balloon Device is contraindicated in situations where the Cutting Balloon Device would be passed through the side cell of a previously placed stent as the deflated Cutting Balloon Device could become entangled in the stent.
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Coronary artery spasm in the absence of a significant stenosis.
Warnings
- Exercise extreme care when treating a lesion distal to a stent. If the guidewire has passed through the stent cell rather than down the axis of the stent, the deflated Cutting Balloon Device could become entangled in the stent.
When treating lesions at a bifurcation, the Cutting Balloon Device can be used prior to placing a stent, but should not be taken through the side cell of a stent to treat the side branch of a lesion at a bifurcation.
- The Atherotomy process, because of its mechanism of action, may pose a greater risk of perforation than that observed with conventional PTCA. Oversizing increases the risk of perforation. To reduce the potential for vessel
damage, the inflated diameter of the Flextome Cutting Balloon Device should approximate a 1.1:1 ratio of the diameter of the vessel just proximal and distal to the stenosis.
- The Atherotomy process in patients who are not acceptable candidates for coronary artery bypass surgery requires careful consideration, including possible hemodynamic support during the Atherotomy process, as treatment of this patient population carries special risk.
- When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.
- Do not reuse, reprocess, or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure, which, in turn, may result in patient injury, illness or death.
Adverse Effects
Please refer to the Directions for Use for clinical data from the Registry and Global Randomization Trial prior to use of this product.
Potential Adverse Effects
Potential adverse events include, but are not limited to, the following:
- Death
- Acute myocardial infarction
- Total occlusion of the coronary artery or bypass graft
- Coronary vessel dissection, perforation, rupture, or injury
- Aneurysm
- Restenosis of the dilated vessel
- Unstable angina
- Arrhythmias, including ventricular fibrillation
- Hypo/hypertension
- Coronary artery spasm
- Hemorrhage or hematoma
- Arteriovenous fistula
- Drug reactions, allergic reactions to contrast medium
- Infection
- Embolism
- Stroke
- Vascular access complications
