CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
Intended Use/Indications for Use:
The WOLVERINE 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 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
- Nonangulated lesion segment (< 45°)
- Smooth angiographic contour
- Absence of angiographically visible thrombus and/or calcification
The WOLVERINE Cutting Balloon Device is contraindicated for use in:
- Delivery through the side cell of a previously placed stent as the deflated Cutting Balloon could become entangled in the stent.
- Coronary artery spasm in the absence of a significant stenosis.
- Exercise extreme care when treating a lesion distal to a stent. When treating lesions at a bifurcation, the 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 Percutaneous Transluminal Coronary Angioplasty (PTCA). To reduce the potential for vessel damage, the inflated diameter of the 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.
- Balloon pressure should not exceed the rated burst pressure.
- The atherotomy process should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication.
- The device should be used only by physicians trained in the performance of PTCA.
- If difficulty is experienced during balloon inflation, do not continue; remove the device and do not attempt to use it. Infusion of any medium other than a flush of heparinized normal saline through the guidewire lumen may compromise device performance
- Do not attempt to reposition a partially deployed balloon.
- Do not use a guidewire having a diameter greater than 0.014 in (0.36 mm).
Potential Adverse Events
Potential adverse events include, but are not limited to, the following:
- Abrupt closure
- Acute myocardial infarction
- Angina or unstable angina
- Arrhythmias, including ventricular fibrillation
- Arteriovenous fistula
- Cardiac tamponade/pericardial effusion
- Cardiogenic shock
- Cerebrovascular accident/stroke
- Coronary aneurysm
- Coronary artery bypass graft surgery
- Coronary artery spasm
- Coronary vessel dissection, perforation, rupture, or injury, possibly requiring surgical repair or intervention
- Drug reactions, including allergic reaction to contrast medium
- Hemodynamic compromise
- Hemorrhage or hematoma
- Minor vessel trauma
- Myocardial ischemia
- Percutaneous re-intervention
- Pseudoaneurysm (at vascular access site)
- Pyrogenic reaction
- Renal failure
- Respiratory insufficiency
- Restenosis of the dilated vessel
- Side branch occlusion
- Slow flow/no reflow
- Total occlusion of the coronary artery or bypass graft
- Transient ischemic attack
- Vasovagal reaction
- Ventricular irritability/dysfunction
- Vessel trauma requiring surgical repair or intervention
- Volume overload