WOLVERINE™ Cutting Balloon Micro-Surgical Dilatation Catheter

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

CONTRAINDICATIONS

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.

WARNINGS

• 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.

PRECAUTIONS

• 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
• Death
• Drug reactions, including allergic reaction to contrast medium
• Embolism
• Hemodynamic compromise
• Hemorrhage or hematoma
• Hypo/hypertension
• Infection
• 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
• Thrombosis
• 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