WOLVERINE™ Cutting Balloon Micro-Surgical Dilatation Catheter

Indications, Safety, and Warnings


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

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
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