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FLEXTOME™ Cutting Balloon™ Dilatation Device

Indications, Safety, and Warnings


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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.

Flextome Monorail Cutting Balloon

INTENDED USE/INDICATIONS FOR USE

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)

• Reference vessel diameter (RVD) of 2.00 mm - 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

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.

• 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 a stent cell rather than down the axis of the stent, the deflated Flextome 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 Percutaneous Transluminal Coronary Angioplasty (PTCA). Over sizing 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 advance or retract the catheter unless the balloon is fully deflated under vacuum.

• 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.

• Use only the recommended balloon inflation medium (e.g. contrast medium). Never use air or any gaseous medium to inflate the balloon.

PRECAUTIONS

• The Flextome Cutting Balloon Device should be used only by physicians trained in the performance of Percutaneous Transluminal Coronary angioplasty.

POTENTIAL ADVERSE EVENTS

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

• Embolism

• Arrhythmias, including ventricular fibrillation

• Hypo/hypertension

• Coronary artery spasm

• Hemorrhage or hematoma

• Arteriovenous fistula

• Drug reactions, allergic reactions to contrast medium

• Infections

• Stroke

• Vascular access complications

Flextome Over-the-Wire Cutting Balloon

INTENDED USE/INDICATIONS FOR USE

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)

• Reference vessel diameter (RVD) of 2.00 mm - 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

• 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 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. If the guidewire has passed through a stent cell rather than down the axis of the stent, the deflated Flextome 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 Percutaneous Transluminal Coronary Angioplasty (PTCA). Over sizing 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 advance or retract the catheter unless the balloon is fully deflated under vacuum

• 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.

• Use only the recommended balloon inflation medium (e.g. contrast medium). Never use air or any gaseous medium to inflate the balloon.

PRECAUTIONS

• The Flextome Cutting Balloon Device should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty.

POTENTIAL ADVERSE EVENTS

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

• Embolism

• Arrhythmias, including ventricular fibrillation

• Hypo/hypertension

• Coronary artery spasm

• Hemorrhage or hematoma

• Arteriovenous fistula

• Drug reactions, allergic reactions to contrast medium

• Infections

• Stroke

• Vascular access complications

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