Peripheral Cutting Balloon™

Indications, Safety and Warnings

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Prescriptive Information

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.

2cm Peripheral Cutting Balloon

INTENDED USE/INDICATIONS FOR USE

The Peripheral Cutting Balloon catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

CONTRAINDICATIONS

  • Use of the Cutting Balloon Device is contraindicated in situations where the Cutting Balloon Device would be passed through the struts of a previously placed stent as the deflated Cutting Balloon Device could become entangled in the stent.
  • The Peripheral Cutting Balloon Device is not for use in the coronary arteries or carotid arteries.
  • The Peripheral Cutting Balloon Device is not intended for the expansion or delivery of stents.

WARNINGS

  • The Cutting Balloon Device should be used before new stent placement. Exercise extreme care when treating a lesion distal to a previously placed 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. Confirm wire position in two views before advancing the Cutting Balloon Device if crossing a previously placed stent. Excessive withdrawal pressure against resistance can damage the Device and potentially require surgery for retrieval. 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 where a stent has been previously placed.
  • Angioplasty with the Peripheral Cutting Balloon Device, because of its mechanism of action, may pose a greater risk of perforation than that observed with conventional PTA. Oversizing increases the risk of perforation. To reduce the potential for vessel damage the inflated diameter of the Peripheral Cutting Balloon Device should not exceed a 1.1:1 ratio of the diameter of the vessel just proximal and distal to the stenosis.
  • Balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99.9% of the balloons, (with a 95% confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization.
  • Use only the recommended balloon inflation medium (e.g. - contrast medium). Never use air or any gaseous medium to inflate the balloon.
  • Do not use in a kinked or buckled introducer sheath or if resistance is encountered. Resistance, kinking, or buckling in the introducer sheath may damage the atherotomes or balloon. If any of these occur, immediately withdraw both devices.
  • 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. If resistance is met during manipulation, determine the cause of the resistance before proceeding.

PRECAUTIONS

Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used. Only physicians who have received the appropriate training should use the Peripheral Cutting Balloon Device. During the Peripheral Cutting Balloon Device procedure, appropriate anticoagulant therapy should be provided to the patient. Anticoagulant therapy should be continued after the procedure for a period of time to be determined by the physician. The Peripheral Cutting Balloon Device is not designed for, and therefore, cannot be used to monitor in vivo arterial pressures.

POTENTIAL ADVERSE EVENTS

Risks associated with interventional treatment of stenosis with the Peripheral Cutting Balloon Device are similar to those of conventional PTA. Potential risks include, but are not limited to:

  • Allergic or drug reaction (device material, contrast medium and medications)
  • Amputation
  • Arteriovenous fistula
  • Death
  • Embolism
  • Hematoma
  • Hemorrhage
  • Hypotension/hypertension
  • Infection/Sepsis
  • Ischemia/infarction of tissue/organ
  • Pain
  • Pseudoaneurysm
  • Restenosis
  • Surgical intervention
  • Swelling
  • Thrombosis
  • Vessel injury (dissection, perforation, or rupture)
  • Vessel occlusion
  • Vessel spasm

Small Peripheral Cutting Balloon

INTENDED USE/INDICATIONS FOR USE

The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

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.
  • The Peripheral Cutting Balloon Device is not for use in the carotid arteries.
  • The Peripheral Cutting Balloon Device is not intended for the expansion or delivery of stents.

WARNINGS

  • The Cutting Balloon Device should be used before new stent placement. Exercise extreme care when treating a lesion distal to a previously placed 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. Confirm wire position in two views before advancing the Cutting Balloon Device if crossing a previously placed stent. Excessive withdrawal pressure against resistance can damage the Device and potentially require surgery for retrieval. 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 where a stent has been previously placed.
  • PTA with the Peripheral Cutting Balloon® Device, because of its mechanism of action, may pose a greater risk of perforation than that observed with conventional PTA.
  • Oversizing increases the risk of perforation. To reduce the potential for vessel damage the inflated diameter of the Peripheral Cutting Balloon Device should not exceed a 1.1:1 ratio of the diameter of the vessel just proximal and distal to the stenosis. • Balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99.9% of the balloons, (with a 95% confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization.
  • Use only the recommended balloon inflation medium (e.g.- contrast medium mixed with saline). Never use air or any gaseous medium to inflate the balloon.
  • Do not use in a kinked or buckled introducer sheath or if resistance is encountered. Resistance, kinking, or buckling in the introducer sheath may damage the atherotomes or balloon. If any of these occur, immediately withdraw both devices.
  • 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. If resistance is met during manipulation, determine the cause of the resistance before proceeding.

PRECAUTIONS

  • Prior to PTA, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.
  • Only physicians who have received the appropriate training should use the Peripheral Cutting Balloon Device.
  • During the Peripheral Cutting Balloon Device procedure, appropriate anticoagulant therapy should be provided to the patient. Anticoagulant therapy should be continued after the procedure for a period of time to be determined by the physician.
  • The Peripheral Cutting Balloon Device is not designed for, and therefore, cannot be used to monitor in vivo arterial pressures. 

POTENTIAL ADVERSE EVENTS

Risks associated with interventional treatment of stenosis with the Peripheral Cutting Balloon Device are similar to those of conventional PTA. Potential risks include, but are not limited to:

  • allergic or drug reaction (device material, contrast medium and medications)
  • amputation
  • arteriovenous fistula
  • death
  • embolism
  • hemorrhage
  • hematoma
  • hypotension/hypertension
  • infection/sepsis
  • ischemia/infarction of tissue/organ
  • pain
  • pseudoaneurysm
  • restenosis
  • surgical intervention
  • swelling
  • thrombosis
  • vessel injury (dissection, perforation, or rupture)
  • vessel occlusion
  • vessel spasm
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