Prescriptive Information
Untitled Document
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Indications
The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of Polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation system is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
Contraindications
none
Warnings
- Use of this device in coronary or carotid arteries has not been evaluated.
- Use of this device for stent delivery or stent expansion has not been evaluated.
- Use of this device for non-PTFE access grafts has not been evaluated.
- Do not move the catheter while the warming light is illuminated.
- Treatment at a 1:1 balloon diameter to reference artery ratio is recommended.
- Inflate the PolarCath Catheter only with the PolarCath Inflation Unit. Never use contrast and/or saline to inflate the balloon.
- Do not submerge proximal end of catheter or PolarCath Inflation Unit in water or saline solution.
- The catheter should be deployed while using high quality fluoroscopy. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. Do not place the PolarCath Inflation Unit in direct ionizing radiation, e.g., do not place the PolarCath Inflation Unit under the fluoroscopy head.
- Handle the nitrous oxide cartridges only by the plastic cap.
- Handle only the plug and never the connections that are inserted into the PolarCath Inflation Unit.
Potential Adverse Effects
Possible adverse events include but are not limited to the following:
Allergic reaction to contrast media
Arteriovenous fistula
Death
Embolism
Gas embolism
Hemmorrhage/hematoma
Pain and tenderness
Pseudoaneurysm formation
Pyrogenic reaction
Restenosis of the dilated vessel
Sepsis/infection
Thrombus
Total occlusion
Vessel dissection
Vessel perforation
Cautions
- A thorough understanding of the technical principles, clinical applications, and risks associated with percutaneous transluminal angioplasty is necessary before using this device.
- Only PTFE Arteriovenous (AV) graft material has been tested for compatibility with the PolarCath System. To determine compatibility, testing was conducted to evaluate the tensile mechanical strength of PTFE samples treated with Cryoplasty® Procedure compared to those treated with conventional balloon angioplasty in a simulated environment. No difference was found between the two systems.
- The use of any sheath having a flat metal coil support must be used with caution since exposed metal coils can potentially puncture the balloon.
- Prior to the procedure, the catheter should be examined to ensure that its size and shape are suitable for the specific procedure for which it is to be used.
- Prior to the procedure, systemic anticoagulation should be provided to the patient, as needed.
- Do not reinsert the catheter once it has been removed from the sheath.
Trademark
PEBAX is a trademark of Arkema France Corporation.
