Indications, Safety and Warnings
Please see Full Prescribing Information in the IFU.
Indications for use
The Chameleon™ PTA balloon catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon™ PTA balloon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
Contraindications
DO NOT use the Chameleon™ PTA balloon:
- For coronary arteries nor for the delivery and/or expansion of stents.
- In patients who cannot tolerate anticoagulation therapy.
Warnings
Single patient use only. Do not re-use, re-process or re-sterilize.
Potential adverse reactions
Complications from a peripheral balloon dilatation procedure may include:
- Allergic reaction to drugs or contrast medium.
- Aneurysm or pseudo-aneurysm.
- Arrhythmias.
- Embolization.
- Hemorrhage, including bleeding at the puncture site.
- Hypotension/hypertension.
- Inflammation.
- Occlusion.
- Pneumothorax or Hemothorax.
- Sepsis/infection.
- Shock.
- Short term hemodynamic deterioration.
- Stroke.
- Thrombosis.
- Vessel dissection, perforation, rupture or spasm.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
