INTENDED USE/ INDICATIONS FOR USE
The Coyote OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
CONTRAINDICATIONS
None Known.
WARNINGS
- Any use for procedures other than those indicated in these instructions is not recommended.
PRECAUTIONS
- The Coyote OTW PTA Balloon Dilatation Catheter shall only be used by physicians trained in the performance of percutaneous transluminal angioplasty.
- The Coyote OTW PTA Balloon Dilatation Catheter should be used with caution for procedures involving calcified lesions or synthetic vascular grafts due to the abrasive nature of these inflation sites.
- The Coyote OTW PTA Balloon Dilatation Catheters are not intended for injection of contrast medium.
- Precautions to prevent or reduce clotting should be taken when any catheter is used:
- Consider systemic anticoagulation.
- Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use.
- Consult the manufacturers instructions for use when using distal embolic protection devices during angioplasty.
