Indications, Safety and Warnings
Please see Full Prescribing Information in the IFU.
Indications for use
The SLF™* vascular arteriovenous graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theater environment are indicated for use of this device for implantation.
Contraindications
The SLF™* vascular arteriovenous graft should not be used to
perform extra anatomic bypass procedures (e.g., axillofemoral, femoral femoral, and axillobifemoral). These prostheses should not be implanted in patients who exhibit sensitivity to ePTFE. These prostheses should not be implanted in the central circulatory system.
Potential adverse reactions
Potential complications which may occur with any surgical procedure involving a vascular prosthesis include, but are not limited to: bleeding; thrombosis; stenosis; infection, steal syndrome; hemorrhage and/or skin erosion.
For complete details of the SLF™* AV graft, including product and important safety information such as indications, contraindications, warnings and precautions associated with the device and its components, refer to the Medtronic SLF™* spiral laminar flow AV graft IFU (Instructions for Use No. PT00127804).