GORE® PROPATEN® Vascular Graft configured for Pediatric Shunt
The GORE® PROPATEN® Vascular Graft configured for Pediatric Shunt has established a solid reputation for success through:
- Proven thromboresistant surface: CBAS® Heparin Surface offers lasting thromboresistance.1,2
- High performance: Resistance to leakage through the graft wall.
- Clinical experience: More than 10,000 implants worldwide for more than six years.
The GORE® PROPATEN® Vascular Graft configured for Pediatric Shunt is designed to aid in the palliation of cyanotic congenital heart defects in pediatric patients. Our graft delivers optimal performance for these challenging patients, including enhanced thromboresistance via our proprietary CBAS® Heparin Surface. These shunts all feature a thin-walled configuration, which provides kink resistance, improved handling and better tissue approximation for use in neonates.
- Begovac PC, Thomson RC, Fisher JL, Hughson A, Gällhagen A. Improvements in GORE-TEX® Vascular Graft performance by Carmeda® BioActive Surface heparin immobilization. European Journal of Vascular & Endovascular Surgery 2003;25(5):432-437.
- Lindholt JS, Gottschalksen B, Johannesen N, et al. The Scandinavian Propaten® trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial. European Journal of Vascular & Endovascular Surgery 2011;41(5):668-673. OPEN ACCESS https://www.sciencedirect.com/science/article/pii/S1078588411000621
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
INDICATIONS FOR USE: The GORE® PROPATEN® Vascular Graft is intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
CONTRAINDICATIONS: DO NOT use the GORE® PROPATEN® Vascular Graft in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of Heparin-Induced Thrombocytopenia (HIT) type II.
DO NOT use any of the below configurations of GORE® PROPATEN® Vascular Graft for coronary artery bypass or cerebral reconstruction procedures:
- GORE® PROPATEN® Vascular Graft Integrated Rings
- GORE® PROPATEN® Vascular Graft Fixed Ring
- GORE® PROPATEN® Vascular Graft Removable Ring
- GORE® PROPATEN® Vascular Graft Removable Ring Axillobifemoral
DO NOT use GORE® PROPATEN® Vascular Graft as a patch. If cut and used as a patch, GORE® PROPATEN® Vascular Graft may lack adequate transverse strength.
FOR PATCHING APPLICATIONS: For cardiovascular procedures requiring patch materials, use the appropriate GORE-TEX® Cardiovascular Patch.