Product Value—GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Refined value in vascular outcomes
Continued innovation leads to enhanced value with the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. Reducing the number of devices used per case may lead to overall cost savings. Use of the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System has shown to reduce devices per case by 8–23 percent.1
Data shown represents information publicly available by disease state.
Fewer devices per case as well as significantly less total number of SKUs may result in cost savings for treating a broad range of patients.
See why oversizing matters: Potentially stock fewer devices yet treat a broad range of patients.
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INDICATIONS FOR USE: The GORE® TAG® Conformable Thoracic Stent Graft is intended for endovascular repair of all lesions of the descending thoracic aorta, including: isolated lesions in patients who have appropriate anatomy, including adequate iliac/femoral access; aortic inner diameter in the range of 16-42 mm; ≥ 20 mm non-aneurysmal aorta proximal and distal to the lesion, and type B dissections in patients who have appropriate anatomy, including: adequate iliac/femoral access; 20 mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected; diameter at proximal extent of proximal landing zone in the range of 16-42 mm.
CONTRAINDICATIONS: The GORE® TAG® Conformable Thoracic Stent Graft is contraindicated in: patients with known sensitivities or allergies to the device materials; patients who have a condition that threatens to infect the graft.
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
* Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective, observational, multicenter registry to actively track Gore commercial aortic endovascular device performance and associated patient outcomes in global markets with 10 years of follow-up.Results as of June 2017.
† Assumes rounding of measured vessel diameter (mm) to nearest whole number within IFU sizing range for aneurysm.
- W. L. Gore & Associates. Observational Registry Characterizing the Performance and Feature Use of the GORE. TAG. Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System. Bethesda, MD: National Library of Medicine; 2010. Available from: https://clinicaltrials.gov/ct2/show/NCT03286400. NLM Identifier: NCT03286400. Published September 18, 2017. Updated January 7, 2019. Accessed May 13, 2019.
- U.S.Food and Drug Administration.Summary of Safety and Effectiveness Data MEDTRONIC VALIANT Thoracic Stent Graft with the CAPTIVIA® Delivery System. October 26, 2012. Retrieved March 8, 2019 from https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100040S012c.pdf.
- Medtronic Valiant® Thoracic Stent Graft with the Captivia® Delivery System [Instructions for Use]. Santa Rosa, CA: Medtronic Vascular, Inc; 2013. UC201401171 EN 7/13.
- U.S. Food and Drug Administration. Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data (SSED). Valiant Navion™ Thoracic Stent Graft System. P100040/S036. Published October 19, 2018. Accessed June 18, 2020. https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100040S036B.pdf
COOK, ALPHA, TX2 and ZENITH are trademarks of Cook Medical, Inc. MEDTRONIC, CAPTIVA and VALIANT are trademarks of Medtronic, Inc. TERUMO and RELAY are trademarks of Terumo Medical Corporation.