product
GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System
The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease.
Products presented on this platform may not be available in all markets. Please refer to our website www.goremedical.com for more information.
Why to use it
An innovative stent graft and delivery system designed to treat patients that may have previously been excluded due to challenging proximal aortic necks, the GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System was engineered to deliver unmatched angulation, controlled conformability, and precise placement.
Together with GORE® EXCLUDER® AAA Endoprosthesis featuring C3® Delivery System, the GORE® EXCLUDER® Device family now allows physicians to treat the widest range* of AAA anatomies, choosing the best solution for each patient.
*GORE® EXCLUDER® Conformable AAA Endoprosthesis with ACTIVE CONTROL System: Infrarenal aortic neck treatment diameter range of 16–32 mm; minimum aortic neck length of 10 mm when proximal aortic neck angulation is ≤ 60˚; minimum aortic neck length of 15 mm when proximal aortic neck angulation is ≤ 90˚. GORE® EXCLUDER® AAA Endoprosthesis: Infrarenal aortic neck treatment diameter range of 19 – 32 mm treatment range and a minimum aortic neck length of 15 mm; Proximal aortic neck angulation ≤ 60°.
Instructions for use
Characteristics
This innovative, new device provides the opportunity to expand EVAR capabilities and offer the quality advantages of minimally invasive repair to more patients that may have been previously excluded, or treated surgically. It has the broadest patient indication range* for abdominal endovascular aneurysm repair.
Patient benefits
• Less invasive treatment may allow for faster recovery time and reduced length of hospital stay
• In general, reduced procedural time means decreased fluoroscopy time, radiation exposure(1), (2), and contrast(3), as well as less anesthesia administered
Physician benefits
• Ability to treat more patients due to expanded treatment range
• Ability to angulate and achieve seal may decrease endoleaks
Financial benefits
• Designed for complex anatomies, built on the durable outcomes of GORE® EXCLUDER® AAA Endoprosthesis
• Possible reduction in OR case time can improve efficiency and may contribute to positive margins with faster room turnover(4)
* Infrarenal aortic neck treatment diameter range of 16–32 mm; minimum aortic neck length of 10 mm when proximal aortic neck angulation is ≤ 60˚; minimum aortic neck length of 15 mm when proximal aortic neck angulation is ≤ 90˚.
1. Lee JT, Lee GK, Chandra V, Dalman RL. Comparison of fenestrated endografts and the snorkel/chimney technique. Journal of Vascular Surgery 2014;60(4):849-857. http://www.sciencedirect.com/science/article/pii/
S0741521414006697?via%3Dihub
2. U.S. Food and Drug Administration Web site. Radiation-emitting products. Fluoroscopy. Benefits and risks. https://www.fda.gov/radiationemittingproducts/radiationemittingproductsandprocedures/medicalimaging/medicalx-rays/ucm115354.htm#benefitsrisks Updated March 2, 2017. Accessed September 28, 2017. Accessed September 23, 2017.
3. Kothandan H, Haw Chieh GL, Khan SA, Karthekeyan RB, Sharad SS. Anesthetic considerations for endovascular abdominal aortic aneurysm repair. Annals of Cardiac Anaesthesia 2016;19(1):132-141. https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC4900395/.
4. Gamble M. 6 cornerstones of operating room efficiency: best practices for each. Becker’s Healthcare Web site. https://www.beckershospitalreview.com/or-efficiencies/6-cornerstones-of-operating-room-efficiency-best-practices-for-each.html Published January 18, 2013. Accessed September 28, 2017.