References:
* 38 out of 38 surgeons surveyed agreed.
** Preclinical results may not correlate with clinical performance in humans.
† Benchtop test results may not necessarily be indicative of clinical performance.
†† Benchtop testing in porcine tissue ≤ 30 mm Hg (26 mm Hg average pressure experienced during intraoperative leak test), comparing TRIEEA31XT to Ethicon™* CDH29A (n = 20; P = 0.009).
††† Compared to EEA™ circular staplers with DST Series™ technology.
‡ Instances of tissue sticking to jaws measured over 110 seals per device.
‡‡ 29 out of 29 surgeons evaluated agreed
‡‡‡ Results may not correlate to performance in humans
§ Based on cadaver usability lab with 16 surgeons (13 of 16 surgeons agreed). The two devices are: a standard trocar and a fascial closure system. Preclinical results may not correlate with clinical performance in humans
§§ Based on surgeon/customer validation. In several clinical investigations, the median times to hemostasis were within 1 - 1.5 minutes
- Based on internal test report #RE00024826 rev D, Signia™ stapling system summative usability report. September 2016.
- Based on internal test report #R2146-173-0, ASA verification testing with slow speed force limit evaluation. 2015.
- Based on internal test report #R2146-151-0, Powered stapling firing speed DOE analysis and ASA parameters. 2015.
- Based on internal report #RE00055515, Sages Lab report. August 2016.
- Based on internal report #RE00318260, Comparative leak testing for EEA™ circular stapler with Tri-Staple™ technology and Ethicon™* CDH. April 2021.
- EEA™ circular staplers instructions for use
- Based on internal report #RE00457416 Rev A, Product introduction report: LigaSure™ XP Maryland jaw sealer/divider. May 2023.
- Based on internal test report #RE00329878 rev A, Marketing evaluation of surgeon experience using the Sonicision™ 7 curved jaw cordless ultrasonic dissector. Apr. 14–15 and 20-22, 2021.
- Based on internal validation report #RE00098009 Rev A, Double Time VersaOne™ fascial closure system Miami lab VOC (3/28). March 28, 2017
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- Based on internal report #COVEULV0032, A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant TachoSil™* in Subjects undergoing Hepatic Surgery, appendix B. January 2012.
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- N. J. Smart, N. Bryan, J. A. Hunt. A scientific evidence for the efficacy of biologic implants for soft tissue reconstruction. First published: 08 November 2012; Special Issue: Biologic Meshes in Colorectal Surgery. Volume 14, Issue Supplement s3, pages 1–6, December 2012.|https://doi.org/10.1111/codi.12042.
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- Procedural solutions box business case 16-weu-custom-procedure-kits-business-case-870893