Powered staplers

Signia™ circular stapler with Tri-Staple™ technology

<p>A circular stapler that combines Signia™ intelligence, Adaptive Compression™ technology, and Tri-Staple™ reloads to empower anastomotic performance.</p>

Features

Circular stapling innovation

Explore all the advantages the Signia™ circular stapler can bring to your surgical procedures.

Software updates

Ask your Medtronic sales representative about the most recent software updates.


Frequently asked questions

The Signia™ stapler, when used with the Signia™ circular adapter and Tri-Staple™ 2.0 circular single-use reloads, has applications throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries. The intended purpose of the device is creation of anastomosis. Refer to instructions for use (IFU) for appropriate clinical use.

The Signia™ circular stapling system provides several functionalities you won’t find with any other circular stapler.

  • It’s the only circular stapler with powered and intelligent clamping to control compression.††,12,13
  • It’s the only circular stapler that allows the user to leak-test the staple line without removing the instrument from the lumen.††,‡‡,14
  • It’s the only circular stapler that separates staple and cut functions, confirming staple line formation before engaging the knife.††,12,13

Plus, the system allows you to select from an array of device components to meet your needs, from reusable circular adapters to multiple single-use reload sizes to procedure-specific options.

Adaptive Compression™ technology is designed to give you the feedback you want throughout clamping and firing.1,2 It works in conjunction with the Signia™ stapling system to:

  • Determine the compression profile (i.e., proper speed and pressure) based on tissue properties and thickness3
  • Use tissue-sensing technology to measure and adapt the amount of applied pressure1,2,12
  • Notify you when tissue relaxation occurs, when the staple line is complete, and when the knife blade engages2,15

With this built-in intelligence to control compression,3 you may avoid overcompressing the tissue§§,◊◊,2,5,13 and prevent damage to the anastomosis.◊◊,16

The Signia™ circular stapler uses a Tilt-Top™ anvil, which tilts to facilitate easier removal from the anastomotic site.¶¶,17,18

The Signia™ circular stapler produces 88% less waste than the Echelon Circular™* powered stapler.##,19 It also provides greater protection against anastomotic leaks¶,8 — and procedures where no anastomotic leaks occur are associated with a shorter length of stay and lower costs when compared to procedures with anastomotic leaks.20

Ordering information

Product code Description Units per box
SIGPHANDLE Signia™ power handle 1
SIGPSHELL Signia™ power shell 1
SIGSBCHGR Signia™ single-bay charger 1
SIGRIG Signia™ reusable insertion guide 1
SIGMRET Signia™ manual retraction tool 1
SIGTRAY Signia™ sterilization tray 1
SIGCIRSTND Signia™ circular adapter (standard length) 1
SIGCIRXL Signia™ circular adapter (XL length) 1
SIGCIR28MT Circular reload with Tri-Staple™ technology 28 mm reload, medium/thick
SIGCIR28XT Circular reload with Tri-Staple™ technology 28 mm reload, extra thick
SIGCIR31MT Circular reload with Tri-Staple™ technology 31 mm reload, medium/thick
SIGCIR31XT Circular reload with Tri-Staple™ technology 31 mm reload, extra thick
SIGCIR33MT Circular reload with Tri-Staple™ technology 33 mm reload, medium/thick
SIGCIR33XT Circular reload with Tri-Staple™ technology 33 mm reload, extra thick

Potential complications may include but are not limited to unspecified infection, hypersensitivity/allergic reaction, fistula, failure to anastomose, hemorrhage/blood loss/bleeding, peritonitis, sepsis, hemothorax, bowel burn, ischemia, stenosis, foreign body in patient, perforation, bowel perforation, environmental contamination, gastro-intestinal obstruction/occlusion, tissue breakdown.

TM* Third-party brands are trademarks of their respective owners.

† Bench test results may not necessarily be indicative of clinical performance. Compared to EEA™ circular staplers with DST Series™ technology (EEA2835, p < 0.001, n = 5), Ethicon™* CDH (CDH29A n = 9 , p < 0.001, n = 5 for SIGCIR, for CDHA), and Ethicon Echelon Circular™* powered stapler (Ethicon™* CDH29P, p < 0.001, n = 5).

‡ Based on survey results from trained surgeons using Signia™ circular stapler. 14 out of 16 surgeons agree.

§ Based on survey results from trained surgeons using Signia™ circular stapler in regards to circular anastomosis creation. 16 out of 16 surgeons agreed.

◊ Compared to the Ethicon Circular™* powered stapler in an in vivo benchtop comparison (CDH31P: n = 13; SIGCIR31XT: n = 9, p = 0.043). Results may not correlate with clinical performance in humans.

¶ Preclinical results may not correlate with clinical performance in humans. Based on leak testing in an in vivo canine model comparing SIGCIR25XT to CDH25P (n = 9; p = 0.007).

# Based on survey results from trained surgeons comparing CDH31P to SIGCIR31XT (n = 15, p = 0.008).

∆ Based on survey results from trained surgeons using Signia™ circular stapler. 16 out of 16 surgeons agreed.

∞ The Signia™ circular stapler allows 164% greater perfusion into the staple line than the Echelon Circular™* powered stapler, which may facilitate better wound healing at the anastomotic site. Compared to the Ethicon Circular™* powered stapler in an in vivo benchtop comparison (CDH31P: n = 13; SIGCIR31XT: n = 9, p = 0.043). Results may not correlate with clinical performance in humans.

†† As of January 2024.

‡‡ For 28, 31, and 33 mm sizes only.

§§ Compared to manual clamping circular staplers, p < 0.001, n = 5 for SIGCIR, n = 9 for TriEEA.

◊◊ Bench test results may not necessarily be indicative of clinical performance.

¶¶ Compared to a circular stapler with a fixed anvil. Preclinical results may not correlate with clinical performance in humans. Based on removal force testing in an ex vivo canine model (n=14, p = 0.000).

## Total waste based on device component weights and expected circulation ratio of each component on a per-procedure basis comparing CDH31P to the Signia™ circular stapler with a 31 mm Tri-Staple™ reload (n = 3, p < 0.001).

  1. Signia™ stapler [user manual]. North Haven, CT: Medtronic; 2023.
  2. Based on report RE00052285 rev W, Gen II Power Pack EEA™ stapler application SRS. Oct 2023.
  3. Based on internal test report #RE00258180, Memo — Signia™ power EEA™ clamping. Oct 2023.
  4. Based on internal report #RE00124842 rev C, Signia™ circular stapling system (PEEA) summative usability. Sept 2019.
  5. Based on internal test report RE00185349 rev.1, Tissue clamp benchmark vs. manual instruments (Tulip, DST™, & Ethicon™*). Nov 2023.
  6. Based on internal test report RE00350454, Compression testing for powered CDH 29mm product. Sept. 13, 2021.
  7. Based on internal report RE00480654, PEEA post-summative lab user questionnaire. October 2023.
  8. Based on internal test report RE00330708 rev.1, PCG-42: Perfusion analysis for circular staplers. May 13, 2021.
  9. Based on internal test report RE00470656 rev.0, Comparative in vivo leak testing. July 2023.
  10. Based on internal test report RE00394109 rev. 0, Distal tip motion and user feedback for circular staplers: EEA™ with Tri-Staple™, Signia™ circular with Tri-Staple™, and Ethicon™* Echelon™* circular powered stapler. October 2023.
  11. Blanco-Colino R, Espin-Basany E. Intraoperative use of ICG fluorescence imaging to reduce the risk of anastomotic leakage in colorectal surgery: a systematic review and meta-analysis. Tech Coloproctol. 2018;22(1):15–23.
  12. Smallwood N, Mutch MG, Fleshman JW. The failed anastomosis. In: Steele SR, Maykel JA, Champagne BJ, Orangio GR, eds. Complexities in Colorectal Surgery: Decision-Making and Management. New York, NY: Springer Science and Business Media; 2014:277–304.

  1. Based on report RE00052291 rev R, Gen II Power Pack EEA™ stapler application software design document. November 2023.
  2. Based on summary K163523, Echelon Circular™* powered stapler 510(k) summary, K163523. April 18, 2017.
  3. Based on internal report RE00124842 rev C, Signia™ circular stapling system (PEEA) summative usability. September 2019.
  4. Based on internal test report RE00174815 rev 1, Software settings for monitoring tissue relaxation. Oct 2021.
  5. Kim JS, Park SH, Kim NS, et al. Compression automation of circular stapler for preventing compression injury on gastrointestinal anastomosis. Int J Med Robot. 2022;18(3):e2374.
  6. Based on internal report R2128-014-0, Anvil removal force. January 2011.
  7. Based on internal memo RE00482367, PEEA/Tri-Staple™ EEA™ anvil equivalence. October 2023.
  8. Based on internal test report RE00421208 rev. 0, PCG-055: Per procedure waste. January 4, 2023.
  9. Lee SW, Gregory D, Cool CL. Clinical and economic burden of colorectal and bariatric anastomotic leaks. Surg Endosc. 2020;34(10):4374–4381.