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Fig. 2.15 The Endolumik Fluorescence-Guided Gastric Calibration Tube
after turning on NIR lighting system, white light view
D. Hui et al.
Fig. 2.16 The Endolumik Fluorescence-Guided Gastric Calibration Tube
after turning on NIR lighting system, NIR light view

2 Current Fluorescence-Guided Platforms andDevices
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77
calibration tube indicated for use in bariatric, gastric, and esophageal surgery to improve visualization of tube position and to serve
as a sizing and measurement guide, for the application of suction,
gastric decompression/drainage of gastric uids, and irrigation
and leak testing [98]. This device combines the functionality of a
nasogastric or orogastric tube, a calibration tube, and a leak testing system. The device was designed to improve intraoperative
visualization and provide surgeons with additional visual cues to
identify anatomic structures and delineate tissue planes with the
goal of improving the precision of surgical dissection.
The Endolumik Gastric Calibration Tube is lit using NIR spec-
trum LEDs which enable transillumination through esophagogastric tissues. The tube is 80cm long and is available in two different
diameters: 36 and 40 French. It has a rounded tip and small side
holes at the distal end to enable gastric decompression and/or irrigation. The proximal end includes a handle with an integral suction regulator. An additional squeeze bulb with pressure gauge
may be attached to the end of the regulator to perform leak testing.
Pilot studies have been completed using the device to improve
visualization during laparoscopic sleeve gastrectomy and laparoscopic gastric bypass (Figs.2.17, 2.18, and 2.19). The three black
stripes at the distal end of the device enable uorescence-guided
measurement of up to 10cm of length (Fig.2.20).
Fig. 2.17 Use of the Endolumik Fluorescence-Guided Gastric Calibration
Tube during gastric sleeve construction

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Fig. 2.18 Fluorescence-guided gastric sleeve construction during sleeve
gastrectomy operation using the Endolumik calibration tube
D. Hui et al.
Fig. 2.19 Fluorescence-guided gastric pouch construction during gastric
bypass operation using the Endolumik calibration tube
The device was FDA authorized on March 3, 2023, via the
510K pathway [99] and is also the first device to be authorized
through the FDA Safer Technologies Program (STeP), a voluntary program for medical devices that are reasonably
expected to significantly improve the safety of currently available treatments.

2 Current Fluorescence-Guided Platforms andDevices
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Fig. 2.20 Use of the Endolumik Fluorescence-Guided Gastric Calibration
Tube to make uorescence-guided measurements of gastric pouch length during gastric bypass
79
Pearls and Pitfalls
• LED-powered NIR device obviates the need for ICG dye injection.
• Compatible with all NIR surgical camera systems.
• Combines functionality of orogastric tube, calibration tube,
and leak testing system.
• Provides uorescence-guided intraoperative visualization to
enable more precise positioning and surgical dissection.
References
1. Yang H, Kim J, Nam W, Kim HJ, Cha IH, Kim D. Handheld nearinfrared uorescence Imaging device using modied action cameras for
perioperative guidance of microvascular ap surgery. J Clin Med.
2021;10(3):410. https://doi.org/10.3390/jcm10030410.
2. Frangioni JV. New technologies for human cancer imaging. J Clin
Oncol Off J Am Soc Clin Oncol. 2008;26:4012–21. https://doi.
org/10.1200/JCO.2007.14.3065.

80
https://t.me/medicina_free
3. Gioux S, Choi HS, Frangioni. Image-guided surgery using invisible
near-infrared light: fundamentals of clinical translation. Mol Imaging.
2010;9(5):237–55. https://doi.org/10.2310/7290.2010.00034.
4. Goldstein S, Heaton T, Bondoc A, etal. Evolving applications of uorescence guided surgery in pediatric surgical oncology: a practical guide
for surgeons. J Pediatr Surg. 2021;56(2):215–23.
5. Nagaya T, Nakamura Y, Choyke P, etal. Fluorescence-guided surgery.
Front Oncol. 2017;7:314. https://doi.org/10.3389/fonc.2017.00314.
6. DSouza AV, Lin H, Henderson ER, Samkoe KS, Pogue BW.Review of
uorescence guided surgery systems: identication of key performance
capabilities beyond indocyanine green imaging. J Biomed Opt.
2016;21(8):80901.
7. Egloff-Juras C, Bezdetnaya L, Dolivet G, Lassalle HP.NIR uorescenceguided tumor surgery: new strategies for the use of indocyanine green.
Int J Nanomed. 2019;14:7823–38. https://doi.org/10.2147/IJN.S207486.
8. Nagaya T, Nakamura Y, Choyke P, Kobayashi H.Fluorescence guided
surgery. Front Oncol. 2017;7:314.
9. Folli S, Wagnieres G, Pelegrin A.Immunophotodiagnosis of colon carcinomas in patients injected with uoresceinated chimeric antibodies
against carcinoembryonic antigen. Proc Natl Acad Sci U S A.
1992;89(17):7973–7.
10. Namikawa T, Sato T, Hanazaki K.Recent advances in near-infrared
uorescence-guided imaging surgery using indocyanine green. Surg
Today. 2015;45(12):1467–74. https://doi.org/10.1007/s00595- 015-
1158- 7. Epub 2015 Mar 29. PMID: 25820596.
11. Barth CW, Gibbs SL.Fluorescence image-guided surgery- a perspective on contrast agent development. Proc SPIE Int Soc Opt Eng.
2020;11222:112220J. https://doi.org/10.1117/12.2545292.
12. Mondal SB, Gao S, Zhu N, etal. Real-time uorescence image-guided
oncologic surgery. Adv Cancer Res. 2014;124:171–211.
13. Chi C, Du Y, Ye J, etal. Intraoperative imaging-guided cancer surgery.
Teranostics. 2014;4(11):1072–84. https://doi.org/10.7150/thno.9899.
14. Troyan SL, etal. The FLARE intraoperative near-infrared uorescence
imaging system: a rst-in-human clinical trial in breast cancer sentinel
lymph node mapping. Ann Surg Oncol. 2009;16:2943–52.
15. National Center for Biotechnology Information. PubChem compound
summary for CID 16850, Fluorescein. 2021. https://pubchem.ncbi.nlm.
nih.gov/compound/Fluorescein. Accessed 27 Aug 2021.
16. Alander JT, Kaartinen I, Laakso A, Pätilä T, Spillmann T, Tuchin VV,
Venermo M, Välisuo P.A review of indocyanine green uorescent imaging in surgery. Int J Biomed Imaging. 2012;2012:940585. https://doi.
org/10.1155/2012/940585.
17. van Manen L, Handgraaf HJM, Diana M, etal. A practical guide for the
use of indocyanine green and methylene blue in uorescence-guided
abdominal surgery. Journal of Surg Oncol. 2018;118(2):283–300.
https://doi.org/10.1002/jso.25105.
D. Hui et al.

2 Current Fluorescence-Guided Platforms andDevices
https://t.me/medicina_free
18. SPY Elite intraoperative perfusion assessment system- operator’s manual. 2015. Accessed Oct 2021.
19. SPY Elite product brochure. 2018. Accessed Oct 2021.
20. SPY Elite intraoperative perfusion assessment system: K182907. 510K
approval. 2018. Available: https://www.accessdata.fda.gov/cdrh_docs/
pdf18/K182907.pdf. Accessed Oct 2021.
21. Gurtner GC, Jones GE, Neligan PC, etal. Intraoperative laser angiography using the SPY system: review of the literature and recommendations for use. Ann Surg Innov Res. 2013;7(1):1. https://doi.
org/10.1186/1750- 1164- 7- 1.
22. Venturi ML, Mesbahi AN, Copeland-Halperin LR, Suh VY, Yemc
L.SPY Elite’s ability to predict nipple necrosis in nipple-sparing mastectomy and immediate tissue expander reconstruction. Plast Reconstr
Surg Glob Open. 2017;5(5):e1334. https://doi.org/10.1097/
GOX.0000000000001334.
23. Kislevitz ML, Lu KB, Sanniec K, Amirlak B.Unique uses of SPY: highrisk facelift. Plast Reconstr Surg Glob Open. 2019;7(6):e2183. https://
doi.org/10.1097/GOX.0000000000002183. PMID: 31624665; PMCID:
PMC6635201.
24. Newman MI, Jack MC, Samson MC. SPY-Q analysis toolkit values
potentially predict mastectomy ap necrosis. Ann Plast Surg.
2013;70(5):595–8. https://doi.org/10.1097/SAP.0b013e3182650b4e.
PMID: 23542838.
25. Girard N, Delomenie M, etal. Innovative DIEP ap perfusion evaluation tool: qualitative and quantitative analysis of indocyanine greenbased uorescence angiography with the SPY-Q proprietary software.
PLoS One. 2019;14:e0217698.
26. Heniford T. A clinical trial using spy Elite System in planning tissue
advancement aps after ventral hernia repair. ClinicalTrialsgov. 2016.
27. Foppa C, Denoya PI, Tarta C, Bergamaschi R.Indocyanine green uorescent dye during bowel surgery: are the blood supply “guessing days”
over? Tech Coloproctol. 2014;18(8):753–8. https://doi.org/10.1007/
s10151- 014- 1130- 3. Epub 2014 Feb 21. PMID: 24558047.
28. Phillips BT, Fourman MS, Rivara A, Dagum AB, Huston TL, Ganz JC,
Bui DT, Khan SU.Comparing quantitative values of two generations of
laser-assisted indocyanine green dye angiography systems: can we predict necrosis? Eplasty. 2014;14:e44. PMID: 25525483; PMCID:
PMC4258931.
29. Protyniak B, Dinallo AM, Boyan WP Jr, Dressner RM, Arvanitis
ML. Intraoperative indocyanine green uorescence angiography--an
objective evaluation of anastomotic perfusion in colorectal surgery. Am
Surg. 2015;81(6):580–4. https://doi.org/10.1177/000313481508100621.
PMID: 26031270.
30. Hajiran A, Zekan D, etal. Use of SPY Elite uorescence imaging in
creation of a continent urinary diversion. Case Rep Urol.
2019;2019:9069841.
81

82
https://t.me/medicina_free
31. Morozov AO, Alyaev YG, Rapoport LM, Tsarichenko DG, Bezrukov
EA, Butnaru DV, Sirota ES. Near-infrared uorescence with indocyanine green for diagnostics in urology: initial experience. Urologia.
2017;84(3):197–202. https://doi.org/10.5301/uj.5000235.
32. Takahashi M, Ishikawa T, Higashidani K, Katoh H.SPY™: an innovative intra-operative imaging system to evaluate graft patency during offpump coronary artery bypass grafting. Interact Cardiovasc Thorac Surg.
2004;3(33):479–83.
33. Korn JM, Tellez-Diaz A, Bartz-Kurycki M, Gastman B.Indocyanine
green SPY elite-assisted sentinel lymph node biopsy in cutaneous melanoma. Plast Reconstr Surg. 2014;133(4):914–22. https://doi.
org/10.1097/PRS.0000000000000006.
34. Vahabzadeh-Hagh AM, Blackwell KE, Abemayor E, St John
MA.Sentinel lymph node biopsy in cutaneous melanoma of the head
and neck using the indocyanine green SPY Elite system. Am J
Otolaryngol. 2018;39(5):485–8. https://doi.org/10.1016/j.
amjoto.2018.05.006.
35. SPY PHI- operator’s manual. 2020. Accessed Oct 2021.
36. SPY PHI_SPY-QP booklet supplied by Stryker. 2020. Accessed Oct
2021.
37. SPY PHI system with SPY-PHI uorescence assessment software:
K202244. 510K Approval 2020. Available https://www.accessdata.fda.
gov/cdrh_docs/pdf20/K202244.pdf. Accessed Oct 2021.
38. Jakubietz RG, Schmidt K, Bernuth S, Meffert RH, Jakubietz
MG.Evaluation of the intraoperative blood ow of pedicled perforator
aps using indocyanine green-uorescence angiography. Plast Reconstr
Surg Glob Open. 2019;7(8):2462. https://doi.org/10.1097/
GOX.0000000000002462.
39. Nguyen JMV, Hogen L, Laframboise S, Bouchard-Fortier G, Ferguson
SE, Bernardini MQ, May T.The use of indocyanine green uorescence
angiography to assess anastomotic perfusion following bowel resection
in surgery for gynecologic malignancies- a report of 100 consecutive
anastomoses. Gynecol Oncol. 2020;158(2):402–6. https://doi.
org/10.1016/j.ygyno.2020.05.008. Epub 2020 May 15. PMID:
32423604.
40. pde-neoII (C10935)- operator’s manual. 2016. Accessed Oct 2021.
41. Hamamatsu. PDE-neoII brochure. Available: https://www.hamamatsu.
com/resources/pdf/sys/SMES0034E_C10935- 400.pdf. Accessed Oct
2021.
42. Ped-neo: K133719. 510K approval 2014. Available: https://www.
accessdata.fda.gov/cdrh_docs/pdf13/K133719.pdf. Accessed Oct 2021.
43. Shikayama T. Characteristics of the photodynamic eye camera. In:
Kusano M, Kokudo N, Toi M, etal., editors. ICG uorescence imaging
and navigation surgery. Tokyo: Springer; 2016. p.21–7.
44. Tagaya N, Aoyagi H, Nakagawa A, Abe A, Iwasaki Y, Tachibana M,
Kubota K. A novel approach for sentinel lymph node identication
D. Hui et al.

2 Current Fluorescence-Guided Platforms andDevices
https://t.me/medicina_free
using uorescence imaging and image overlay navigation surgery in
patients with breast cancer. World J Surg. 2011;35(1):154–8. https://doi.
org/10.1007/s00268- 010- 0811- y. PMID: 20931198
45. Funai K, Kawase A, Shimizu K, Sekihara K, Yamashita T, Shiiya
N.Fluorescence navigation with indocyanine green for identication of
intersegmental planes using a photodynamic eye camera. J Thorac Dis.
2020;12(9):4817–24. https://doi.org/10.21037/jtd- 20- 1448.
46. Kobayashi K, Kawaguchi Y, Kobayashi Y, Matsumura M, Ishizawa T,
Akamatsu N, Kaneko J, Arita J, Sakamoto Y, Kokudo N, Hasegawa
K.Identication of liver lesions using uorescence imaging: comparison of methods for administering indocyanine green. HPB (Oxford).
2021;23(2):262–9. https://doi.org/10.1016/j.hpb.2020.06.006.
47. Chakedis J, Shirley LA, Terando AM, Skoracki R, Phay JE.Identication
of the thoracic duct using indocyanine green during cervical lymphadenectomy. Ann Surg Oncol. 2018;25(12):3711–7. https://doi.
org/10.1245/s10434- 018- 6690- 4. Epub 2018 Aug 3. PMID: 30076554;
PMCID: PMC6181776.
48. Suzuki Y, Sakuma H, Yamazaki S.Comparison of patency rates of lymphaticovenous anastomosis at different sites for lower extremity lymphedema. J Vasc Surg Venous Lymphat Disord. 2019;7(2):222–7. https://
doi.org/10.1016/j.jvsv.2018.10.022.
49. Fluoptics: Fluobeam LX brochure Supplied by Fluoptics. 2021.
Available https://uoptics.us/wp- content/uploads/2019/10/Fluoptics-
FluobeamLX- EN- web.pdf. Accessed Oct 2021.
50. Fluobeam LX: K190891. 510K approval. 2019. Available. https://www.
accessdata.fda.gov/cdrh_docs/pdf19/K190891.pdf. Accessed Oct 2021.
51. Pruimboom T, van Kuijk SMJ, Qiu SS, van den Bos J, Wieringa FP, van
der Hulst RRWJ, Schols RM.Optimizing indocyanine green uorescence angiography in reconstructive ap surgery: a systematic review
and ex vivo experiments. Surg Innov. 2020;27(1):103–19. https://doi.
org/10.1177/1553350619862097.
52. Louges MA, Bellaiche J, Correia N, Chiriac S, François C.Relevance of
intraoperative indocyanine green injection in breast reconstruction using
DIEP procedure for abdominal scars. Ann Chir Plast Esthet.
2016;61(3):231–4. https://doi.org/10.1016/j.anplas.2016.03.002.
53. Hirche C, Engel H, Kolios L, Cognie J, Hünerbein M, Lehnhardt M,
Kremer T.An experimental study to evaluate the Fluobeam 800 imaging
system for uorescence-guided lymphatic imaging and sentinel node
biopsy. Surg Innov. 2013;20(5):516–23. https://doi.
org/10.1177/1553350612468962. Epub 2012 Dec 27. PMID: 23275469.
54. Demarchi MS, Seeliger B, Lifante J-C, Alesina PF, Triponez
F.Fluorescence image-guided surgery for thyroid cancer: utility for preventing hypoparathyroidism. Cancers. 2021;13(15):3792. https://doi.
org/10.3390/cancers13153792.
55. Kose E, Kahramangil B, Aydin H, Donmez M, Berber E.Heterogeneous
and low-intensity parathyroid autouorescence: patterns suggesting
83

84
https://t.me/medicina_free
hyperfunction at parathyroid exploration. Surgery. 2019;165(2):431–7.
https://doi.org/10.1016/j.surg.2018.08.006.
56. Demarchi MS, Karenovics W, Bédat B, De Vito C, Triponez
F. Autouorescence pattern of parathyroid adenomas. BJS Open.
2021;5(1):zraa047. https://doi.org/10.1093/bjsopen/zraa047.
57. Jafari MD, Wexner SD, Martz JE, McLemore EC, Margolin DA,
Sherwinter DA, Lee SW, Senagore AJ, Phelan MJ, Stamos MJ.Perfusion
assessment in laparoscopic left-sided/anterior resection (PILLAR II): a
multi-institutional study. J Am Coll Surg. 2015;220(1):82–92.e1.
58. David G, Mangano A, Dionigi G, Rausei S, Spampatti S, Cassinotti E,
Fingerhut A.Clinical applications of indocyanine green (ICG) enhanced
uorescence in laparoscopic surgery. Surg Endosc. 2015;29(7):2046–
55. https://doi.org/10.1007/s00464- 014- 3895- x.
59. Pinpoint: endoscopic uorescence imaging system brochure. Supplied
by Novadaq. Available. https://www.mirabellmed.at/resources/media/
pinpoint.pdf. Accessed Oct 2021.
60. Pinpoint endoscopic uorescence imaging system: K182606 510K
approval. 2018. Available. https://www.accessdata.fda.gov/cdrh_docs/
pdf18/K182606.pdf. Accessed Oct 2021.
61. Tsutsui N, Yoshida M, Kitajima M, Suzuki Y.Laparoscopic cholecystectomy using the PINPOINT endoscopic uorescence imaging system
with intraoperative uorescent imaging: a case report. Int J Surg Case
Rep. 2016;21:129–32. https://doi.org/10.1016/j.ijscr.2016.02.036.
62. Arthrex SynergyID system instruction for use manual. 2020. Available.
https://www.manualslib.com/manual/1868210/Arthrex- Synergyid- Ar3200- 0025.html. Accessed Oct 2021.
63. Synergy ID IR1-000394-en-US_A_IR1-000394 CCU and camera head
playsheet Rev2. Supplied by Arthrex. Accessed Oct 2021.
64. Synergy ID FL2-000319-en- US_C_SynergyID_Flyer_210x297mm_
web. Supplied by Arthrex. Accessed Oct 2021.
65. Synergy ID IR1-000390_SynergyID augmented reality Playsheet rev 2.
Supplied by Arthrex Accessed Oct 2021.
66. Arthrex SynergyID endoscopic imaging system: K202582. 510K
approval. 2021. Available https://www.accessdata.fda.gov/cdrh_docs/
pdf20/K202582.pdf. Accessed Oct 2021.
67. Visera Elite II VEII_Borchure_A4_297x210mm_EN_v20 publically
available on Olympus. Accessed Oct 2021.
68. Visera Elite II Xenon Light Source. K200542. 510K approval. 2020.
Available at https://www.accessdata.fda.gov/cdrh_docs/pdf20/
K200542.pdf. Accessed Oct 2021.
69. 1688 4K camera system with advanced imaging modality user manual.
Available at https://5.imimg.com/data5/SELLER/Doc/2021/5/AY/MU/
PK/24888028/stryker- 1688- endoscopic- camera.pdf. Accessed Oct
2021.
70. 1688 AIM - 1588 to 1688 AIM 4K platform justication packet.
Supplied by Stryker. Accessed Oct 2021.
D. Hui et al.

2 Current Fluorescence-Guided Platforms andDevices
https://t.me/medicina_free
71. Nitta T, Tanaka K, Kataoka J, etal. Novel technique with the IRIS U kit
to prevent urethral injury in patients undergoing transanal total mesorectal excision. Ann Med Surg (Lond). 2019;46:1–3. https://doi.
org/10.1016/j.amsu.2019.08.002.
72. Storz Image I user manual PDF.Accessed Oct 2021.
73. Image 1S Rubina Brochure. Available. https://www.karlstorz.com/cps/
rde/xbcr/karlstorz_assets/ASSETS/3623282.pdf. Accessed Oct 2021.
74. Rubina: K201399. 510K approval. 2020. Available at https://www.
accessdata.fda.gov/cdrh_docs/pdf20/K201399.pdf. Accessed Oct 2021.
75. Image 1S Rubina application in colorectal surgery- supplied by Karl
Storz. Available at https://www.karlstorz.com/cps/rde/xbcr/karlstorz_
assets/ASSETS/3646673.pdf. Accessed Oct 2021.
76. Image 1S Rubina application in cholecystectomy - supplied by Karl
Storz. Available at https://www.karlstorz.com/cps/rde/xbcr/karlstorz_
assets/ASSETS/3646675.pdf. Accessed Oct 2021.
77. VS3-Iridium- guide. Available at https://www.medtronic.com/content/
dam/covidien/library/us/en/product/visualisation- systems/elevision- irplatform- ibrochure.pdf. Accessed Oct 2021.
78. Elevision IR brochure. Available at http://www.medtronic.me/content/
dam/covidien/library/us/en/product/visualisation- systems/elevision- irplatform- mis- brochure.pdf. Accessed Oct 2021.
79. VS3-IR. 510K approval. 2019. Available at https://www.accessdata.fda.
gov/cdrh_docs/pdf19/K191851.pdf. Accessed Oct 2021.
80. Hoveling R. Quest medical imaging. Brochure available at https://
dutchphotonicsevent.nl/wp- content/uploads/2019/09/RichelleHoveling- Making- the- invisible- visible.pdf. Accessed Oct 2021.
81. Artemis handheld imaging system. K191851. 510K approval. 2015.
Available https://www.accessdata.fda.gov/cdrh_docs/pdf14/K143474.
pdf. Accessed Oct 2021.
82. van Driel PB, van de Giessen M, Boonstra MC, etal. Characterization
and evaluation of the artemis camera for uorescence-guided cancer
surgery. Mol Imaging Biol. 2015;17(3):413–23. https://doi.org/10.1007/
s11307- 014- 0799- z.
83. Wu G.Fluorescence image-guided robotic surgery. In: Liao J, Su LM,
editors. Advances in image-guided urologic surgery. NewYork, NY:
Springer; 2015. https://doi.org/10.1007/978- 1- 4939- 1450- 0_5.
84. DaVinci Xi system user manual- supplied by intuitive. Accessed 2021.
85. DaVinci Firey imaging system. K141077. 510K approval. 2014.
Available at https://www.accessdata.fda.gov/cdrh_docs/pdf14/
K141077.pdf. Accessed 2021.
86. Intuitive; uorescence imaging for da Vinci X and da Vinci Xi surgical
systems provided by intuitive. 2021.
87. Kim J, Ferguson J, Shrand J, Pitt E, etal. Integrating Firey uorescence into image guidance for the da Vinci Robot. SPIE Digital Library;
2021.
85
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