Technologische Zusammenfassung

FULL SPECTRUM ENDOSCOPY®

FUSE®

Fuse® and Full Spectrum Endoscopy® are registered trademarks of EndoChoice Inc.

Technologie

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Ein Fortschritt in der GI-Bildgebung

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1C Koloskop 330° Sichtfeld

C38s Slim Koloskop 330° Sichtfeld

Technik

Linse

LED LED

Luft/Wasser

Düse

LED

3.8mm Arbeitskanal

Linse

LED LED

Luft/Wasser

Düse

Wasserstrahl

vorwärts

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(170°) Eingeschränkte Sicht mit herkömmlichem Koloskopie

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330° Sichtfeld mit Endoskopiesystem Fuse®

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Sichtfeld vergleich

170

°

330

°

1.5 cm große Polypen können ohne dieses erweiterte Sichtfeld übersehen wurden

Fallstudien

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Fallstudie: Atlanta, GA

• 65-jähriger Patient, Vorsorgekoloskopie

• Sichtbar am rechten Bildschirm, die 1.5cm adenomatöse Polypen

(roter Kreis)

• Der Arzt konnte den Polyp entfernen, der höchstwahrscheinlich mit

einem herkömmlichen Endoskop nicht sichtbar wäre.

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Fallstudie: St. Paul, MN

• 65-jährige Patientin, Nachkontrolle 5-Jahres-Rhythmus

• 6mm große adenomatöse Läsion im linken Bildschirm sichtbar (roter

Kreis)

• Arzt kommentierte: "Ich hätte diesen Polypen ohne die Seitenansicht

durch das Koloskopiesystem „Fuse“ nicht gesehen."

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Fallstudie: Washington, D.C.

• 55-jähriger Patient stellt sich erstmalig zur Koloskopie vor

• Arzt identifiziert eine 4-5mm Läsion zwischen zwei versteckten Falten

(roter Kreis)

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Klinische Daten

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High Miss Rates Highlight A Critical Need

1st Author Year Journal Results Study Design

Rex

1997 Gastroenterology 24% of adenomas missed with colonoscopy (6% of large

adenomas missed)

183 patients;

Tandem study

Pickhardt 2004 Annals of Internal

Medicine

11.8% of large adenomas (>1cm) missed during

colonoscopy (found with CT)

2/3 of missed adenomas were found on the backside of folds

1,223 patients;

CT colonography vs

colonoscopy

Van Rijn 2006

American

Journal of

Gastroenterology

22% of adenomas missed with colonoscopy

(2.1% of large adenomas missed)

465 patients;

Meta-analysis of 6

tandem studies

Heresbach 2008 Endoscopy 21% of adenomas missed with colonoscopy

(11% of advanced adenomas missed)

286 patients;

Tandem study

Rex 2011 Gastrointestinal

Endoscopy

12.0% of large adenomas in ascending colon missed with

standard colonoscopy (found with retroflexed colonoscope)

1,000 patients;

Retroflexed scope for

second look

Siersema

(TERRACE) 2012

World Journal of

Gastroenterology

31% of adenomas missed with standard colonoscopy

11.8% of large adenomas throughout colon missed with

standard colonoscopy

395 patients; Tandem

exams with and without

Third Eye Retroscope®

Gralnek 2014 The Lancet

Oncology 41% of adenomas missed with standard colonoscopy

185 patients, Tandem

study; Traditional

colonoscope vs Full

Spectrum colonoscope

Third Eye Retroscope is a registered trademark

of Avantis Medical Systems, Inc. 14

FUSE® erkennt 69%

mehr präkanzeröse Polypen

Source:

Gralnek IM, Siersema PD, Rex DK, et al. Standard forward-viewing colonoscopy

versus full-spectrum endoscopy: an international, multicentre, randomised,

tandem colonoscopy trial. The Lancet Oncology 2014; 15: 353-60.

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Reduzierte Kosten im Gesundheitswesen

Source:

Hassan C, Gralnek IM. Cost-effectiveness of “full spectrum endoscopy”

colonoscopy for colorectal cancer screening. Digestive and Liver Disease 47

(2015) 390–394.

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Drei überzeugende Themen

aus Tandem -Studien

• FUSE® erfasst 69% mehr präkanzeröse Polypen, und

somit die Verbesserung der Qualität in der Vorsorge.

• FUSE® fand präkanzeröse Polypen bei 6% der

Patienten, die vorher normale Befunde durch Standard-

Koloskopie hatten.

• 9% der Patienten wurden an einen früheren , genaueren

Überwachungsintervall erinnert.

Source:

Gralnek IM, Siersema PD, Rex DK, et al. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre,

randomised, tandem colonoscopy trial. The Lancet Oncology 2014; 15: 353-60. 17

vs.

TFV = Traditional Forward View TER = Third Eye Retroscope Fuse® = Full Spectrum Endoscopy

Miss Rates in Tandem Studies

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Rex et al.

1997 Gastro

N=183

vs. = TFV 24%

= TFV 31%

= TFV

41%

Gralnek et al.

2013 DDW

N=185

Adenoma

Miss Rates

vs.

Tandem Studies

Siersema et al.

2012 WJG

N=349

vs.

TFV = Traditional Forward View TER = Third Eye Retroscope Fuse® = Full Spectrum Endoscopy

Additional Detection in Tandem Studies

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Rex et al.

1997 Gastro

N=183

vs. =

=

=

Gralnek et al.

2013 DDW

N=185

2nd Pass 31%

TER 46%

Fuse®

69%

Additional

Adenomas

Detected by

2nd Procedure

vs.

Tandem Studies

Siersema et al.

2012 WJG

N=349

8 Abstracts Presented with Fuse®

Title Author Presented Conclusion

Fuse Colonoscopy Yields Higher Detection of

Advanced and Multiple Adenomas as Compared to

SFV Colonoscopy: A Post-Hoc Per Patient Analysis

from a Randomized Comparative Trial

Cesare Hassan, Ian

Gralnek

UEGW 2014 As compared to SFV colonoscopy, Fuse colonoscopy appears to be more

effective in identifying patients with multiple polyps and polyps up to

9mm in size, including 6-9mm advanced adenomas. These data appear to

further demonstrate the clinical relevance of the additional adenoma

detection of Fuse as previously shown at a ‘per lesion’ level.

Full Spectrum Endoscopy vs Traditional Forward

Viewing Colonoscopy With and Without Right-Colon

Retroflexion: A Randomized, Bicentric Back-to-Back

Study

Ioniss S.

Papanikolaou, et

al.

UEGW 2014 Our initial results show that Fuse colonoscopy could be an advancement

in colonoscopy by detecting more polyps.

Increased Polyp Detection and Decreased Sedation

Usage in an ASC Setting After Implementing

Panorama Endoscopy Platform

Blair S. Lewis, Ian

Gralnek, Melinda

Lugay

ACG 2014 Fuse technology has similar characteristics to standard endoscopes in

terms of cecal intubation and procedure duration, but requires less

sedation while delivering increased polyp detection.

Forward-viewing colonoscopy versus Full-Spectrum

Endoscopy (FUSE) for dysplasia detection with and

without chromoendoscopy in inflammatory bowel

diseases: a prospective, randomized-order, crossover

tandem surveillance colonoscopy study.

RWL Leong, et al. AGW 2014 Fuse significantly increased dysplasia identification in IBD surveillance.

We confirmed the dysplasia yield of random biopsies in the setting of

IBD is extremely low.

Performance Characteristics of colorectal Full

Spectrum Endoscope (Fuse) – prospective, parallel,

randomized study

Helmet Neumann,

et al.

UEGW 2014 Advancement times of the scope to the cecum and withdrawal times were

faster with Fuse as compared to standard FVE. Satisfaction rates of

patients and endoscopists were similar in both groups while patients

needed more sedation and analgesia in FVE group.

A Prospective Cohort Study Evaluating a Novel

Colonoscopy Platform Featuring Full-Spectrum

Endoscopy

Ian Gralnek, et al. Endoscopy

Vol. 44: April

2013

A colonoscopy platform featuring full-spectrum endoscopy appears

feasible, usable, and safe. These results represent an important advance in

colonoscopy imaging technology and should be further pursued in

comparative human studies.

Comparison of standard-forward viewing mode versus

ultrawide-viewing mode of a novel colonoscopy

platform: a prospective, multicenter study in the

detection of simulated polyps in an in vitro model

Ian Gralnek, et al. Gastrointestin

al Endoscopy

Vol. 77, No.

3: 2013

Ultrawide-view colonoscopy significantly improved simulated polyp

detection in a colon model. Clinical studies in human subjects should be

pursued to further evaluate this new endoscopic technology.

Lighting the Fuse: The First Experience Using the 245-

degree View 1G Gastroscope in the US

Matthew

McKinley, et al.

NYSGE 2013 The Fuse 1G endoscope allows for a greatly expanded view of the upper

GI tract, compared to the 150-degree view from a traditional forward

viewing endoscope.

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