given® patency system is an investigational device in the usa

Given® Patency System is an investigational device in the USA

2

RAPID® 3 Software PlatformAdvanced Tools for Diagnostic Proficiency

RAPID® 3 Software PlatformAdvanced Tools for Diagnostic Proficiency

Small Bowel Imaging Enhancements:

Tissue Color Bar simplifies locating anatomical landmarks

QuadView mode improves reading efficiency

Advanced Reporting with My GI Dictionary

QuickView provides pre-scanning overview of case

Esophageal Capabilities:

PillCam ESO captures forward and retrograde images

Individual or simultaneous display of both videos

Displays esophageal transit time

Small Bowel Imaging

Esophageal Imaging

3

RAPID® 3 Software Platform Small Bowel Imaging

RAPID® 3 Software Platform Small Bowel Imaging

4

RAPID® 3 Software Platform Esophageal Imaging

RAPID® 3 Software Platform Esophageal Imaging

5

INDICATIONS

First line diagnostic exam for visualization of small bowel mucosa

Clinical data reviewed 32 independent studies which indicate CE diagnostic yield of 71% vs. 41% diagnostic yield for all other modalities combined1

Established as gold standard for diagnosis of disease of small intestine2

Now cleared in the US for pediatric population from 10-18 years old

1. Internal data at Given Imaging Ltd. Reviewed by the FDA2. Rex, et. Al; WIRELESS CAPSULE ENDOSCOPY DETECTS SMALL BOWEL ULCERS IN

PATIENTS WITH NORMAL RESULTS FROM STATE OF THE ART ENTEROCLYSIS The American Journal of Gastroenterology, Vol. 98, No. 6

PillCam™ Endoscopy of the Small Bowel


6

CONTRAINDICATIONS

In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.

In patients with cardiac pacemakers or other implanted electromedical devices1.

In patients with swallowing disorders.

1 Leighton JA,, et al, SAFETY OF CAPSULE ENDOSCOPY IN PATIENTS WITH PACEMAKERS, Gastrointest Endosc. 2004 Apr;59(4):567-9. Concludes that capsule endoscopy appears to be safe in patients with cardiac pacemakers and does not appear to be associated with any significant adverse cardiac event. Pacemakers do not interfere with capsule imaging.



7

PillCam™ EndoscopyPillCam™ Endoscopy

Easily ingested, painless procedure

Progresses naturally through the GI tract via peristalsis

Ambulatory/office examination

Disposable PillCam™ video capsule

8

1. The PillCam™ Capsule

2. SensorArray™ SB

3. Given® DataRecorder™

PillCam™ SB Exam SetPillCam™ SB Exam Set

2

1

3

9

PillCam™ SBCapsule Components

PillCam™ SBCapsule Components

1. Optical dome2. Lens holder3. Lens4. Illuminating LEDs (light emitting

diodes)5. CMOS (Complementary Metal

Oxide Semiconductor) image6. Battery7. ASIC (Application Specific

Integrated Circuit) transmitter8. Antenna

Dimensions:

Height: 11mm Width: 26mmWeight: 3.7gr

1. Optical dome2. Lens holder3. Lens4. Illuminating LEDs (light emitting

diodes)5. CMOS (Complementary Metal

Oxide Semiconductor) image6. Battery7. ASIC (Application Specific

Integrated Circuit) transmitter8. Antenna

Dimensions:

Height: 11mm Width: 26mmWeight: 3.7gr

10

PillCam™ SB Patient Experience

PillCam™ SB Patient Experience

Liquid diet from lunch the day before

12 hour fast the night before

Capsule ingested in the morning

Liquid diet after 2 hours

Light meal 4 hours after ingestion

Disconnect after 8 hours

11

Images Taken

by the

PillCam™ SB Video Capsule

Images Taken

by the

PillCam™ SB Video Capsule

12

Click on image to view videoClick on image to view video

Normal Villi in theSmall Bowel

Normal Villi in theSmall Bowel

13

Small Bowel Crohn’s DiseaseSmall Bowel Crohn’s Disease


14


Small Bowel Carcinoid TumorSmall Bowel Carcinoid Tumor

15


Malabsorption, Celiac SprueMalabsorption, Celiac Sprue

16

Angiodysplasia Angiodysplasia


17


Colonic diverticulaColonic diverticula

18

PillCam™ SBPillCam™ SB

Patient Outcomes and

Management in OGIB

19

Change in Patient Management& Positive Outcome in OGIB

Change in Patient Management& Positive Outcome in OGIB

CE results led to treatments resolving the bleeding in 86.9% of patients undergoing the procedure while actively bleeding.

(12 – 25 month follow up)

Pennazio M, Santucci R, Rondonotti E, et al. Gastroenterology 2004; 126: 643-653

20


82.6 %Negative predictive value

97.0 %Positive predictive value

95.0 %Specificity

88.9 %Sensitivity

(Analysis of patients with verified final diagnosis, n = 56)

PillCam™ SBHigh Sensitivity & Specificity in OGIB

PillCam™ SBHigh Sensitivity & Specificity in OGIB

21

If done early in the course of the workup,

PillCam™ endoscopy could:

Shorten considerably the time to diagnosis

Lead to definitive treatment in a relevant proportion of patients

Spare a number of alternative investigations with low diagnostic yield

Pennazio et al. 2004Conclusions for OGIB:Pennazio et al. 2004Conclusions for OGIB:


22

PillCam™ SB Endoscopy in

Detecting Crohn’s Disease

PillCam™ SB Endoscopy in

Detecting Crohn’s Disease

23

1. Although 75% of patients with Crohn's disease have small bowel involvement, more than one third have disease isolated to the small bowel.

2. Recent capsule data reveals that there is more extensive small bowel involvement in Crohn's disease than previously recognized. Crohn's disease often involves the proximal small bowel, and may be isolated to the proximal or mid-small bowel in many cases.

Facts about PillCam™ Endoscopy and Crohn’s Disease

Facts about PillCam™ Endoscopy and Crohn’s Disease

24

Capsule endoscopy is more sensitive for small bowel ulcers than the best enteroclysis available.1

Capsule endoscopy is the new gold standard for detection of small bowel Crohn´s disease.1

1 Rex et al. American Journal of Gastroenterology. 2003, 98 (6): 1295-1298

PillCam™ SB Endoscopy The Gold Standard for Small Bowel

Imaging

PillCam™ SB Endoscopy The Gold Standard for Small Bowel

Imaging

25

* P < 0.04

Diagnostic yield (% of patients)

0

10

20

30

40

50

60

70

80

PillCam Capsule SBFT Entero-CT

1 Eliakim et al. European Journal of Gastroenterolgy & Hepatology 2003, 15: 1-5

PillCam™ SB is superior to SBFT/Entero CT in suspected Crohn

´s Disease1

PillCam™ SB is superior to SBFT/Entero CT in suspected Crohn

´s Disease1

26

PillCam™ SBDetecting Crohn´s Disease

PillCam™ SBDetecting Crohn´s Disease

Strictured ulcer

A deep fissure can be seen in the histological examination

Typical granulomas can be seen in the wall of the small intestine

27

PillCam™ SB Crohn´s Disease

PillCam™ SB Crohn´s Disease

Click on image to view videoClick on image to view videoClick on image to view videoClick on image to view video

28

PillCam™ SB

Clinical Acceptance

PillCam™ SB

Clinical Acceptance

29

Clinical AcceptanceClinical Acceptance

In use in over 1,800 sites worldwide (4/04) 1

More than 100,000 ingestions worldwide (4/04) 1

202 Peer Reviewed studies published to date (7/04) 2

1 Data on file www.givenimaging.com2 Medline, 07/04

30

Peer Reviewed Publications (cumulative)

Peer Reviewed Publications (cumulative)

5 1253

122

202

0

50

100

150

200

250

2000 2001 2002 2003 July, 2004

31

5 24 %** 56 % (p<0.05)**89

430 % 55 %21

328 % 59 % (p<0.05)29

256 % 75 % (p=0.04)57

1 28 %* 66 % (p<0.001)*32

Ref.PEPillCam SBN

* lesions = definite source of symptoms** Method only was diagnostic

1 Ell et al. Endoscopy 2002; 34 (9): 685 - 6892 Delvaux et al. Gastrointestinal Endoscopy, April 2002, Vol 55, 5, p: AB88 (Abstract 400)3 Demedts et al. Gastrointestinal Endoscopy, April 2002, Vol 55, 5, p: AB146 (Abstract M20274 Lewis and Swain. Gastrointestinal Endoscopy 2002; 56: 349-3535 Pennazio et al. Endoscopy 2002; 34 (Suppl II) A91

PillCam™ SB: Superior diagnosticyield vs Push-Enteroscopy

PillCam™ SB: Superior diagnosticyield vs Push-Enteroscopy

32

38 lesions22 lesions14

215 % *85 % *20

132 – 37 %70 %20

Ref.X-rayN

* Positive findings

1 Eliakim et al. European Journal of Gastroenterolgy & Hepatology 2003, 15: 1-5 2 Costamagna et al. Gastroenterology 2002; 123: 999-1005

3 Voderholzer et al. Gastrointestinal Endoscopy, April 2002, Vol 55, 5, p: AB139 (Abstract M1999) + Poster, DDW 2002

PillCam™ SB: Superior diagnostic yield versus X-Ray

PillCam™ SB: Superior diagnostic yield versus X-Ray

PillCam™ SB

33

Reference N= Content

Lewis B., Swain P. (1) 20 A bleeding site was found in 11 of 20 patients during capsule endoscopy. No additional diagnoses were made by push enteroscopy. Yield of push enteroscopy was 30%(6/20), yield of CE was 55%(11/20).

Ell C. et al (2) 32 Definite bleeding sites diagnosed by PE in 9/32 patients (28%). Capsule Endoscopy detected definite source in 21/32 patients (66%).

Saurin JC, et al (3) 58 Capsule enteroscopy allowed the diagnosis of a source of bleeding in the intestine in 69.0% of patients with a negative endoscopic work-up. Overall sensitivity of CE was 69%, video push-enteroscopy was 37.9%.

Hartmann D, et al (4) 48 48 patients with suspected disorders of the small intestine. CE showed a bleeding source in 25 cases (76%) and PE showed a positive source in7 cases (21%).

Pennazio M, et al (5) 100 62 patients underwent further examinations that led to independent verification of the diagnosis in 56 patients. CE was positive in 32 of 36 patients with positive final diagnosis (sensitivity 88.9%), and negative in 19 out of 20 patients (specificity 95%). The positive predictive value of CE was 97%, the negative predictive value was 82.6%. The overall accuracy of CE was 91.1%.

Efficacy of PillCam™ Endoscopy in OGIB

Efficacy of PillCam™ Endoscopy in OGIB

34

Efficacy of PillCam™ Endoscopy in Suspected Crohn’s Disease

Efficacy of PillCam™ Endoscopy in Suspected Crohn’s Disease

Reference N= Content

Herrerias JM, Caunedo A, et al (6)

21 A total of 21 pts w/suspicion of Crohn’s disease were studied. Pathological findings were observed in 12/ 21 patients. In the other 9 patients, lesions supporting the diagnosis of Crohn’s disease were seen.

Liangpunsakul S, Rex D, et al. (7)

40 All pts had negative upper, lower endoscopies and SBFT. 3 patients were identified to have multiple small bowel ulcers, despite prior negative small bowel studies. ”Our studies suggest that WCE is better than Enteroclysis in the diagnosis of small bowel ulcers and that WCE is the new gold standard for detection of small bowel Crohn’s.”

Eliakim R, Fischer D, et al. (8)

20 CE established new diagnoses, confirmed existing diagnoses, enlarged the extent of the disease, and ruled out the suspicion of Crohn’s disease in 70% of the patients. SBFT established diagnoses, measured the extent of the disease and ruled out the suspicion of Crohn’s disease in 37% of the patients. CE detected additional lesions that were not detected by other modalities in 47% of cases and ruled out lesions that were detected by other modalities in 16% of cases.

Hara A K, Leighton JA, et al. (9)

52 52 pts underwent CE, 42 had SBFT and 19 had enhanced CT of the abdomen. CE findings were positive in 22 (55%). CE correctly identified 3 pts showing symptoms of inflammatory small bowel disease following the criteria of specialized small bowel imaging protocol.

Fireman Z, Mahajna E. et al. (10)

17 17 pts with suspected but undiagnosed Crohn’s disease comprised this study. The symptoms were consistent with Crohn’s (abdominal pain, iron deficiency anemia, diarrhea, weight loss, elevated ESR). CE identified Crohn’s in 12/17 patients (70.6%).

Mow W, Lo S, et al. (11)

50 WCE findings were diagnostic for Crohn’s disease in 20 patients and suspicious for small bowel Crohn’s disease in 10 patients. Results from diagnostic capsule examinations led to an increase in medical therapy and subsequent improvement of symptoms in 17 of 20 patients.

35

Efficacy of PillCam™ Endoscopy in Tumors and Small Bowel Polyps

Efficacy of PillCam™ Endoscopy in Tumors and Small Bowel Polyps

Reference Content

De Mascarenhas-Saraiva MN, da Silva Araujo Lopes LM.

Series of 130 pts with OGIB evaluated with CE, several tumor types were identified and confirmed with biopsy: Enteroclysis and CT had been normal.

Cobrin GM, Pittman RH, Lewis B

A retrospective analysis of 562 patients undergoing CE with an indication of bleeding or abnormal imaging studies diagnosed tumors in 50 patients (8.9%). This incidence of SB tumors suggests an important role for CE in the algorithm for diagnostic work-up of suspected small bowel lesions.

Keuchel M., Thaler C. Caselitz F., Hagenmiller F.

257 patients were studied with small bowel tumors diagnosed in 16 patients. Indication for CE was obscure bleeding, search of primary hepatic metastasis, polyposis surveillance, diarrhea and nodal lymphoma, weight loss history and carcinoid.

Gay G, Laurent V, et al 129 consecutive patients were screened for suspected intestinal disease or obscure GI bleeding. Patients were scanned with entero-CT scanner with Enteroclysis and CE. 9 patients (7%) were diagnosed with intestinal tumors. All tumors were surgically confirmed. CE detected all of the 9. CT only detected 5, all larger than 8mm. The prevalence of intestinal tumors appears higher in this study than previously reported.

Schulmann K, Hollerbach S. et al

We prospectively examined 33 pts with hereditary polyposis syndromes (21FAP, 10PJS, 2FJP). In 9/10 patients with FAP, 2/2 patients with FJP, and 16/21 patients with FAP we detected small bowel polyps. Reference procedures detected no additional polyps in any of the patents with PJS or FJP.

36

PillCam™ Endoscopy and Pediatrics

PillCam™ Endoscopy and Pediatrics

Reference Content

Seidman EG, Sant'Anna AM, Dirks MH., Gastrointest Endosc Clin N Am. 2004, Jan;14 (1):207-17

Capsule endoscopy is an effective modality for diagnosing pediatric patients with small bowel Crohn’s disease, polyps, and obscure or occult bleeding.

Aabakken L, et al Endoscopy. 2003 Sep;35(9):798.

Illustrates the feasibility of capsule endoscopy even in small children, using an endoscope to insert the capsule. It also shows the low sensitivity of small-bowel follow-through studies in detecting small to moderate-sized tumors in the small bowel.

E G Seidman, et al, J Pediatr Gastroenterol Nutr 2003 Sep;37(3)

Capsule endoscopy is a safe and well tolerated test in pediatric patients over the age of 5 (> 17 kg). Diagnostic accuracy is comparable to adult studies and does not require bowel preparation

William Treem, et al, J Pediatr Gastroenterol Nutr 2003 Sep;37(3)

CE can diagnose unsuspected small bowel Crohn’s disease in patients with persistent iron deficiency anemia and occult blood in the stools. Standard non-specific and specific diagnostic tests indicative of chronic IBD may be entirely unrevealing in these patients.

Bradley A Barth, et al J Pediatr Gastroenterol Nutr 2003 Sep;37(3)

WCE appears to be a safe and more sensitive tool than angiography for detecting small bowel vascular anomalies. Information about location and extent of lesions may be used to plan appropriate therapeutic intervention. The optimal technique and equipment design for WCE in small children requires further study.

37

Efficacy of PillCam™ Endoscopy in Celiac disease

Efficacy of PillCam™ Endoscopy in Celiac disease

Reference Content

Petroniene R, Baker J, et al “The diagnosis if celiac disease may be difficult because only a portion of those with histologic abnormalities exhibit classical symptoms.” The unique advantages of the M2A capsule endoscope, which may facilitate the diagnosis of Celiac disease, are the highly magnified and detailed view of the mucosa and the ability to scan the entire small bowel. CE also allows for approximate estimation of the length of the bowel involved with Celiac disease.

Colin P, Kaukinen K Duodenal biopsy was carried out by Gastroscopy and CE was performed on 13 celiac patients who suffered from GI symptoms despite a strict diet. CE is useful in the follow up, when celiac patients have symptoms and duodenal biopsy shows villous atrophy. By this method it is possible to see the length of Mucosal damage, and also pre-malignant or malignant lesions.

38

Global Reimbursement StatusGlobal Reimbursement Status

39

Global ReimbursementGlobal Reimbursement

Reimbursement for PillCam™ SB is approved in many regions of the world including: Australia, Austria, Denmark, Italy*, Mexico, New Zealand, Portugal, Sweden, and the United States.

* Piemonte

40

Global Reimbursement StatusGlobal Reimbursement Status

(1) Includes suspected Crohn’s disease and may include additional suspected small bowel pathologies

12 1532

48

90

137

3953 62

88

137

161

158

131

98

0

25

50

75

100

125

150

175

200

225

250

Q1/02 Q2/02 Q3/02 Q4/02 Q1/03 Q2/03 Q3/03 Q4/03 Q1/04 Q2/04

Expanded Bleeding

Small Bowel Reimbursement Coverage

3953 62

100

152

193206

221235

Region Covered

Lives (millions)

Fee

U.S. CPT code 91110

Private 139

Medicare 37

Office (global) $928 New York $1,233 Hospital: Technical (APC) $650 Professional $185

Total U.S. 176

Europe

Austria 8 €1,100

Portugal 10 €800

Sweden 8.8 €1,450

Denmark 5.4 €1,459

Switzerland 7.3

Total Europe 40

Australia, NZ 19.3 $1,300

Total 235

41

Reimbursement Developments in US (April 2004)

Reimbursement Developments in US (April 2004)

Assignment of a permanent (level I) CPT code by the AMA (effective January 1, 2004)

BC/BS Tech Assessment finds PillCam™ SB suitable for initial diagnosis of Crohn’s disease

Adopted by BC/BS carriers with 20 million covered lives in total

42

Suspected Crohn’s Disease

Exclusion of small bowel tumors

Gastrointestinal Bleeding

* Guidelines will vary by payer and state Medicare guidelines

Examples of Covered Indications (April 2004)

Examples of Covered Indications (April 2004)

43

Examples of Medicare Global Fees for the Physician office: San Francisco, CA $1,298 Manhattan, NY $1,220 Chicago, IL $1,007 Boston $1,122 Miami, FL $ 976

* Medicare payment varies by geographic index

US Reimbursement (April 2004)US Reimbursement (April 2004)

44

PillCam™ Endoscopy of the Esophagus

PillCam™ Endoscopy of the Esophagus

45

PillCam™ ESOExamination SetPillCam™ ESO

Examination Set

2

13

1. PillCam™ ESO Capsule

2. SensorArray™ ESO

3. Given® DataRecorder™ 2

46

PillCam™ ESO Capsule Components

PillCam™ ESO Capsule Components

Dimensions:

Height: 11mm

Width: 26mm

Weight: 3.7gr

Dimensions:

Height: 11mm

Width: 26mm

Weight: 3.7gr

Dome

Cover

OpticsOptics

Batteries

Dome

PCBSpacer

+Switch

47

Why Screen the Esophagus?Why Screen the Esophagus?

1. Barrett’s Esophagus (BE) is a sequelae of chronic gastroesophageal reflux and is a known pre-malignant lesion.

2. Up to 10% of white males with chronic GERD may harbor BE.

3. It is estimated that patients with BE have approximately a 0.5% per patient year incidence of esophageal adenocarcinoma.

Eliakim et al. Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms. Gastrointest Endosc 2004 Apr;59(5) AB 187 Eliakim et al. Esophageal Capsule Endoscopy (ECE) is Comparable to Traditional Endoscopy for Screening Patients with GERD Symptoms. Gastrointest Endosc 2004 Apr;59(5) AB 187

48

Why Screen the Esophagus?Why Screen the Esophagus?

4. Current accepted practice includes endoscopic screening for BE in those with chronic symptoms.

5. Current society guidelines do recommend screening for this disorder.

6. Patient compliance and economic factors are major barriers to traditional endoscopic screening.

7. The PillCam ESO capsule may provide a promising less-invasive approach to endoscopic screening for disorders of the esophagus.


49

AIM

To compare the performance of the PillCam™ ESO video capsule to standard endoscopy in the detection of esophageal pathologies.

PillCam™ ESO Video Capsule Feasibility Study



50



METHODS

17 eligible patients signed a written informed consent.

Following 6 hours of fast, patients swallowed the twin capsule using a specific supine maneuver.

Patients underwent a standard gastroscopy.

The physician interpreting the RAPID® video was blinded to endoscopy results and vice versa.

Success rates were compared to Gastroscopy as the “gold standard”.


51

Results

All 17 patients swallowed the capsule without any difficulties.

There were no adverse events.

Mean esophageal passage time was 189+280 sec. Compared to 2 sec. in Pillcam SB procedure.

12/17 patients had esophageal pathologies.

Capsule identified all pathologies.

Capsule sensitivity was 100%.




52

PillCam™ ESONormal Z-lineNormal Z-line

PillCam™ ESONormal Z-lineNormal Z-line

53

PillCam™ ESO EsophagitisEsophagitis

54

PillCam™ ESO Suspected Barrett’sSuspected Barrett’sPillCam™ ESO Suspected Barrett’sSuspected Barrett’s

55

PillCam™ ESO PolypsPolyps

PillCam™ ESO PolypsPolyps

56

Traditional Endoscopy detected findings in 12 of 17 pts

PillCam™ ESO detected findings in same 12 of 17 pts, plus 1 additional patient

17512

440-

13112+Capsule

Endoscopy

-+

Traditional Endoscopy

17512

440-

13112+Capsule

Endoscopy

-+

Traditional Endoscopy

Endoscopic Findings

57

1. PillCam™ endoscopy of the esophagus is a convenient, patient friendly and highly sensitive method for visualization of esophageal disorders.

2. PillCam™ endoscopy of the esophagus with bi-directional viewing, may have diagnostic yield advantages over traditional endoscopy.

3. Patients prefer PillCam™ endoscopy of the esophagus over traditional endoscopy.

4. PillCam™ endoscopy of the esophagus may provide an effective method to screen patients for Barrett’s esophagus.

5. Further studies are needed to statistically confirm above results.

ConclusionsConclusions

58

Given® Patency SystemGiven® Patency System

Given® Patency System is an investigational device not cleared for marketing in the USA

59

Given® Patency SystemGiven® Patency System

GivenGiven® ® Patency CapsulePatency Capsule GivenGiven®® Patency Scanner Patency Scanner

26mm long X 11mm diameter(same dimensions asPillCam™ SB)

A dissolvable capsule containing a detectable Radio Frequency Identification (RFID) tag and is propelled through the GI tract by natural peristalsis.

CE Mark Permits marketing in Europe

Given Patency System is an investigational device not cleared for marketing in the USA

60

Advantages of Given® Patency Capsule

Advantages of Given® Patency Capsule

Simple procedureNo prep requiredSafeLow costRadiation-freeMinimally-invasiveClinic-based diagnostic tool Provides effective evaluation of functional patency


61

To assess suspicion of stricturesChronic NSAID use

Crohn’s disease

Radiation enteritis

For strictures not seen radiographically

Post-operative Assessment of anastomosis

Adhesion related disease

Need for Given® PatencyNeed for Given® Patency


62

Before

After

Timer plug

Lactose body w/barium

RFID tag

Exposed window

Parylene coating

12mm

Given® Patency CapsuleGiven® Patency Capsule


63

• Capsule disintegrates after 40 hours• Capsule excreted intact in >80% of

patients in less than 40 hours

Capsule disintegrates after 40 hours

-

Patency proven

Ingestion

Scanning*(24-36 hours)

Patency NOT

proven

*If Given® Patency Scanner is contraindicated, use fluoroscopy

Given® Patency ProcedureGiven® Patency Procedure


64

Given® Patency CapsuleClinical Results

Given® Patency CapsuleClinical Results

Reference Content

Spada C, Spera G, Riccioni ME, et al. M2A Patency Capsule Prior to Video Capsule Endoscopy in Patients with Morphological Small Bowel Strictures.Gastrointest Endosc 2004 Apr; 59(5) AB 1698

11 patients with a diagnosis of Crohn’s disease were prospectively studied. 2 of the 9 patients were excluded from ingesting an imaging capsule. In the other 7 cases the video capsule passed with no adverse events. The video capsule showed the presence of ulcers, cobblestone pattern, mucosal erosions, and a substenotic area.

The patency capsule may indicate functional bowel patency in cases with known morphological intestinal strictures.

Costamagna G, Spada C, Spera G, et al..Evaluation of the Given Patency System in the GI tract: Results of a Multi-Center Study. Gastrointest Endosc 2004 Apr; 59 (5) AB 1697

61 patients ingested the patency capsule, 36 were excreted intact, 27 disintegrated in the GI tract, 1 capsule was retained in a long stricture that was resected at laparotomy. Of the 54 patients who had radiolographically indicated strictures, 31 passed the capsule intact.

The Given patency capsule is a simple, radiation free ingestible diagnostic tool. It indicates functional patency for video capsule passage even in cases where radiography indicates stricture. The excretion of an intact Given patency capsule , within a short time can be used as a predictor of GI patency before the Given video capsule.


65

Given® Patency Capsule ingested 1

month later

Stricture detected

Given® Patency Capsule excreted 7.5 hours following

ingestion

Result I: Patency when Stricture is indicated by Radiology

Result I: Patency when Stricture is indicated by Radiology


66

In 4/4 PillCam™ SB capsules following Given® Patency capsules:

X-ray image with stricture, prior to ingestionsNatural excretion of intact Given® Patency capsulePillCam™ provided additional diagnostic information and video of stricture in small bowel

Result II: When Given® Patency Capsule indicates patency, PillCam™

SB passes naturally

Result II: When Given® Patency Capsule indicates patency, PillCam™

SB passes naturally


67

PillCam™ SB video capsules excreted naturally following intact excretion of Given®

Patency Capsule (17/17 w/SBFT based strictures, all sites)PillCam™ SB provided additional diagnostic information and video of stricture

Given® Patency Capsule

ingested 2 months later

Stricture detected

Given® Patency Capsule excreted

5.5 hours following ingestion

PillCam™ SB video capsule ingested 1 day after Patency

examination

PillCam™ SB video capsule excreted 30 hours after ingestion


Result III: When Given® Patency Capsule indicates patency, PillCam™ SB passes naturally

Result III: When Given® Patency Capsule indicates patency, PillCam™ SB passes naturally

68

ConclusionsConclusions

Given® Patency Capsule is a practical test to assess suspicion of strictures.

May provide direct indication of functional patency, even in cases where radiology indicates physiological stricture.

After Given® Patency Capsule is excreted intact, ingestion of PillCam™ SB video capsule may follow.


given® patency system is an investigational device in the usa

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