# Gastrointestinal tract through a dissolvable capsule



## SpAsMaN* (May 11, 2002)

http://www.givenimaging.com/Cultures/en-US...PR_20060512.htmPress Releases (Back to Press Release Headlines) Given Imaging's Agileâ„¢ Patency System Receives US Marketing Clearance YOQNEAM, Israel, May 12, 2006 -- Given Imaging Ltd. (NASDAQ: GIVN) today announced that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the Agile Patency System which enables physicians to determine the presence of obstructions or strictures in the gastrointestinal tract through a dissolvable capsule. The Agile Patency Capsule will give physicians confidence that a PillCamâ„¢ video capsule will pass freely in a patient with known or suspected strictures. Shoshana Friedman, Senior Vice President, Regulatory & Clinical Affairs of Given Imaging said, "This FDA clearance allows us to expand our market beyond the current patient population to include patients with suspected strictures that are currently contra-indicated. This is especially good news for symptomatic patients with known Crohn's disease, and, in particular, can make a significant difference for the pediatric patient. Given remains committed to providing physicians with patient-friendly tools that enable them to better diagnose GI disorders and improve the quality of life of their patients." Given has been marketing a similar Patency System in Europe since November 2003. The Agile Patency System has also been cleared for marketing in Australia.


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## SpAsMaN* (May 11, 2002)

Strictures are NOT always a surgical case with the conventional pill camera:You should check the research abstract here:http://www.givenimaging.com/given/ftp/ICCE2005_Abstracts.pdf


> quote:CAPSULE RETENTION IN SMALL BOWEL STRICTURES: A RETROSPECTIVE STUDYS. Fernandez-Diez, M. Asteinza, F. Gonzalez, W. Baki, J.M. Loscos, J.A. Ramirez-ArmengolEndoscopy Deparment, Hospital Clinico San Carlos, Madrid, SpainBackground: Small bowel strictures with capsule retention have been considered a 'therapeutic complication' as itmight indicate the presence of a lesion. Objective: To determine whether CE retention represents a surgicalcomplication, preventable based on clinical and laboratory findings plus imaging techniques. Methods: Aretrospective review was performed using our database of CE cases. Indications for CE were as follows: 12 caseswith GI bleeding of unknown origin; 4 cases with suspected Crohn's disease; 3 patients complaining of abdominalpain but no symptoms of obstruction; one case of anemia and presumed Meckel's. Conventional radiographic andendoscopic studies were performed to rule out a stricture or tumor, and all of them were normal. Results: In 20cases capsule was retained due to unsuspected stricture. 13 female/7 male. Mean age 48.2 years (22-85). CEidentified strictures in jejunum or ileum (5). In 4 cases capsule was retained but passed through the lesion,increasing the small bowel transit time. In the remaining cases, capsules were not able to get through the stricture.Acute small bowel obstruction did not occur in any patient. Capsules were excreted between 2 days and 4 weekspost-examination, not requiring surgery. Etiology of the obstructing lesions: 3 apparent NSAIDs-induced stricture,10 cases of Crohn's disease (one had known Crohn's and patency capsule was administrated prior to M2A, anotherpatient suffered from ulcerative colitis); One case revealed a polypoid lesion; 2 cases had retention in surgicalanastomosis of a previous jejunal resection because of angiodysplasia; etiology of the remaining cases was unclearso far. Conclusion: Small bowel strictures and its complication are not always preventable despite comprehensivediagnostic work-up. Retention of the capsule may indicate the presence of a lesion not necessarily requiringsurgery. Waiting time to excrete capsule could be up to 6-8 weeks.


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## SpAsMaN* (May 11, 2002)

Rigth lateral positionning expell better the pill from the stomack:


> quote:THE EFFECT OF PATIENT POSITIONING ON COMPLETE SMALL BOWEL EXAMINATION RATESWITH WIRELESS CAPSULE ENDOSCOPY: AN INTERM ANALYSISC.J. O'Loughlin, N SlindeDivision of Gastroenterology, Medical College of Wisconsin, Milwaukee, WI, USAWCE allows direct visualization of the Small Intestinal (SI) mucosa. However, delay in transit of the CapsuleEndoscope (CE) from the stomach to the duodenum and a limitation in the CE's battery life contribute toincomplete SI examinations. We hypothesize that right lateral positioning of patients expedites the passage of theCE through the pylorus allowing for more complete SI evaluations and increased diagnostic yield. Aim: Toevaluate (1) the effect on the gastric emptying time (GET), (2) the proportion of complete SI studies and (3) thediagnostic yield of WCE in patients placed in the right lateral position (RLP) compared with the standing/sittingposition post CE ingestion (SSP). Methods: 67 consecutive studies in patients undergoing WCE for investigation ofObscure Gastrointestinal Bleeding (OGIB) from 9/03 - 9/04 were analyzed retrospectively. 9 patients wereexcluded, 5 (endoscopic placement of the CE), 3 (h/o gastric surgery), 1 (gastroparesis). Patients remained in theRLP or in the sitting/standing position for 30 mins post CE ingestion. Major findings were defined as ulcers,AVMs, strictures, and active bleeding. Results: The 58 remaining studies (31 men, 27 women, age range 16-80),included 35 patients from the RLP group and 23 from the SSP group. The mean GET (time from the first image ofthe stomach to the first image of the duodenum) in the RLP grp was 27 mins compared with 52 mins in the SSP grp(P < 0.05). The mean small intestinal emptying time was similar in groups, RLP 207 mins and SSP 203 mins.Major findings were reported in 57% of the RLP grp and 43% of the SSP grp (NS). Stricturing of the SI precludingpassage of the CE occurred in 4 cases and 1 case in the RLP and SSP grps respectively. 2 battery failures occurredin the SSP. Otherwise incomplete examinations of the SI were reported in 6% of the RLP grp and 9% of the SPPgrp (NS). Conclusion: Positioning patients to the RLP facilitated passage of the CE into the SI without need forpromotility agents and should be considered an initial option in the clinical setting. Although there was a numericaltrend toward increased diagnostic yield and complete examinations of the SI in the RLP grp these were notsignificant.


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