Given Imaging

Given Imaging (Hebrew: גיוון אימג'ינג) is an Israeli medical technology company that manufactures and markets diagnostic products for the visualization and detection of disorders of the gastrointestinal tract. Until March 2014, it was dual-listed on both the NASDAQ and the Tel Aviv Stock Exchange, where it was a component of the TA-100 Index and the TA BlueTech Index. In March 2014 it was acquired by Covidien and became a private company. In 2015 Covidien was purchased by Medtronic.

Given Imaging Ltd.
TypePrivate
Industrymedical technology
Founded1998 (1998)
HeadquartersYokneam Illit, Israel
Key people
Homi Shamir, CEO
Productscapsule endoscopy
Revenue US$ 177.95 million (2011)
US$ 12.98 million (2011)
US$ 11.97 million (2011)
OwnerMedtronic
Number of employees
800
Websitewww.givenimaging.com
Endoscopic capsule
Endoscopic capsule end-on, showing six LEDs and camera lens.

Given Imaging pioneered the capsule endoscopy technology and has also developed capsule-based pH monitoring.[1] Through Sierra Scientific Instruments, a subsidiary, Given Imaging also provides an array of diagnostic modalities including high-resolution manometry and ambulatory reflux monitoring. Given Imaging's technology is currently marketed in over 60 countries.

History

Given Imaging was founded in 1998 by Dr. Gabi Iddan and Dr. Gavriel Meron, initial funding for the company was provided by Elron Electronic Industries, Israel's leading technology holding company, in cooperation with Rafael Advanced Defense Systems. Today Elron still holds 28% Given Imaging's shares.[2] The idea for the solution was developed by Dr. Iddan, while working in the missile division of Rafael, where he envisioned that missile technology could be miniaturized to create a medical product.[3]

The company's first capsule endoscopy products was named M2A capsule and received it CE marking in May 2001 and in August 2001 was cleared by the US Food and Drug Administration (FDA) for visualization of abnormalities of the small intestine[4] The capsule uses a radio developed for Given by Zarlink Semiconductor's medical team in San Diego and Jarfalla, Sweden.

In October 2001, Given Imaging had an Initial public offering on NASDAQ under ticker GIVN.)[5] In September 2004, M2A capsule re-branded PillCam SB(R).

In March 2004, Given Imaging became a member of the Tel Aviv Stock Exchange[6]

In November 2004, US FDA clears PillCam(R) ESO for the esophagus

In May 2006, US FDA clears Agile Patency System[7]

In October 2006, PillCam COLON was cleared for marketing in the European Union (CE Mark)[8]

In May 2007, Second-generation PillCam SB 2 received U.S. marketing clearance and in June 2007, Second-generation PillCam ESO 2 received U.S. marketing clearance

In December 2008, Given Imaging acquired Bravo pH Monitoring System(R)

In May 2009, 1 millionth PillCam capsule was sold[9]

In September 2009, PillCam COLON 2 receives CE Mark[10]

In April 2010, Given Imaging acquired Sierra Scientific Instruments

In July 2012, Given Imaging's capsule endoscopy featured in a live broadcast on the BBC, when the reporter Michael Mosley spent the day as an exhibit at the Science Museum in London, after swallowing a PillCam which transmitted live pictures to a public screen.[11]

In February 2014, 100% of Given Imaging's shares were purchased by Covidien, making it a Private Company fully owned by Covidien. As a result, its shares are no longer traded neither in NASDAQ nor in TASE[12]

In 2015 Covidien was purchased by Medtronic

Products

PillCam SB

PillCam SB is a patient-friendly tool for visualization of the entire small bowel and detection of small bowel abnormalities. No sedation is needed, however bowel prep is needed. A liquid bowel prep is consumed before the procedure emptying the bowel completely, this allows clear photos to be taken.[13]

PillCam ESO

PillCam ESO provides a clinically proven, time-efficient and patient-friendly[14] method for visualization of the esophagus.[15]

PillCam COLON 2

PillCam COLON 2 is complementary to traditional colonoscopy and is used for patients who have received incomplete colonoscopy, are contraindicated for colonoscopy or are unwilling to undergo traditional colonoscopy.

PillCam CROHN'S

The PillCam CROHN’S system offers a solution by obtaining direct visualization of the entire small bowel and colonic mucosa with a noninvasive procedure.

PillCam Express

In May 2010, Given Imaging released a new manually guided GI scope based on PillCam swallowable devices. In cases where patient anatomy does not allow for natural passage of large tablets the size of traditional PillCams, the PillCam Express can be delivered through the stomach and into the small intestine with help of an endoscope and a proprietary balloon deployment mechanism.[16]

Bravo pH Monitoring System

The Bravo pH Monitoring System is a catheter-free ambulatory pH test.[17] Ambulatory pH testing is considered the gold standard for pH measurement and monitoring of gastric reflux, helping clinicians manage gastroesophageal reflux disease (GERD). Featuring data collection for up to 96 hours, Bravo allows patients to maintain their regular diets and activities, accurately reflecting normal physiologic conditions.

Sierra Scientific Instruments

In April 2010, Given Imaging acquired Sierra Scientific Instruments, a leading provider of specialty GI diagnostic solutions and pioneer of high-resolution manometry for assessing gastrointestinal motility. The ManoScan 360 High-Resolution Manometry System has advanced diagnostic technology that captures all relevant esophageal motor function from the pharynx to the stomach with a single placement of the catheter. An average esophageal study can be completed in 10 minutes or less. The ManoScan 360 can be upgraded to incorporate an array of diagnostic modalities including manometry with impedance as well as anorectal and 3D HRM Manometry. Sierra Scientific also provides the AccuTrac pH and pH-Impedance Monitoring System, pH and pH-Z disposable catheters and ManoShield disposable catheter sheaths for both esophageal and anorectal catheters. Additionally, Sierra Scientific offers the Polygraf ID stationary gastrointestinal function testing platform and the Digitrapper(R) ambulatory pH monitoring system.[18]

Headquarters and plants
Given Imaging headquarters in Yokneam

The company's corporate headquarters, research and development laboratories, and manufacturing facilities are located in Yokneam, Israel.[19] It maintains offices in Duluth, Georgia and Heerlen, Netherlands. Additional sales and marketing offices are located in France, Japan, Australia, and Singapore. The company also has a plant in Ireland.

Given Imaging's wholly owned subsidiary, Sierra Scientific Instruments, is located in Los Angeles, California, with manufacturing operations in Vietnam.

See also

References
  1. "Invest in Israel: Given Imaging". Archived from the original on 2011-07-21. Retrieved 2010-10-14.
  2. Elron Announces That Given Imaging, Held Directly and Indirectly 15% by Elron, Announced Initial Public Offering. Business Wire, October 4, 2001
  3. "RDC – Rafael Development Corporation Ltd - Given Imaging Copnay History". Archived from the original on 2014-08-02. Retrieved 2019-12-29.
  4. Athena: Clinical Policy Bulletin: Capsule Endoscopy
  5. Given Imaging: First IPO since August IPO Report - MarketWatch - 4 Oct 2001
  6. Given Imaging Registration Document March 22, 2004
  7. Given Imaging's Agile(TM) Patency System Receives US Marketing Clearance, Medical News Today, 17 May 2006
  8. Pillcam(R) COLON May Be A Cost-Effective Strategy For Preventing Colo-Rectal Cancer, Study, Medical News Today 11 Apr 2008
  9. Given Imaging Announces One Millionth PillCam Video Capsule, Marketwire May 20, 2009
  10. Given Imaging'c PillCam COLON 2 video capsule and system receives the CE mark for sale in Europe, The Medical News, 14. September
  11. The second brain in our stomachs, 12 July 2012, Michael Mosley, BBC
  12. Announcement Regarding Completion of Merging with Covidien
  13. Given Imaging to Launch Advanced PillCam(TM) SB Video Capsule for the small bowel
  14. De Bona M, Bellumat A, Cian E, Valiante F, Moschini A, De Boni M. Capsule endoscopy findings in patients with suspected Crohn’s disease and biochemical markers of inflammation. Dig Liver Dis. 2006;38;28:331-335. 14. Valle J, Alca´ntara M, Pe´rez-Grueso JM, Navajas J, Mun˜oz-Rosas C, Legaz ML, Rafael Cuena, Carrobles JM. Clinical features of patients with negative results from traditional diagnostic work-up and Crohn’s disease findings from capsule endoscopy. J Clin Gastroenterol. 2006 Sept;40(8):692-696.
  15. The accuracy of PillCam ESO capsule endoscopy versus conventional upper endoscopy for the diagnosis of esophageal varices: a prospective three-center pilot study. Endoscopy. 2006;38(1):1-5. 20. Eliakim R, Fireman Z, Gralnek IM, Yassin K, Waterman M, Kopelman Y, Lachter J, Koslowsky B, Adler SN. Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study. Endoscopy. 2006 Oct;38(10):963-70.
  16. MedGadget: PillCam Express
  17. "Endoscopy Unit - Bravo PH Monitoring System - Wooster Community Hospital". Archived from the original on 2010-10-25. Retrieved 2010-10-16.
  18. Given Imaging Acquires Sierra Scientific Instruments | MDDI Magazine
  19. GIVEN IMAGING LTD | Israel Company Search
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