Healthcare Industry News: colonoscopy
News Release - April 17, 2012
Given Imaging Designates Policlinico A. Gemelli, Catholic University in Rome, as First Colon Capsule Endoscopy Center of ExcellenceHospital to Be a Leader in Educational and Clinical Initiatives Related to Colon Capsule Endoscopy
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)- Given Imaging (NASDAQ: GIVN ), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced the designation of the Policlinico Agostino Gemelli in Rome, Italy, as the first colon capsule endoscopy (CCE) Center of Excellence (CoE) in the world. Policlinico A. Gemelli is part of the medical school of the Università Cattolica del Sacro Cuore, the largest private university in Italy. The announcement took place during the EndoLiveRoma 2012, an international endoscopy symposium including live demonstrations and state-of-the-art lectures.
"We are proud that the Policlinico A. Gemelli has been designated as the first colon capsule endoscopy Center of Excellence," said Professor Guido Costamagna, head of the Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, Rome. "Over the last four years, we have developed extensive experience in CCE through our participation in several multicenter clinical trials, as well as through academic endeavors such as developing the recently published European Society for Gastrointestinal Endoscopy (ESGE) guidelines on colon capsule endoscopy. We believe that this makes us optimally positioned to educate other clinicians about this valuable diagnostic tool and serve as a reference destination for patients."
"Given Imaging is delighted to designate Policlinico A. Gemelli, an elite health care organization recognized for its high quality patient care, expert medical professionals and support of scientific innovation, as our first Center of Excellence for colon capsule endoscopy," said Homi Shamir, president and CEO, Given Imaging. "Gemelli continues to be a respected source for physician and nurse education regarding colon capsule endoscopy for its colleagues around the world. Such efforts should help to increase awareness about the role and benefits of colon capsule endoscopy in the visualization of colonic mucosa and expand the use of PillCam® COLON 2 in Europe," he added.
Complementary to other colon examinations, PillCam COLON 2 capsule endoscopy is the only non-invasive exam that provides direct visualization for patients where the risks of other modalities could outweigh the benefits. These patients include those who are at a higher risk for complications due to cardiopulmonary disease or use of blood thinning medications. In addition, this new technology could provide a solution for patients that refuse colonoscopy or those with a previous incomplete colonoscopy.
PillCam capsule endoscopes are ingestible video capsules that enable physicians to visualize distinct portions of the GI tract. Patient-friendly in nature, PillCam endoscopy requires no sedation or insufflation and typically is used on an outpatient basis. With PillCam video capsules for the esophagus, small bowel, and colon, PillCam capsule endoscopy has been clinically validated, as evidenced by more than 1,600 peer-reviewed publications. To date, more than 1.5 million patients worldwide have benefited from PillCam endoscopy.
About PillCam COLON 2
The PillCam COLON 2 video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11.6 mm X 31.5 mm. PillCam COLON 2 is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.
All medical procedures carry some risk. The risks of PillCam capsule endoscopy include capsule retention, aspiration, or skin irritation. PillCam COLON 2 capsule endoscopy presents additional risks, including risks associated with the drug products used to prepare the patient for the procedure, which are currently used for colonoscopy, and to move the capsule through the patient's digestive tract faster. It may also present other risks that are unknown. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
PillCam COLON 2 is not cleared for use in the United States and certain other jurisdictions.
About Agostino Gemelli Teaching Hospital
Agostino Gemelli Teaching Hospital is a large general hospital of 1,850 beds in Rome, Italy. It serves as the teaching hospital for the medical school of the Università Cattolica del Sacro Cuore (the largest privately owned university in Italy, founded in 1921 in Milan), and owes its name to the university founder, the Franciscan friar, physician and psychologist Agostino Gemelli.
About Given Imaging Ltd.
Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® video capsules for the small bowel, esophagus and colon, industry-leading ManoScan™ high-resolution manometry and Bravo® wireless and Digitrapper® pH and impedance products. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam and Hong Kong. For more information, please visit www.givenimaging.com.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) our ability to develop and bring to market new products, (2) our ability to successfully complete any necessary or required clinical studies with our products, (3) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (4) our success in implementing our sales, marketing and manufacturing plans, (5) the level of adoption of our products by medical practitioners, (6) the emergence of other products that may make our products obsolete, (7) lack of an appropriate bowel preparation materials to be used with our PillCam COLON capsule, (8) protection and validity of patents and other intellectual property rights, (9) the impact of currency exchange rates, (10) the effect of competition by other companies, (11) the outcome of significant litigation, (12) our ability to obtain reimbursement for our product from government and commercial payors, (13) quarterly variations in operating results, (14) the possibility of armed conflict or civil or military unrest in Israel, (15) the impact of global economic conditions, (16) our ability to successfully integrate acquired businesses, (17) changes and reforms in applicable healthcare laws and regulations, (18) quality issues and adverse events related to our products, such as capsule retention, aspiration and failure to attach or detach, bleeding or perforation that could require us to recall products and impact our sales and net income, and (19) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2011. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.
Source: Given Imaging
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