Colon Capsule Endoscopy Preferred in 49% of Patients Who Previously Declined Physician Recommended Conventional Colonoscopy
HONG KONG--(Marketwire - October 9, 2012) - Given Imaging Ltd, a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the results published in the September edition of the Journal of Clinical Gastroenterology showing that the availability of colon capsule endoscopy devices like the PillCam® COLON 2 could potentially increase adherence to physician recommended colon examinations among patients who decline conventional colonoscopy.
"Colorectal cancer affects hundreds of thousands of lives each year and adherence to screening plays a critical role in early detection and diagnosis," noted Douglas K. Rex, M.D., study author and Professor of Medicine at Indiana University School of Medicine and Director of Endoscopy at Indiana University Hospital. "This study is significant because it suggests that if colon capsule endoscopy was made available to patients, it could potentially result in an overall increase in adherence among patients who had previously declined colonoscopy," he added.
"In Hong Kong, where colorectal cancer is the second-leading cancer killer with more than 4,300 new cases and 1,700 deaths per year, increased adherence to colorectal cancer screening is critical. In light of these alarming statistics, the Institute of Digestive Disease at The Chinese University of Hong Kong, as a recognized Center of Excellence in Capsule Endoscopy, is proud to offer PillCam® COLON 2 as a safe, accurate, non-invasive and therefore more acceptable test option for our patients," said Professor Joseph Jao-Yiu Sung, Founding Director of the Institute.
The new data is based on a survey conducted among individuals who had been recommended colonoscopy screening within the past three years by their primary care physician and aimed to determine the potential value of PillCam COLON capsule endoscopy for screening adherence. The study results demonstrate that 24% of individuals with a prior colonoscopy chose colon capsule endoscopy. A total of 49% of subjects who previously declined colonoscopy chose colon capsule endoscopy, showing that patients who declined colonoscopy previously were statistically more likely to prefer a capsule examination over conventional colonoscopy as a potential screening test.
A total of 308 geographically diverse subjects in the U.S., aged 50-80 years of age, participated in the internet-based survey to determine the potential impact of colon capsule endoscopy on adherence rates for colorectal cancer screening. The highest ranked reasons for declining conventional colonoscopy were: bowel preparation (15%), invasiveness (15%), cost (14%), lack of sufficient benefit to health (13%), need for sedation (9%), lack of time for the procedure (9%), convenience (6%), and need for a ride home (5%). More than 50% of patients reported bowel preparation and invasiveness among their top three reasons for declining conventional colonoscopy. Additionally, patients that had declined colonoscopy viewed certain elements of conventional colonoscopy as more negative than did patients who had agreed to undergo colonoscopy previously.
For the last part of the study, a profile of PillCam® COLON 2 was shared summarizing the features of colon capsule endoscopy technology and how the test is performed. The overview also addressed the preparation process (the need for liquids and bowel preparation the day and evening before the morning of the procedure), noting that no sedation was required. After viewing the profile, 43% of individuals with a prior colonoscopy chose colon capsule endoscopy, 51% chose conventional colonoscopy, 4% chose FOBT and 3% preferred no test. Among those patients who had declined a traditional colonoscopy previously, 69% chose capsule colonoscopy, 22% chose conventional colonoscopy, 3% chose FOBT and 6% chose no test.
Additional test characteristics were presented to determine the potential impact on acceptance, leading to the final results of 49% for those that declined colonoscopy and 24% for those with a prior colonoscopy. Lack of need for sedation and minimal invasiveness were considered the most attractive features of colon capsule endoscopy. The ability to screen and treat in the same procedure and accuracy were considered the most important advantages of conventional colonoscopy.
About PillCam COLON 2
The PillCam® COLON 2 capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11 mm X 31 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.
The risks of PillCam capsule endoscopy include capsule retention, aspiration, or skin irritation. PillCam COLON 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, including allergies or other known contraindications to any preparation agents or medications used for the PillCam COLON regimen, according to laxative medication labeling and per physician discretion. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. For more information, please visit pillcamcolon.com.
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(tm) 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, Hong Kong, and Brazil. For more information, please visit www.givenimaging.com.
Forward Looking Statements
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 payers, (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.
For further information contact:
Chantal Beaudry
Lazar Partners Ltd.
cbeaudry@lazarpartners.com
212-867-1762
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