Healthcare Industry News: endoscopy
News Release - October 18, 2010
Given Imaging Launches New Products to Expand Access to PillCam(R) Capsule Endoscopy at ACG Annual Meeting 2010Latest-Version Reading Software Offers Physicians Improved Workflow and Technological Compatibility; New 12-Hour Small Bowel Capsule and PillCam Delivery Device Provide Targeted Tools for Specialized Patient Populations
SAN ANTONIO, TX--(Healthcare Sales & Marketing Network) - Given Imaging Ltd. (NASDAQ:GIVN ), the world leader in specialty GI products and pioneer of capsule endoscopy, today unveiled two new products: PillCam Express, a video capsule delivery device for patients who are unable to ingest the capsule or who have slow gastric emptying times, and PillCam SB 2-EX, a small bowel capsule which extends capsule operating time to a minimum of 12 hours for patients who are confirmed or believed to have slow motility. The company also launched an updated version of its proprietary software program, RAPID® 6.3, designed to work with all versions of Windows 7, improve the user experience and reduce potential for data errors.
PillCam Express, PillCam SB 2-EX and RAPID 6.3 can be seen, along with Given Imaging's entire line of products, at the Company's booth #715 at the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course taking place in San Antonio, Texas, from October 15 through October 20, 2010.
"Given Imaging's commitment to innovation is evidenced by our continuous introduction of new products and upgrades aimed at meeting the real-life needs of patients and the health care providers who care for them," said Homi Shamir, President and CEO, Given Imaging. "PillCam Express, PillCam SB 2-EX and RAPID 6.3 demonstrate that commitment to innovation, to patients and to serving the GI community."
The PillCam Express video capsule delivery device enables capsule placement in patients who are unable to ingest the capsule or who have slow gastric emptying times and was designed to work specifically with the PillCam SB 2 family of video capsules. PillCam Express includes the following features:
- Clear design enables visualization of capsule deployment through the endoscope
- Single-use, quick-locking mechanism that safely secures the capsule holder to the catheter
- Proprietary balloon deployment mechanism specifically designed to work with the current generation of PillCam SB 2 video capsules, ensuring that the capsule will not be scratched or damaged
- Smooth catheter design to ensure no damage to the working channel of the endoscope
PillCam SB 2-EX offers a 12-hour extended procedure for patients with known or suspected slow motility. Physicians may consider using PillCam SB 2-EX for hospital inpatients or other patients who are immobile, taking pain medication or have undergone recent sedation. PillCam SB 2-EX:
- Collects data for a minimum of 12 hours and can be used with RAPID Real-Time handheld viewer to confirm capsule progress.
- Is FDA-cleared for use in children two years and older.
- Can be used independently or in conjunction with the PillCam Express placement device.
The latest version of the RAPID® Software Suite, which includes RAPID v6.3, RAPID® Access and RAPID® Reader, incorporates the following new features:
- Compatibility with Windows 7, Windows Vista, Windows XP in 32- and 64-bit versions, with support for widescreen and different screen resolutions
- Spell-check capabilities in eight languages, including English.
- Smart Check-in with pull-down menu options and built-in safety measures to prevent incompatible check-in data combinations
- Enhanced Study Manager, which enables multi-study operations and allows users to define portions of the data display
Since 2001, Given Imaging has advanced gastrointestinal visualization by developing innovative, patient-friendly tools based on its PillCam® Platform. PillCam® capsule endoscopy provides physicians with natural images of the small intestine via PillCam® SB, the esophagus through PillCam® ESO and the colon with PillCam® COLON [PillCam COLON is not cleared for use in the USA]. The PillCam® capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile™ patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). Given Imaging's products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to visualize diseases of the esophagus, small bowel and colon. All Given Imaging products allow patients to maintain normal activities. 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. Sierra Scientific is now a wholly-owned subsidiary of Given Imaging. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Singapore 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 and (18) 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, 2009. 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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