07.12.2009 16:40:00
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Memscap Components Launched with Given Imaging New Colon Pill New Generation of MEMSCAP Device Embedded into the PillCam® COLON 2
Regulatory News:
MEMSCAP (Paris:MEMS)(NYSE Euronext: MEMS), the leading provider of innovative solutions based on MEMS (micro-electro-mechanical systems) technology, today announces it has incorporated its key technology in the PillCam® COLON 2 video capsule manufactured by Given Imaging (Nasdaq: GIVN), the global leader in providing patient-friendly diagnostic solutions for the gastrointestinal community.
PillCam COLON 2, which obtained the CE mark in September, 2009, has been launched in Europe at the Gastro 2009 conference, which took place in London, on November 23. It enables physicians to visualize the colon and includes the following improvements over its first-generation technology: a new imaging angle (172° field-of-view from each imager) offers a near 360° view of the colon; a new RAPID software for image analysis and a new data recording process.
Like other PillCam® capsules in Given Imaging's suite of products, PillCam COLON 2 does not require the use of sedation, intubation or air insufflation during the procedure. The new technologies embedded in the capsule make it an even more functional tool for visualizing the colon. Despite statistical limitations resulting from the size of the trials finalized to date, the new capsule offers a high degree of consistency in the sensitivity and specificity of the data, both of which are high and balanced over the trials already realized.
Given Imaging is initiating additional multicenter clinical trials in the U.S., Europe and Israel and intends to complete these trials over the next few months. Subsequently, it will begin a phased roll out of PillCam COLON 2 in Europe and a few other countries outside of the U.S. in 2010.
MEMSCAP components which are already embedded in other Given Imaging PillCam capsule endoscopes (PillCam ESO 2 and first generation PillCam COLON), are also an integral part of PillCam COLON 2, with a new generation of magnetic switches benefiting from simplified manufacturing processes. This technology enhancement has, among other advantages, enabled substantial gains in terms of manufacturing yields, reliability, manufacturing time, testing time, and particularly has made it possible to eliminate critical suppliers’ dependency through the use of standard processes.
The fit, form and function of the first MEMSCAP magnetic switch qualified for the first generation PillCam COLON have been maintained to ensure a smoother product qualification.
"Given Imaging capsules have revolutionized gastrointestinal tract imaging and offer a patient-friendly alternative. We are pleased to be part of this change and to contribute to this great innovation,” explains Jean Michel Karam, Chief Executive Officer of MEMSCAP.
MEMSCAP medical and biomedical devices, including the magnetic switches embedded in the Given Imaging PillCam video capsules, offer significant advantages to medical device companies worldwide that are looking for miniaturized, more reliable, more efficient, more patient-friendly products. By miniaturising the systems, MEMS is helping to advance minimally invasive surgery and diagnosis to improve medical care and decrease patient suffering.
"MEMSCAP has been for some time now a key partner for our gastrointestinal tract diagnostic solutions”, said Kevin Rubey, Chief Operational Officer of Given Imaging. "Through our partnership, MEMSCAP has showed a unique capability to innovate in the MEMS field. This has once more been evidenced by the development of their new switch generation successfully integrated into our new PillCam COLON 2”.
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal diagnosis 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 better diagnose diseases of the esophagus, small bowel and colon and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. 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 and Singapore. For more information, please visit www.givenimaging.com.
About MEMSCAP
MEMSCAP is the leading provider of innovative micro-electro-mechanical systems (MEMS)-based solutions. MEMSCAP standard and custom products and solutions include components, component designs (IP), manufacturing and related services. MEMSCAP customers include Fortune 500 businesses, major research institutes and universities. The company's shares are traded on the Eurolist of Euronext Paris S.A (ISIN: FR0010298620-MEMS), where MEMSCAP belongs to the Next Economy segment. More information on the company's products and services can be obtained at www.memscap.com.
About PillCam COLON 2
PillCam COLON 2 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. Employing intelligent functionality, PillCam COLON 2 transmits 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. PillCam COLON 2 received a CE Mark in 2009 and will be commercially available in Europe in January 2010.
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