PARIS, January 14, 2015 /PRNewswire/ --
- Editorial accompanies publication of CONTACT 1 Study results showing that needle-based confocal laser endomicroscopy with Cellvizio able to confirm benign serous cystadenomas with 100% specificity.
- Mauna Kea Technologies, inventor of Cellvizio, on track to complete enrollment in 200-patient CONTACT 2 Study on use of nCLE in diagnosis of pancreatic cysts.
Mauna Kea Technologies (Euronext: MKEA, FR0010609263), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced that the peer-reviewed journal Endoscopy has published an editorial in the print edition highlighting the advantages of needle-based confocal laser endomicroscopy (nCLE) for characterization of pancreatic cysts. The editorial accompanies publication of results of the CONTACT 1 prospective multicenter study showing that optical biopsy procedures performed with Cellvizio were able to confirm the nature of benign pancreatic cysts in 100% of patients where a superficial vascular network was observed.
"Using Cellvizio, doctors were able to confirm that pancreatic cysts are benign based on observation of a superficial vascular network that is visible for the first time ever by using our Cellvizio nCLE technology," said Sacha Loiseau, CEO and founder of Mauna Kea Technologies, adding, "We are very pleased that the journal Endoscopy chose to single out our landmark technology with an editorial. The use of Cellvizio has the potential to significantly improve the ability to confirm that cysts are benign and help thousands of patients avoid unnecessary and often risky surgical interventions."
The editorial, authored by Marco J. Bruno, MD, PhD, Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands, highlights many key points supporting the use of nCLE in characterization of pancreatic cysts. In terms of specificity and positive predictive value, the author concludes that results using nCLE "match or outweigh other available diagnostic modalities, including morphology (computed tomography, magnetic resonance imaging - magnetic resonance cholangiopancreatography, EUS), cyst fluid analysis, and EUS-guided pathology." The paper also confirms that EUS-guided nCLE can be executed quickly and provides instant results.
The editorial goes on to note that CLE could have applications beyond cyst differentiation, including diagnosis of pancreatic ductal adenocarcinoma and pancreatic intraepithelial neoplasia.
"The findings from the CONTACT 1 study provide strong additional evidence for continuing clinical investigations involving Cellvizio in the diagnosis of pancreatic cysts and in other applications. Mauna Kea Technologies remains on track to complete enrollment in its sponsored study CONTACT 2, a large-scale trial that will assess the use of Cellvizio in 200 patients. We look forward to providing an update on our progress with this important trial in the near future," Sacha Loiseau added.
The CONTACT 1 study included 31 patients and focused on the diagnosis of solitary pancreatic cystic lesions using nCLE. Among patients in the study, the presence of a specific superficial vascular network shown to be typical and highly characteristic of serous cystadenoma, a benign form of pancreatic cysts, was described. Using this sign, experts were able to differentiate the benign form of pancreatic cysts with a sensitivity of 69% and a specificity of 100%.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on leading innovation in endomicroscopy and optical biopsy. The company designs, develops and markets innovative tools to visualize and detect cell abnormalities in real time during standard gastrointestinal and pulmonary endoscopy procedures. The company's flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers with high-resolution cellular imaging of internal tissues. Large- scale, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians to more accurately detect early forms of diseases and make immediate treatment decisions. Designed to help physicians in their diagnoses, provide patients with better treatment and reduce hospital costs, the Cellvizio system can be used with practically all endoscopes. Cellvizio has 510(k) clearance from the United States Food and Drug Administration and CE Marking in the European Union for use in the gastrointestinal tract and the urinary and respiratory systems, for endoscopic exploration of the biliary and pancreatic ducts, and for fine-needle aspiration procedures. Cellvizio also obtained SFDA regulatory approval in China and MHLW approval in Japan.
For further information on Mauna Kea Technologies, visit http://www.maunakeatech.com
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