invendo medical completes pivotal clinical study
New York, NY / Kissing, Germany — January 4, 2010 — invendo medical, developer of a single use, no touch/no manual push and potentially pain-reduced colonoscope, announced that it has completed the pivotal clinical study that will serve as the basis for 510(k) notice submission.
The study enrolled 61 subjects in accordance with U.S. inclusion and exclusion criteria for colorectal cancer screening with colonoscopy. The key primary endpoint was the rate of reaching the cecum, which was achieved in 98% of the cases (60/61). There were no device-related adverse events. Sedation was used in less than 5% of the cases (3/61). Lesions were found in 25 subjects (41%), 87% of which were immediately addressed by intervention in the same session. The study was carried out in two centres, one academic, one hospital outpatient-based, with an international team of four investigators, two of whom have been newly introduced to the invendo system this year.
Berthold Hackl, CEO of invendo medical, said, “We are extremely pleased with those results and are now expediting the work on the 510(k) submission, which we are planning to file early in 2010. We are looking forward to making this additional option for the prevention of colorectal cancer available to US patients and we intend to work cooperatively with FDA in the 510(k) submission and review process.”
Prof. Dr. Douglas Rex, one of the Principal Investigators, said: “When I did my training cases, which was less than a handful, my feeling was that the advancement of this device to the cecum is to a high degree operator-independent. Now, after a double-digit number of more cases, this feeling has been reinforced. I anticipated there would be no device-related adverse event with the device, and there was none. I hope that the device will become available in the US soon.”
About invendo medical - www.invendo-medical.com
Based in New York, U.S.A. and Kissing (near Munich), Germany, invendo medical is a leading developer of disposable endoscopy products in the field of gastroenterology that are hygienically safe, employ “no touch/no manual push” remote control technology, and potentially reduce pain compared to conventional modalities.
Contact:
Timo Hercegfi, CFO
invendo medical Inc.
1225 Franklin Avenue, Suite #325
Garden City, NY 11530
phone U.S. +1 - 516 - 992 3479
phone GER +49 – 173 – 964 0092
fax U.S. +1 - 516 - 873 8881
email timo.hercegfi@invendo-medical.com
web www.invendo-medical.com
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Caution: Investigational Device. Limited by U.S. federal law to investigational use. The invendoscopy™ System is not available for sale in the United States. Only for clinical investigational use and exhibition purposes.