NEW YORK and KISSING, Germany, March 8 /PRNewswire/ -- invendo medical announced today that the company has filed its 510(k) notice submission with the Food and Drug Administration for premarket clearance of the company's new C20™ colonoscopy system including the SC20™ single-use colonoscope. This is the first FDA submission for invendo medical in the United States.
The pivotal clinical trial with the company's single use, advancement-assisted colonoscope in 61 screenees has been completed in December 2009 with encouraging results. The device achieved a 98% cecal intubation rate (60 of 61 subjects), and, while sedation was available to all subjects and doctors upon request, less than 5% of the subjects requested a sedative during the study procedure. There also were no device-related adverse events observed during the study. Lesions were detected in 41% of the subjects.
The C20™ colonoscopy system has already received CE mark in Europe.
"Our initial commercial focus will be on the United States," said Berthold Hackl, CEO of invendo medical, "Therefore the submission for 510(k) clearance of our new colonoscopy system marks a major milestone in our company's history. We will give the further process with the U.S. Food and Drug Administration our full attention."
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 and employ "no manual push" remote control advancement technology.
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|SOURCE invendo medical|
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