invendo medical Announces 510(k) Clearance by FDA for Advancement-Assisted Single-Use Colonoscopy System
Clearance by FDA makes new endoscope for colon cancer screening available to U.S. patients
NEW YORK and KISSING, Germany, Feb. 24, 2012 /PRNewswire/ -- invendo medical announced today that the company received 510(k) clearance by the U.S. Food and Drug Administration of the company's new C20™ colonoscopy system including the SC20™ single-use colonoscope.
The invendoscope™ SC20 has several features that are new to the field of colonoscopy:
- it is a single-use colonoscope with a working channel
- it is not pushed or pulled, but uses a computer-assisted gentle drive technology
- all endoscopic functions are performed using a handheld device and
- it reduces forces on the colon wall
A clinical trial with the company's colonoscope delivered convincing results with a >98% cecal intubation rate and lesions detected in 41% of screening subjects. No device-related adverse events were observed during the study.
The C20™ colonoscopy system has already received CE mark in Europe.
"We are very proud to have achieved the most significant milestone in our company's history so far," said Berthold Hackl, CEO of invendo medical, "We are extremely excited to be bringing this new colonoscopy system to the US market. We believe that the invendo system reduces the burden associated with current conventional systems and that it may help to improve colonoscopy compliance rates, one of the key factors affecting the future incidence of colorectal cancer."
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" computer-assisted, gentle advancement technology.
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