NEW YORK and KISSING, Germany—Invendo medical announced this week that the company received 510(k) clearance by the U.S. Food and Drug Administration for the company's new C20 colonoscopy system, including the SC20 single-use colonoscope.
The invendoscope SC20 has features that are new to the specialty of colonoscopy, invendo reported. For instance:
• It is a single-use colonoscope with a working channel
• It is not pushed or pulled, but instead uses a computer-assisted "gentle drive technology"
• All endoscopic functions are performed using a handheld device
• It reduces force on the colon wall
A clinical trial with the company's colonoscope delivered convincing results with a >98 percent cecal intubation rate and lesions detected in 41 percent of screening subjects, according to invendo. 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 U.S. 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."
Based in New York, and Kissing (near Munich), Germany, invendo medical is a developer of disposable endoscopy products in the field of gastroenterology that are computer-assisted, hygienically safe and employ "no manual push."