invendo medical receives CE Mark for world’s first sterile single-use colonoscope

Dec 7 2016

invendo medical GmbH, a leading developer and distributor of sterile, single-use and  robotically-assisted endoscopy products in the field of gastroenterology and GI surgery, today announced it has received CE Mark for the invendoscope™ SC200, the world’s first sterile, single-use colonoscope.

“Our revolutionary technology uniquely addresses the significant challenges associated with the cleaning and disinfecting of traditional reusable endoscopes by providing an ergonomically advanced endoscope that offers both sterility and single use,” said Timo Hercegfi, Chief Executive Officer of invendo medical. “The CE Mark is a significant accomplishment for our company, which enables us to provide endoscopists in Europe with a more advanced technology to perform colonoscopies and a system that enhances patient safety over current devices.”

As part of the new invendoscopy™ E200 System, the invendoscope™ SC200 is a sterile and single-use colonoscope that eliminates the main challenge of gastrointestinal endoscopy: the complex reprocessing of endoscopes and therefore patients’ risk for cross-contamination.

Current infection control guidelines require that devices such as colonoscopes only be high-level disinfected, as these devices are not able to sustain the high-temperature heat of sterilization or the long process of gas sterilization in the longer term. Though disinfection eliminates most viable microorganisms, it does not remove all of them, creating opportunities for cross-contamination among patients. In fact, more healthcare-associated infection outbreaks have been linked to contaminated endoscopes than to any other medical device.

The invendoscope™ SC200 is a simple, safe and effective solution to clinical and hygienic challenges, ensuring that every patient has a personal endoscope. The device is always ready for physicians to use, and this advanced technology leads endoscopy ergonomics into the 21st century.

In addition to addressing an unmet need in GI endoscopy infection control, invendoscopy™ technology is robotically-assisted and ergonomically designed to offer gastroenterologists greater control and enhance physician comfort while performing procedures.

The invendoscope™ SC200 also received 510(k) clearance from the U.S.

Food and Drug Administration earlier this year. The company anticipates market introduction in 2017.