Robotic endoscope specialist, invendo medical GmbH, tells us it has received CE Mark for the invendoscope™ SC200, the world’s first sterile, single-use colonoscope.
Background
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.
Based in the romantically named Kissing, near Munich, Germany (as well as New York), invendo medical GmbH focuses its efforts on the somewhat unromantic business of single-use and robotically-assisted endoscopy products in the field of gastroenterology and GI surgery. The company has several proprietary technologies in its first product, the sterile and single-use invendoscope™ SC200, and says it plans to introduce a full suite of other sterile and single-use GI endoscopes in the future.
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. 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.
Furthermore, invendoscopy™ technology is robotically-assisted and ergonomically designed to offer gastroenterologists greater control and enhance physician comfort while performing procedures.
The invendoscope™ SC200 received U.S. FDA 510(k) clearance earlier this year(2016).
invendo medical says it anticipates market introduction in 2017.
Company comments
“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.”
Source: Globe Newswire
published: December 5, 2016 in: Approval/Clearance, Endoscopy