invendoscope SC200, the world's first sterile, single-use colonoscope, receives CE Mark-invendo medical GmbH.
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, announced it has received CE Mark for the invendoscope SC200, the world's first sterile, single-use colonoscope.
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.
Comment:The invendoscope SC200 also received 510(k) clearance from the FDA earlier this year. The company anticipates market introduction in 2017.