FDA Clears World’s First Single-Use Scope for Colonoscopies

The FDA granted approval this month for Invendo Medical to sell the world’s first single-use colonoscope. The new $200 sterile scope is expected to solve the problems associated with reprocessing scopes for colonoscopies.

According to Invendo, the current procedures for reprocessing endoscopes is “costly, overly challenging, manual-labor intensive and increases patients' risk for cross-contamination.”

A number of superbug outbreaks linked to improperly sterilized endoscopes have made national news in recent years, making the prospect of a sterile, disposable scope an attractive option for safely performing colonoscopies.

The invendoscopy E200 System will provide visualization and diagnostic/therapeutic access to the adult lower gastrointestinal tract (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery. The colonoscope component of the invendoscopy E200 System, called the invendoscope SC200, is a sterile single-use disposable device.

“Our one-of-a-kind technology provides a platform specifically tailored to address the need for device sterility during endoscopies, the importance of which has been underscored by various recent ‘superbug’ outbreaks in multiple U.S. hospitals,” said Timo Hercegfi, CEO of invendo medical. “The FDA clearance of the invendoscopy E200 System continues its pathway of validation, enabling our company to now provide endoscopists in the U.S. with a revolutionary technology that will allow them to perform colonoscopies with a system that significantly improves medical staff and patient safety while enhancing physician comfort during procedures.”  

Invendo will begin rolling out the new E200 system later this year, with a full launched planned for 2017.