The FDA has granted 510(k) clearance to the invendoscopy E200 system

The FDA has granted 510(k) clearance to the invendoscopy E200 system, which includes the first and only sterile, single-use colonoscope, the manufacturer announced.

The disposable invendoscope SC200 (invendo medical) eliminates the need for scope reprocessing, which is costly, time consuming and carries a risk for microbial cross-contamination between patients, according to the press release.

“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,” Timo Hercegfi, CEO of invendo medical, said in the press release. “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.

The invendoscopy E200 system provides visualization and diagnostic/therapeutic access to the lower GI tract in adults, and the included invendoscope SC200 is designed to provide greater control and ease-of-use to the physician, including robotic assistance for tip control. The platform also has a low associated startup cost, according to the press release.

“In addition to the clinical benefits associated with reducing potential cross-contamination, the ergonomic design of the invendoscope SC200 offers a ScopeController that contours to the physician’s hand and can be used attached or detached to the endoscope,” John Cifarelli, chief commercial officer of invendo medical, said in the press release. “This unique control body coupled with the light weight of the colonoscope provides a more comfortable and less tiring procedure for the health care provider. The invendoscope SC200 also includes a unique tip for full retroflection in various segments of the colon, enabling inspection behind colonic folds, which is key to a comprehensive diagnosis during colonoscopies.”