U.S./German device company, invendo medical GmbH, has received U.S. FDA 510(k) clearance for the invendoscopy E200 System, which includes the invendoscope SC200 – the first and only sterile, single-use colonoscope.
Background
invendo Medical develops and distributes sterile, single-use and robotically-assisted HD endoscopy products in the field of gastroenterology and GI surgery. The company says its invendoscope SC200 is a simple, safe and effective solution to clinical and hygienic challenges, ensuring that a new colonoscope is always ready for physicians to use and that each patient receives his or her own device. The new advanced invendoscopy technology features robotic assistance for tip control and a new design to offer gastroenterologists greater control and enhanced comfort while performing procedures, says the press announcement.
The invendoscopy E200 System has been cleared by the FDA to 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, the invendoscope SC200, is a sterile single-use disposable device, a sterile and single-use colonoscope that eliminates the complex reprocessing of endoscopes, which is costly, overly challenging, manual-labor intensive and increases patients’ risk for cross-contamination. In addition, the invendoscope SC200 fits seamlessly into any existing clinical practice, with a low associated startup cost. The technology also improves practice efficiency by eliminating the need for scope cleaning, reprocessing and repairs; and the invendoscope SC200’s simplified setup allows for ease of use and fast turnaround.
Company comments
“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, Chief Executive Officer 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.”
“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. This unique control body coupled with the lightweight of the colonoscope provides a more comfortable and less tiring procedure for the healthcare 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,” said John Cifarelli, Chief Commercial Officer of invendo medical.
Source: Globe Newswire
