Olympus has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Endocuff endoscopic device.
The approval has been granted to improve adenoma detection rate (ADR) during colonoscopy over standard colonoscopy.
According to the company, the Endocuff is the previous iteration of its recently launched Endocuff Vision.
An FDA meta-analysis has showed that the Endocuff results in a statistically significant and clinically relevant improvement in ADR compared against unassisted colonoscopy.
Its design enables manipulation of bowel folds for maximized visualization of mucosa.
Endocuff and Endocuff Vision are devices, which attach to the distal end of a colonoscope with multiple flexible arms that fold within the product during intubation and forward movement and open out when drawn backward, helping to control the field of view.
Both devices will allow to minimize difficulties associated with looping of the scope, intubation force and insertion resistance, as well as mucosal trauma.
The flexible arms of Endocuff Vision slide into the body of the device during intubation, enabling to avoid the blocking of forward movement.
The arms open and smooth the folded bowel for inspection, everting large mucosal folds and offering clear views of mucosa previously difficult to visualize
During withdrawal, the flexible arms are said to decrease the risk of sudden slippage and manipulate colonic folds, helping to carry out in-depth examination.
Olympus America endoscopy division group president Kurt Heine said: “The Endocuff is the first colonoscope technology to be cleared by the FDA to claim improved adenoma detection rates.
“Since the time that the industry has been using ADR as a standard, Olympus has been dedicated to helping its customers achieve ADR improvements – which can result in better quality of care, reduced cost, and enhanced patient satisfaction.”
Image: FDA has given 510(k) clearance for Olympus Endocuff claim that the device results in a statistically significant and clinically relevant improvement in adenoma detection rate compared to unassisted colonoscopy. Photo: courtesy of Olympus America.