Olympus has announced 510(k) clearance for the new CleverCut3V Distal Wireguided sphincterotome, which enables more efficient and safer cutting during endoscopic procedures with improved visualization and precision placement, according to a press release.
The CleverCut coating on the single-use device provides insulation to the proximal end of the cutting wire, which helps prevent tissue damage and related complications that can occur from the wire cutting into duodenal folds during endoscopic procedures involving difficult anatomy or limited visibility, according to the press release. The device can be purchased in several configurations, including preloaded with a VisiGlide guidewire or sold separately, the release said.
“CleverCut3V DW with VisiGlide is the only short-wire sphincterotome with the coating’s presence over the proximal end of the cutting wire,” Vijay Jayaraman, MD, assistant professor at University of Nevada School of Medicine, said in the press release. “This has been particularly helpful in protecting the duodenum in case of overhanging folds. The smooth taper of the tip is atraumatic to the papilla and the guidewire strips away easily while still maintaining a good air seal to the c-channel, which is very important to my longer cases. Additionally, having the VisiGlide wire preloaded saves us time.”
According to the release, benefits of the device for advanced endoscopists include greater procedural efficiency from its advanced c-channel and intuitive guidewire insertion port, improved safety from its CleverCut coating and optimal knife orientation, smooth insertion during difficult cannulations from its refined 3.9 Fr tapered tip, and integration with VisiGlide guidewires.
“The shift in endoscopy from diagnosis-only to include increasingly more therapeutic measures is an exciting opportunity for endoscopists,” Richard Reynolds, executive vice president of sales, marketing and shared services of the Medical Systems Group at Olympus Corporation of the Americas, said in the press release. “Advancements to therapeutic technologies such as the CleverCut3V DW help facilities meet their health care reform goals of cost reduction through more efficient procedures, which ultimately benefits patients.”
Disclosures: Jayaraman reports he is a contracted consultant for Olympus. Reynolds reports he is an employee of Olympus.