Oftentimes a medical breakthrough involves a dramatic change in the way a procedure is performed or the invention of an entirely new technology that improves the diagnosis or treatment of a disease. Other times, a noteworthy innovation is as simple as a shape change at the end of a wire guide.
However simple it may seem, Cook Medical (Bloomington, Indiana) is hoping its latest innovation a closed distal loop wire guide will improve access to the biliary and pancreatic ducts and reduce the risk of serious complications associated with procedures like endoscopic retrograde cholangiopancreatography (ERCP).
Cook says its Fusion LoopTip wire guide is the first looped-tip wire guide in the industry. According to the company, the LoopTip delivers potentially less traumatic access and navigation of the pancreatobiliary ductal system when diagnosing and treating conditions of the biliary and pancreatic ducts including gallstones, malignant and benign strictures, and conditions gastroenterologists treat using ERCP.
ERCP is the most common complicated procedure within gastroenterology, Barry Slowey, VP of global sales and marketing for Cook's Endoscopy business unit, told Diagnostics & Imaging Week. It is a procedure that allows the physician, using an endoscope and X-ray, to deal with diseases in the liver and the pancreas. To access the pancreatobiliary system, the gastroenterologist uses a wire guide.
"We think of the wire guide as being the railroad tracks to get down into the biliary system," Slowey said.
Prior to ERCP being available physicians had to deal with conditions of the biliary and pancreatic ducts, such as gallstones, either with an open or laparoscopic procedure. Endoscopy offered a less invasive alternative, entering through one of the body's natural orifices, such as the mouth. Yet, even with this procedure, there is a complication rate. According to Cook, acute pancreatitis, sudden inflammation of the pancreas, can be a common, serious post-ERCP side effect and is often a result of difficult or railed cannulation. Failed cannulation occurs when a patient goes in for ERCP and the doctor is not able to get access at all so the patient has to come back later for a repeat procedure, Slowey said.
When Cook set out to design the LoopTip, the company asked itself how it could make improvements on the wire guide that could potentially reduce the risks of these complications, Slowey told D&IW. Cook worked with a Latin American doctor from Chili, Juan-Carlos Ayala, MD, who looked at this problem for many years and found that the shape of the wires was not the best for accessing the duct. He came up with the idea of having a closed loop on the tip of the wire guide.
"That closed loop basically allows the physician to get access to the duct much more easily than a straight wire did," Slowey said.
Using the LoopTip, Ayala found he was able to access the pancreatic duct 98% of the time. He also worked with less experienced doctors and found that they were able to get access about 90% of the time, Slowey said.
Ayala approached Cook with the idea about six years ago and at first the company was a little bit skeptical, Slowey said. But Ayala did a lot of animal work in Chile and the company has been actively working on the project for somewhere between two and three years, he said.
Cook did a limited release of the device in the U.S. about a year ago and received some feedback from physicians that the tip was not visible enough under fluoroscopy. Slowey said the version of the LoopTip being launched this week has a radiopaque coil spring that provides "excellent" fluoroscopic visibility.
In addition, the spiral markings extending to the distal end of the wire guide provide an endoscopic view of the wire guide's movement during cannulation, the company said. The wire guide also comes in a variety of lengths to suit physician preference.
Designed with a nitinol core, the LoopTip wire guide is engineered to flex and deflect toward the open pathway, according to Cook. This delivers potentially less traumatic access and improved navigation of the pancreatobiliary ductal system, decreasing the risk of failed cannulation, perforation and post-ERCP pancreatitis, the company noted. The nitinol core also provides kink resistance and shape retention.
Cook said ERCP requires cannulation, a method by which gastroenterologists gain access to the biliary and pancreatic ducts with either a device, such as a sphincterotome, or a wire guide. To meet the needs of gastroenterologists that prefer one method of cannulation over the other, the company says it offers an array of DomeTip sphincterotomes, like the Fusion OMNI-Tome, for device cannulation and a line of wire guides that is being augmented by the launch of the Fusion LoopTip.
"This Fusion wire is the only loop-tipped wire guide on the market today, helping to maintain Cook Medical's position as the only full-line endoscopy supplier in the market," Slowey said. "The advancements of the LoopTip, including its excellent fluoroscopic visibility and flexibility, enable physicians to perform a less traumatic procedure. In turn, physicians have the opportunity to leverage best-in-class endoscopic devices that vastly improve patient care."