Novel Device Shown to Dramatically Improve Scope Stability and Control for Gastroenterologists of All Skill Levels
Neptune Medical, a leader in medical device innovation, announced positive new data from two studies presented at the prestigious Digestive Disease Week conference demonstrating that its Pathfinder Endoscope Overtube significantly improves endoscope control and completion of difficult upper and lower endoscopic procedures.
Colonic endoscopic submucosal dissection (ESD) can be challenging for many GIs due to the unique configuration of the anatomy, but it has been shown to achieve higher rates of en block and R0 resection leading to a higher curative resection rate. With this in mind, investigators with varying ESD expertise from Baylor St. Luke’s Medical Center, Texas, initiated a prospective, single-center, post-market, randomized controlled trial in 46 patients to study the ability of the Pathfinder device to enhance ESD when compared to conventional ESD in patients requiring advanced polyp resection.
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In interim results from the study, all ESD procedures facilitated with the Pathfinder device were completed. The Pathfinder-enabled procedures demonstrated dramatically improved scope stability (72.7% vs. 20.8% n= <0.001) and retroflexion ability (94.7% vs. 47.4%; n=0.001) when compared to conventional ESD.
“In this study, the novel rigidizing overtube facilitated colonic ESD by improving endoscope stability and control without compromising outcomes compared to conventional ESD. The Pathfinder procedure made ESD achievable and successful for all three of our investigators, despite varying experience levels with the procedure. There is also a trend towards higher procedure speed with the use of the overtube,” said Mohamed Othman, MD, Chief of Gastroenterology at Baylor St. Luke’s Medical Center, Texas, and principal investigator of the study. Co-principal investigators included Tara Keihanian, MD, and Salmaan Jawaid, MD, also with Baylor.
A second study – a retrospective multicenter study performed at the University of South Florida and Cleveland Clinic Florida – examined the ability of the Pathfinder device to enable complete endoscopic procedures across looping colon, deep enteroscopy, and endoscopic retrograde cholangiopancreatography (ERCP) in 42 adult patients.
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In a patient population where 71% of patients had previously had incomplete endoscopic procedures, interim results from the study showed that the Pathfinder device facilitated a 97% completion rate and 100% technical success in these challenging procedures, with no device-related adverse events.
“In this first multicenter study of the Pathfinder rigidizing overtube, we found that the device was safe and enabled high technical and clinical success rates in endoscopic procedures technically challenged by looping, redundant/tortuous colons, and surgically altered anatomy. In addition, the device facilitated completion of a prior incomplete endoscopy,” said Pushpak Taunk, MD, Associate Professor of Medicine, Director of Advanced Endoscopy Fellowship with the University of South Florida’s Division of Digestive Disease and Nutrition, and senior author on the study.
The Pathfinder Endoscope Overtube is designed to manage loop formation, easily navigate tortuous anatomy, and control the scope tip for a wide variety of diagnostic and therapeutic GI procedures. Its unique ability to instantly toggle from flexible to rigid, and back again, creates a stable platform for retroflex RO resections, with no loss of position, offering greater control to operators of all skill levels.
“These studies validate that our Pathfinder technology safely enhances stability and control for GIs with varied skill levels, even across the most challenging procedures,” said Alex Tilson, Founder and CEO at Neptune Medical. “We believe this evidence supports universal use of the device in difficult endoscopic procedures to improve completion rates, which would speed treatment, improve patient outcomes, and potentially improve healthcare costs associated with failed colonoscopy.”
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Source – businesswire
