Cleveland, Ohio: Building on a study performed in May, Centerline Biomedical, Inc. successfully completed two additional preclinical studies evaluating its advanced surgical navigation system known as IOPS, the Intra-Operative Positioning System. The studies demonstrated the ability to track navigation of catheters and guidewires precisely, with enhanced 3-D visualization, and without the harmful effects associated with the current standard of care.
Endovascular surgeries currently rely on X-ray fluoroscopy, which provides limited two-dimensional visualization, resulting in long procedure times while exposing surgeons and patients to cancer-causing ionizing radiation. IOPS, a technology originally developed by Cleveland Clinic, uses a 3-D model of a patient’s vascular system to track instruments precisely without X-ray exposure, with the goal of reducing procedure times, complication rates, and overall costs.
These studies were led by Cleveland Clinic surgeon Dr. Matthew Eagleton, an international thought leader on minimally-invasive aortic repair and chair of Centerline’s Scientific Advisory Board, with associated financial interest in the company; Dr. Mark Farber, Director of the University of North Carolina Aortic Center, and Dr. Dipankar Mukherjee, Chief of Vascular Surgery for Inova Fairfax Hospital in Virginia, also participated in these studies.
Dr. Eagleton served as Principal Investigator for these studies but began by introducing the system to Drs. Farber and Mukherjee to establish IOPS’ navigational capabilities and ease of use with minimal training. Dr. Farber, using the system for the first time, noted, “This is great. We navigated to all four target vessels without any fluoroscopy. This is a realistic representation of anatomy and you can see real-time changes and movement of the catheter.”
Dr. Mukherjee also noted the value of IOPS, adding, “I was intrigued by the possibility of using this technology for all vascular interventions. If patient and physician are protected from radiation for more common procedures, the impact of this technology becomes even more profound.”
Concluding, Dr. Eagleton remarked, “This second round of work verified our ability to navigate the aorta and its branches, selecting the celiac artery, superior mesenteric artery, and renal arteries with the use of fluoroscopy limited to verification of catheter location. This technology will limit the need for extensive fluoroscopy units and provide more detailed anatomy that can be imaged while navigating through it. It will revolutionize vascular surgery.”
Centerline, a Cleveland Clinic spinoff company founded in 2014, is a joint venture of G2 Group Ventures and Cleveland Clinic. Completing this set of studies with a working manufacturing prototype of the IOPS technology is a significant milestone for the rapidly growing fledgling company. Centerline Chairman and CEO Dr. Jai Gupta congratulated his team, stating, “The successful completion of this round of studies advances our mission to commercialize this highly innovative technology. These studies represent a key step in taking us to FDA submission with market entry targeted later next year.”