November 17, 2019
Centerline Biomedical Launches IOPS Intraoperative Positioning System
November 18, 2019—Centerline Biomedical, Inc., a spinout company from Cleveland Clinic, announced the successful first-in-human clinical use of the company’s IOPS intraoperative positioning system with an intuitive, interactive, color three-dimensional display for minimally invasive vascular repairs.
The company is launching the IOPS system at the VEITHsymposium held November 19–23 in New York, New York, where Matthew Eagleton, MD, Chief of Vascular and Endovascular Surgery at Massachusetts General Hospital in Boston, Massachusetts, will be speaking about the device. Broad commercialization of the system is anticipated to begin before the end of this year.
In July 2019, the company announced FDA 510(k) clearance to market IOPS as a nonradiation-based navigation system for minimally invasive surgery. IOPS was developed at Cleveland Clinic's Heart and Vascular Institute in Cleveland, Ohio.
The present FDA clearance is for aortic interventions; the technology has significant patent protection and a robust lifecycle plan including application in structural heart and peripheral arterial interventions, advised the company.
Used in conjunction with standard two-dimensional grayscale x-ray fluoroscopic imaging, IOPS yields improved visualization and guidance while reducing the need for contrast dye and minimizing prolonged exposure to harmful radiation.
The first procedures—which involved repairing aortic aneurysms in two patients—were conducted by Ezequiel Parodi, MD, and staff at the Clinical Center of Serbia Vascular Center in Belgrade, Serbia, which is a high-volume vascular center treating two aneurysms per day at the world's third-largest hospital. Dr. Parodi is an endovascular aortic interventionalist from the University of North Carolina’s Division of Vascular Surgery in Chapel Hill, North Carolina.
According to Centerline Biomedical, attending surgeon Igor Končar, MD, was impressed that IOPS enabled manipulation of guidewires and catheters even without active radiation. He commented in the company’s announcement, "Using IOPS, I released the fluoroscopy pedal and felt a sense of calm which I never had before, because for the first time I was navigating without hearing the pumps and sounds of the fluoro system." Dr. Končar also was able to identify a possible new use for the system, stating, "We cannulated the abdominal aortic aneurysm contralateral limb on the first attempt with IOPS." Both patients are doing well and the surgeons are pleased with the system. Dr. Parodi added, "This two-patient series truly shows the potential impact of the IOPS technology."