Centerline Biomedical Begins MOTION Study to Support European Approval of IOPS Technology

December 15, 2020—Centerline Biomedical, Inc. announced the completion of the first case in the MOTION clinical study of the company’s IOPS intraoperative positioning system.

Centerline’s IOPS, which was developed at Cleveland Clinic’s Heart and Vascular Institute in Cleveland, Ohio, is used during endovascular aortic interventions to allow navigation and placement of catheters and guidewires with reduced dependence on x-ray fluoroscopy. The technology serves as an adjunct to fluoroscopy by providing high-definition, three-dimensional color image guidance using electromagnetic tracking.

According to the company, the MOTION study will be composed of 30 patients at the Cleveland Clinic and UNC Medical Center in Chapel Hill, North Carolina. The primary objective of the study is to evaluate the effectiveness and safety of the IOPS technology in providing accurate navigation during endovascular aortic repair procedures. Findings from the study will be used to support the company’s submission for market clearance in Europe and other international markets.

Principal Investigator Francis Caputo, MD, enrolled the first patients at Cleveland Clinic’s Miller Family Heart, Vascular, & Thoracic Institute.

“This technology provides a promising future in endovascular aortic interventions,” commented Dr. Caputo in Centerline’s announcement. “It not only provides accuracy as the aorta and its branches are navigated but, most importantly, has the potential to reduce harmful radiation exposure to both surgeons and patients.”

In July 2019, Centerline announced FDA 510(k) clearance to market IOPS as a nonradiation-based navigation system for minimally invasive surgery. The company introduced IOPS in November 2019 at the VEITHsymposium in New York, New York, which was followed by commercialization of the system in a controlled launch at the Cleveland Clinic and other leading institutions in the United States.