FDA Clears Centerline's IOPS Intraoperative Positioning System

July 10, 2019—Centerline Biomedical, Inc. announced that the company has received FDA 510(k) clearance to market its IOPS intraoperative positioning system. IOPS, which was developed at Cleveland Clinic's Heart and Vascular Institute in Cleveland, Ohio, is a nonradiation-based surgical navigation system for minimally invasive surgery.

According to Centerline, IOPS leverages anatomical mapping algorithms and electromagnetic tracking technology to provide three-dimensional color visualization and guidance in real time during endovascular procedures. The system addresses the need for a path away from x-ray fluoroscopy, which is currently the standard of care, despite severe visualization challenges.

The FDA clearance will allow marketing and commercial use of IOPS for endovascular interventions in the descending aorta. Centerline hopes to show significant value of the technology by reducing procedural costs while improving radiation safety and patient outcomes.

The company noted that the underlying platform will be applicable to many other minimally invasive procedures in the future. Such future indications may include structural heart interventions, an application the company is currently exploring with funding from a National Institutes of Health small business grant.

Matthew Eagleton, MD, who is Chief of Vascular Surgery at Massachusetts General Hospital in Boston, Massachusetts, and Chair of Centerline's Scientific Advisory Board, commented in the company announcement, "Having worked closely with Centerline for almost 5 years, I am very pleased to see that IOPS will soon be commercially available. We hope to use this game-changing technology to revolutionize our approach to vascular procedures and imaging."