May 4, 2020
First Clinical Case Performed With Centerline Biomedical IOPS Navigation System
May 4, 2020—Centerline Biomedical, Inc., a Cleveland Clinic spin-off company focused on surgical navigation technology, has announced the completion of the first in a series of clinical cases in the United States in a limited launch of the company’s endovascular IOPS intraoperative positioning system platform.
The FDA-cleared IPOS is being deployed first at the Cleveland Clinic in Cleveland, Ohio, and then at other leading institutions in preparation for larger-scale multicenter clinical studies. Behzad Farivar, MD, a vascular surgeon at Cleveland Clinic, performed the first United States clinical case.
According to the company, IOPS is cleared as an adjunct to fluoroscopy for descending aortic interventions. It provides interactive, color, three-dimensional visualization for precise surgical navigation of guidewires and catheters manipulated inside the body. The technology offers an alternative to two-dimensional fluoroscopic X-ray imaging in minimally invasive vascular surgery.
In July 2019, the company announced FDA 510(k) clearance to market IOPS as a nonradiation-based navigation system for minimally invasive surgery. The first-in-human clinical use of the IOPS was announced in November 2019 when the system was launched at the VEITHsymposium in New York, New York. The IOPS was first employed clinically overseas in October 2019.