Surgical navigation startup Centerline Biomedical, a Cleveland Clinic spin-off company, has announced the successful completion of the first in a series of clinical cases in the USA as it begins limited launch of its IOPS (Intraoperative positioning system) technology platform. The US Food and Drug Administration (FDA)-cleared technology is being deployed at Cleveland Clinic (Cleveland, USA) to begin with, followed by other leading intuitions, in preparation for larger scale multicentre clinical studies.
First employed clinically overseas in October 2019, IOPS offers an alternative to the heavy dependence on 2D fluoroscopic X-ray imaging in minimally-invasive vascular surgery. Cleared as an adjunct to fluoroscopy for descending aortic interventions, IOPS provides interactive, colour, 3D visualisation for precise surgical navigation of guidewires and catheters manipulated inside the body.
Cleveland Clinic vascular surgeon Behzad Farivar performed the surgery. This first US clinical case represents a leap forward for the technology, which has rapidly progressed from initial concept to today’s commercially-ready solution. “Considering we were in the research lab a scant five years ago, we could not be more excited about kicking this series off,” commented Vikash Goel, the company’s CTO. “This positive first experience confirms our belief in our technology’s value and transformative potential.”
This milestone comes on the heels of several key achievements made over the past year, including achieving FDA clearance, closing on US$10 million of financing, and recruitment of high-powered personnel for key operational, sales, and advisory roles. “We continue to execute on our goals despite the challenging times our world faces,” said Centerline CEO Philip D Rackliffe. “Transitioning back to providing elective care will be a tumultuous process for hospitals, and clinical experts believe IOPS can help streamline this process with enhanced safety.”