Centerline Biomedical has received 510(k) clearance from the US FDA to market its flagship product, the intraoperative positioning system (IOPS). A press release reports that IOPS is a non-radiation-based surgical navigation system for minimally invasive surgery that leverages anatomical mapping algorithms and electromagnetic tracking technology to provide 3D colour visualisation and guidance in real time during endovascular procedures. It adds that the system, developed at Cleveland Clinic’s Heart and Vascular Institute, addresses the need for a path away from X-ray fluoroscopy.
Once IOPS is on the market, Centerline hopes to show significant value to the technology by reducing procedure cost while improving radiation safety and patient outcomes. The FDA approval, which was achieved by Centreline Biomedical working with its regulatory partner Jalex Medical, will allow marketing and commercial use of IOPS for endovascular interventions in the descending aorta. However, the aim is for 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 an NIH small business grant. The company’s R&D efforts will continue in parallel with Centerline’s upcoming market launch.
Matthew Eagleton, chief of vascular surgery at Massachusetts General Hospital and Chair of the company’s Scientific Advisory Board, says: “Having worked closely with Centerline for almost five years, I am very pleased to see that IOPS will soon be commercially available. We hope to use this game-changing technology to revolutionise our approach to vascular procedures and imaging.”
Jim Zalar, general manager of Business Solutions at Cleveland Clinic Innovations and Cleveland Clinic’s appointee to the company’s Board of Directors, comments: “To date, Cleveland Clinic has partnered with some 87 companies; among these, Centerline has been particularly rewarding and we are very excited about them having received 510(k) clearance. Most certainly as partners, shareholders, and prospective customers, we at Cleveland Clinic look forward to continuing support of the exciting research and commercialisation efforts of this rapidly growing company.”