Centerline Biomedical recently announced completion of the first surgical case in the MOTION clinical study of the company’s intraoperative positioning system (IOPS) surgical navigation platform. The technology has been cleared by the US Food and Drug Administration (FDA) and is already being deployed in a controlled launch at Cleveland Clinic (Cleveland, USA) and other institutions in the USA. The MOTION study will be used to support the company’s submission for market clearance in Europe and other international markets.
First clinically deployed overseas in 2019, and with many cases completed in the USA in 2020, IOPS is used during endovascular aortic interventions and allows navigation and placement of catheters and guidewires with reduced dependence on X-ray fluoroscopy, to which it serves as an adjunct, providing high-definition 3D colour image guidance using electromagnetic tracking much like a miniaturised form of GPS.
The primary objective of the MOTION study is to formally clinically evaluate the effectiveness and safety of the technology in providing accurate navigation during endovascular aneurysm repair (EVAR) procedures. The study will consist of 30 total cases divided among Cleveland Clinic and UNC Medical Center (Chapel Hill, USA).
This first case was performed at Cleveland Clinic’s Miller Family Heart, Vascular & Thoracic Institute by the principal investigator Francis Caputo. “This technology provides a promising future in endovascular aortic interventions. 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,” he commented.
The launch of this study is the latest in a series of significant milestones for the start-up, including deployment of IOPS at five leading US hospital systems. Company CEO Philip D Rackliffe noted that these achievements came despite challenges across the world. “It is one thing to have interest in a compelling new technology under normal circumstances, but it is entirely another to demonstrate success and sales in the midst of a pandemic,” he said. “The demand for IOPS is grounded in the need for an endovascular surgical technology that can minimise challenges associated with the decades-old standard of fluoroscopy.”