First surgical case launches multicenter prospective clinical study of FDA-cleared product to support international market entry
CLEVELAND, Dec. 15, 2020 /PRNewswire/ — Centerline Biomedical, Inc. (Centerline) announced Tuesday the completion of the first surgical case in its MOTION clinical study of its innovative Intra-Operative Positioning System (IOPS™) surgical navigation platform. The FDA-cleared technology is already being deployed in a controlled launch at Cleveland Clinic and other leading institutions in the United States. 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 US 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 3-D color image guidance using electromagnetic tracking much like a miniaturized 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 aortic repair (EVAR) procedures. The study will consist of 30 total cases divided among Cleveland Clinic and UNC Medical Center.
This first case was performed at Cleveland Clinic’s Miller Family Heart, Vascular & Thoracic Institute by the Principal Investigator Dr. Francis Caputo, a specialist and expert in complex aortic aneurysmal disease. “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.”
The launch of this study is the latest in a series of significant milestones for the startup, including deployment of IOPS™ at 5 leading US hospital systems. Company CEO Philip D. Rackliffe noted that these achievements came despite challenges across the world. “It’s 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,” said Centerline CEO Philip D. Rackliffe. “The demand for IOPS™ is grounded in the need for an endovascular surgical technology that can minimize challenges associated with the decades-old standard of fluoroscopy.”
SOURCE Centerline Biomedical