Endovascular navigation startup Centerline Biomedical has successfully completed a fifth preclinical study at Cleveland Clinic facilities to see how its surgical navigation system, the Intra-Operative Positioning System (IOPS), will perform in the marketplace.

The study demonstrated its ability to track IOPS instruments precisely and efficiently with enhanced three-dimensional (3D) visualization and without frequent exposure to cancer-causing ionizing radiation associated with current standard of care.

Endovascular surgeries often rely on X-ray fluoroscopy for stenting, a technology that provides limited two-dimensional visualization, leading to long procedure times while exposing surgeons and patients to damaging radiation.

IOPS, originally developed at Cleveland Clinic, uses a 3D model of a patient’s vascular system to track instruments precisely without ionizing radiation, with the goal of reducing procedure times, complication rates and overall costs. The mathematical algorithms used to generate the 3D model are currently being used in minimally invasive surgery, with future applications in surgical training and clinical decision support.

The study was led by Matthew Eagleton, MD, and Ezequiel Parodi, MD. Dr. Eagleton is chief of Massachusetts General Hospital’s Division of Vascular and Endovascular Surgery in Boston. Dr. Eagleton also serves as co-director of the Fireman Vascular Center and Thoracic Aorta Center at Massachusetts General, as well as chairing Centerline’s Scientific Advisory Board. Dr. Parodi is a vascular surgeon and endovascular specialist at the Cleveland Clinic’s Miller Heart and Vascular Institute and Scientific Advisor to Centerline, with associated financial interest in the company

Dr. Parodi used Centerline’s system for the first time in this study and tested the visualization and workflow functionality of IOPS. “I observed a high level view of vasculature along with a more magnified, localized view,” he said. “I don’t have to constantly change views to highlight areas of interest.”

Centerline, a Cleveland Clinic spinoff company founded in 2014, is a joint venture of G2 Group Ventures and Cleveland Clinic. The company has raised $12.7 million in funding to date. Centerline chairman and CEO Jai Gupta said this milestone study bolstered the view that IOPS is a novel technology that will disrupt the market, offering surgeons and the endovascular community something they’ve never seen before. VTN

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