Endovascular 3D navigation system without ionising radiation completes preclinical study

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Endovascular navigation startup Centerline Biomedical has successfully completed a fifth preclinical study at Cleveland Clinic facilities evaluating its surgical navigation system, the Intra-Operative Positioning System (IOPS). The study was the company’s most noteworthy study to date; demonstrating ability to track sensorised IOPS instruments precisely and efficiently with enhanced three-dimensional (3D) visualisation and without frequent exposure to cancer-causing ionising radiation associated with current standard of care.

Endovascular surgeries often rely on X-ray fluoroscopy for stenting, a technology that provides limited two-dimensional visualisation, 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 ionising 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 to revolutionise minimally invasive surgery, with future applications in surgical training and clinical decision support.

The study was led by Matthew Eagleton and Ezequiel Parodi. Eagleton is chief of Massachusetts General Hospital’s Division of Vascular and Endovascular Surgery (Boston, USA). An international thought leader on minimally-invasive aortic repair, 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. Parodi is a vascular surgeon and endovascular specialist at the Cleveland Clinic’s Miller Heart and Vascular Institute (Cleveland, USA) and Scientific Advisor to Centerline, with associated financial interest in the company.

Parodi used Centerline’s system for the first time in this study and tested the visualisation and workflow functionality of IOPS, commenting, “I observed a high level view of vasculature along with a more magnified, localised view. 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. This fifth preclinical study allows Centerline to visualise how the IOPS technology will function once entering the market, while offering confidence in the seamless integration into current workflow. The company has raised US$12.7 million in funding to date. Centerline chairman and CEO Jai Gupta was delighted by the results of the study, stating, “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.”

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