The US Food and Drug Administration (FDA) has granted 510(k) clearance to Centerline Biomedical’s Intra-Operative Positioning System (IOPS), a device used in endovascular procedures to provide 3D visualisation.
The non-radiation-based surgical navigation system uses anatomical mapping algorithms and electromagnetic tracking to give surgeons 3D colour visualisation and guidance during procedures.
The holographic system, developed at Cleveland Clinic’s Heart and Vascular Institute (Cleveland, USA), offers an alternative to the current standard of care, X-ray fluoroscopy, which exposes surgeons and operating room staff to potentially dangerous radiation.
“Having worked closely with Centerline for almost five years, I am very pleased to see that IOPS will soon be commercially available,” remarks Matthew Eagleton, chief of Vascular Surgery at Massachusetts General Hospital (Boston, USA) and chair of the company’s scientific advisory board. “We hope to use this game-changing technology to revolutionise our approach to vascular procedures and imaging.”
This milestone, achieved working with regulatory partner JALEX Medical, will allow marketing and commercial use of IOPS for endovascular interventions in the descending aorta, though the underlying platform will be applicable to many other minimally invasive procedures in the future, a press release states. 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 research and development efforts will continue in parallel with Centerline’s upcoming market launch.