The system won CE Mark clearance in the EU in early 2017 with indications for use in both minimally invasive and open procedures for orthopaedics and neurosurgery, including procedures for the spine, long bones and cranium. The system is designed to integrate with Globus Medical implants and instruments and is compatible with pre- and intra-operative CT and fluoroscopic imaging, the company said.
Globus Medical touted that the first European procedure using the ExcelsiusGPS was performed in October 2018 by Panagiotis Zoumpoulis at the Metropolitan Hospital in Athens, Greece, and that numerous other surgeries have been performed at the Fornaca Clinic in Turin, Italy and the Bonifatius Hospital in Lingen Germany.
“With the addition of ExcelsiusGPS we now offer patients seeking spine surgery a level of accuracy that was not possible without this technology. Our team is committed to providing the highest level of care to our patients by offering the latest advancements in robotic-assisted spine surgery at our facilities,” Franco Cenech of the Fornaca Clinic, who participated Italy’s first surgeries with the system, said in a press release.
Earlier this week, the FDA released a warning letter it sent to Globus Medical subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April.