Globus Medical (NYSE:GMED) said yesterday that it launched its ExcelsiusGPS robotic guidance and navigation system in the global market, having completed installations of the system in several European countries.
The ExcelsiusGPS system won CE Mark clearance in the EU in early 2017 with indications for use in both minimally invasive and open procedures for orthopedics and neurosurgery, including procedures for the spine, long bones and cranium. The system is designed to integrate with Globus Medical implants and instruments, with compatibility with pre- and intra-operative CT and fluoroscopic imaging, the company said.
“Surgeons and hospital administrators in the United States have shown tremendous levels of interest in ExcelsiusGPS since it first launched domestically at the end of 2017. Users have realized the system’s ability to help advance patient care and provide tangible benefits for surgeons and their staff. As we begin to scale our efforts abroad, we have seen similar levels of enthusiasm within the international surgeon community and look forward to the continued adoption of ExcelsiusGPS into these markets,” CEO Dave Demski said in a prepared statement.
The Audobon, Penn.-based company touted that the first European procedure using the ExcelsiusGPS was performed at Athens, Greece’s Metropolitan Hospital by Dr. Panagiotis Zoumpoulis in October, and that numerous other surgeries have bene performed at Italy’s Fornaca Clinic and Germany’s Bonivatius Hospital.
“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,” Dr. Franco Cenech of the Fornaca Clinic, who participated Italy’s first surgeries with the system, said in a press release.
“ExcelsiusGPS is truly a revolutionary technology designed to improve surgeon wellness and patient care. We are excited about the potential impact that robotic guidance and navigation may have in improving screw placement accuracy, MIS efficiency, and reducing radiation exposure,” Peter Klassen of Bonifatius Hospital said in prepared remarks.
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.