Globus Medical Receives CE Mark for Excelsius GPS

By Julie A. Vetalice

Globus Medical (GMED) received approval under the CE Mark for the Excelsius GPS™ robotic trajectory guidance and navigation system. GPS supports minimally invasive and open orthopaedic and neurosurgical procedures, with applications in the cervical spine, sacroilium, long bones, cranium, etc.

GPS integrates with GMED implants and instruments, and is compatible with pre-op CT, intra-op CT and fluoroscopic imaging modalities.

GMED acquired Excelsius Surgical in 1Q14. At the time, the company expected FDA clearance in 2015, with commercial sales beginning in 2016. Per the 3Q16 earnings call, FDA clearance was filed in 4Q16; the system was showcased at both Eurospine and NASS last year.

Robotics + trauma products are expected to account for up to 15% of GMED's overall sales by 2020, per company estimates.

Sources: Globus Medical, Inc.; ORTHOWORLD Inc.

 

Product Labels: Robot-Assisted Systems, Spinal Fusion

Tags: CE Mark, Regulatory