NuVasive has revealed that its Pulse platform received CE Mark approval for its latest design update and clinical evaluations are now underway in multiple countries throughout Europe.
Pulse is designed to act as one platform to assist surgeons in all spine procedures. It integrates radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring, and spinal alignment tools into a single platform.
Massimo Calafiore, executive vice president, global business units at NuVasive, said: “The latest CE Mark approval and clinical evaluations are key commercialisation milestones for the Pulse platform and further our plan for an expanded global launch later this summer.
“There is a substantial opportunity for enabling technology adoption in spine surgery, and we are leveraging our expertise in proceduralisation to introduce Pulse. This next generation of enabling technology has applications that can be utilised in every spine procedure.”
The Pulse platform aims to increase safety, efficiency, and procedural reproducibility, while addressing some of the most common clinical challenges in spine surgery. NuVasive say that it is currently the only enabling technology platform with the ability for utilisation in 100% of spine procedures and throughout the entire operating room (OR) workflow.
Jacques Müller-Broich, head of the spine specialty centre and spinal orthopaedics at University Hospital in Frankfurt, Germany, added: “In running a comprehensive spine program, I treat patients with a variety of complex spine pathologies and Pulse has utility in every surgical case.
“The integration of C-arm image stitching and spinal alignment tools provide the ability to measure and correct alignment in real time—something I could not do with prior technologies. I am impressed by the results I am experiencing with Pulse and look forward to continue using this innovative platform in the OR.”