30.06.2021 13:36:36

NuVasive Receives CE Mark Approval For Pulse Platform; Starts Global Clinical Evaluations

(RTTNews) - NuVasive, Inc. (NUVA), a spine technology company, announced Wednesday that the Pulse platform received CE Mark approval for its latest design update. The company said clinical evaluations are underway in multiple countries throughout Europe.

Pulse is a first-of-its-kind technology that integrates radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring, and spinal alignment tools into a single platform.

According to the company, the platform is currently the only enabling technology platform with the ability for utilization in 100% of spine procedures and throughout the entire operating room or OR workflow, allowing surgeons to easily access multiple technologies from a condensed footprint.

Pulse is designed to increase safety, efficiency, and procedural reproducibility in spine surgery, while addressing some of the most common clinical challenges.

Massimo Calafiore, executive vice president, Global Business Units at NuVasive, said, "The latest CE Mark approval and clinical evaluations are key commercialization 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 proceduralization to introduce Pulse."

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