CE Mark Granted to NuVasive’s Pulse Platform

NuVasive Inc.’s Pulse platform has received CE Mark approval for its latest design update, and clinical evaluations are underway in multiple European countries. 
 
“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,” said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. “There is a substantial opportunity for enabling technology adoption in spine surgery, and we are leveraging our expertise in proceduralization to introduce Pulse. This next generation of enabling technology has applications that can be utilized in every spine procedure.”
 
Pulse is a first-of-its-kind technology that integrates radiation reduction,¹ imaging enhancement, rod bending, navigation, intraoperative neuromonitoring, and spinal alignment tools into a single platform. It is currently the only enabling technology platform with the ability for utilization in 100 percent of spine procedures² and throughout the entire operating room (OR) workflow, allowing surgeons to easily access multiple technologies from a condensed footprint. Pulse is designed to increase safety, efficiency, and procedural reproducibility, while addressing some of the most common clinical challenges in spine surgery.
 
“In running a comprehensive spine program, I treat patients with a variety of complex spine pathologies and Pulse has utility in every surgical case,” said Dr. Jacques Müller-Broich, head of the spine specialty center and spinal orthopedics at University Hospital in Frankfurt, Germany. “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.”
 
Next month, NuVasive will feature the Pulse platform at the following industry events in San Diego:

• Korean American Spine Society (July 1-3): Demonstrating Pulse and its procedural workflow with X360. On July 2, Dr. Stephen Ryu will lead an exclusive Pulse lab at the NuVasive West Coast Experience Center to demonstrate the platform’s capabilities and integration with NuVasive’s procedural offerings. 
• 37th Annual Meeting of the Section on Disorders of the Spine and Peripheral Nerves (July 28-31): NuVasive will feature the Pulse platform, X360, and the Simplify Cervical Artificial Disc. The company will participate in a special course titled “Novel and Emerging Technologies in Spine Surgery” with leading spine surgeons on July 28 at 1:30 p.m. PT. This session will discuss the latest technological advances in spine surgery and include a live demonstration of Pulse. 

References
¹ Wang TY, Farber SH, Perkins SS, et al. Internally randomized control trial of radiation exposure using ultra-low radiation imaging versus traditional C-arm fluoroscopy for patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion. Spine 2017;42(4);217-23.
² The Pulse platform can be used in every procedure; however, not all modalities are cleared for every procedure. Refer to Pulse system instructions for use.