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FDA OKs NuVasive's Pulse Platform

FDA OKs NuVasive's Pulse Platform

First-of-its-kind platform integrates multiple technologies to address most common spine surgery clinical challenges.

By NuVasive07.30.21
NuVasive Inc. received its latest U.S. Food and Drug Administration 510(k) clearance for the Pulse platform, after receiving CE certification earlier this summer. In addition, the company announced the commercial launch of Pulse which is now available for sale in targeted global regions.
 
Pulse is an integrated technology platform designed to increase safety, efficiency, and procedural reproducibility of spine surgery. The platform allows surgeons to easily access multiple technologies from a condensed footprint and address some of the most common surgical challenges. It is currently the only enabling technology platform with the ability for utilization in 100 percent of spine procedures.1
 
“The Pulse platform launch is an incredible milestone for NuVasive and will help lead the digital transformation of spine surgery. Surgeons are now able to seamlessly work with various technologies to address more clinical challenges in surgery from a single platform—something they could not do before Pulse,” said J. Christopher Barry, CEO of NuVasive. “This is the culmination of years of research and development to deliver a platform that helps improve clinical, financial, and operational outcomes. Like we did with XLIF, Pulse is a disruptive technology that has the ability to transform not only the trajectory of NuVasive but the future of spine care for patients.”
 
The availability and integration of multiple applications in Pulse helps surgeons adopt less invasive and more advanced surgical procedures—which provide benefits to the patient, surgeon, and hospital. The benefits of less invasive surgery are supported by extensive clinical evidence, and include:
 
  • Reduced operating room (OR) time by up to 60 minutes,2
  • Savings of nearly $5,000 per patient in hospital costs,3,4
  • Reduced time under anesthesia and lower intraoperative risks,5 and
  • Reduced length of stay in the hospital.6
 
“This first-of-its-kind platform supports all spine procedure types—from open to less invasive techniques. Pulse is one of the most versatile tools in the spine OR, and the integration of multiple technologies in one platform enhances a surgeon’s capabilities to make better, more informed clinical decisions for their patients,” said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. “I want to thank our NuVasive team and the many surgeons who helped bring Pulse to market and enable better spine surgery.”
 
An Integrated Technology Platform to Enable Better Spine Surgery
Pulse integrates multiple technologies into one platform, and its extensible architecture can support future applications, including robotics and smart tools.7 Currently, the platform includes:
 
  • Radiation reduction and imaging enhancement: NuVasive’s Lessray technology was designed to increase OR efficiency through streamlined imaging workflow, while also significantly reducing exposure to radiation for everyone in the room.8 Pulse supports numerous imaging systems, but offers enhanced integration with Siemens’ cutting-edge 3D mobile C-arm—the Cios Spin.
  • Navigation: Pulse introduces a procedurally integrated navigation technology that offers the potential to improve screw placement accuracy and minimize radiation.
  • Neuromonitoring: This application provides proprietary automated nerve detection with standardized setup and clinically validated alerts9 to help reduce variability and allow for faster interpretation of neural information.
  • Global alignment: NuVasive’s Integrated Global Alignment (iGA) technology offers surgical planning and intraoperative assessment tools to help surgeons correct or restore spinal alignment. Surgeons can later follow up postoperatively to assess the results of the procedure.
  • Patient-specific rod bending: NuVasive’s spinal rod bending technology, Bendini, is used to create patient-specific rods that are bent to implant locations. Bendini expedites manual rod manipulation through computer-assisted bend instructions.
  • Wireless connectivity: This tool allows seamless connectivity and control of the Pulse platform from all members of the surgical team in the OR—from the surgeon to the C-arm technologist to support staff.
 
References
1 The Pulse platform can be used in every spine procedure; however, not all modalities are cleared for every spine procedure. Refer to Pulse system instructions for use.
2 Macario A. What does one minute of operating room time cost? J Clin Anesth 2010;22(4):233-6.
3 Shippert RD. A study of time-dependent operating room fees and how to save $100,000 by using time-saving products. Am J Cosmet Surg 2005;22(1):25-34.
4 Olsen MA, Mayfield J, Lauryssen C, et al. Risk factors for surgical site infection in spinal surgery. J Neurosurg 2003;98(2):149-55.24.
5 Olsen MA, Nepple JJ, Riew KD, et al. Risk factors for surgical site infection following orthopaedic spinal operations. J Bone Joint Surg Am 2008;90(1):62-9.
6 Lucio JC, VanConia RB, DeLuzio KJ, et al. Economics of less invasive spinal surgery: an analysis of hospital cost differences between open and minimally invasive instrumented spinal fusion procedures during the perioperative period. Risk Manag Healthc Policy 2012;5:65-74.
7 Robotics and smart tools are not cleared for use by the FDA.
8 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.
9 Tohmeh AG, Rodgers WB, Peterson MD. Dynamically evoked, discrete-threshold electromyography in the extreme lateral interbody fusion approach. J Neurosurg Spine 2011;14(1):31-7.
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