NuVasive Receives Latest FDA Clearance for Pulse Platform and Announces Commercial Launch

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NuVasive, Inc., the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, announced that it received its latest U.S. FDA 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% 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, chief executive officer 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.”

Benefits for patients, surgeons, and hospitals
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 alerts[9] 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.

Learn more about Pulse
To learn more about the Pulse platform, visit NuVasive on our website or at upcoming industry events:

  • NuVasive’s first virtual Innovation Event—click to watch
  • 37th Annual Meeting of the Section on Disorders of the Spine and Peripheral Nerves (July 28-31)
  • 2021 American Association of Neurological Surgeons Annual Scientific Meeting (August 21-25)
  • Scoliosis Research Society 56th Annual Meeting (September 22-25)

About NuVasive
NuVasive, Inc. is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company’s less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company’s comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients.