NuVasive Pulse System

by NuVasive  · Based in United States → — The first integrated technology platform to enable better spine surgery.
Neurosurgery Orthopedics
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Regulatory Status Disclosed

Overview

The NuVasive Pulse System is an integrated technology platform meticulously designed to enhance the safety, efficiency, and reproducibility of a comprehensive range of spine surgical procedures. This innovative system consolidates multiple advanced technologies into a single, modular platform, effectively addressing prevalent clinical challenges such as minimizing radiation exposure, preventing nerve and spinal cord injury, and managing spinal deformity.

Its extensible architecture not only supports current applications but is also engineered to seamlessly integrate future technological advancements, including robotics and smart tools. By providing surgeons with real-time insights and automating critical functions, Pulse aims to optimize surgical workflow, significantly reduce variability, and improve patient outcomes. These benefits include a reduction in operating room (OR) time, shorter hospital stays, and lower intraoperative risks, ultimately transforming the standard of spine care.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Integrated 2D and 3D Navigation for precise anatomical targeting and screw placement accuracy
  • Intraoperative Neuromonitoring (NVM5) with automated nerve detection and validated alerts
  • Surgical Planning with Integrated Global Alignment (iGAu00ae) for preoperative planning and real-time intraoperative assessment
  • Radiation Reduction (LessRayu00ae) technology to enhance imaging and significantly reduce radiation exposure
  • Patient-Specific Rod Bending (Bendiniu00ae) with computer-assisted instructions for customized spinal rods
  • Smart Imaging Capabilities, including enhanced integration with Siemens Healthineers' Cios Spinu00ae 3D mobile C-arm
  • Advanced Artificial Intelligence (AI) for automating several technologies and improving workflow
  • Modular and Extensible Architecture allowing for flexible technology packages and future upgrades like robotics
  • Wireless Connectivity for seamless information access and task execution within the operating room

Use Cases

  • All types of spine surgical procedures
  • Minimally invasive spine surgery (MIS)
  • Complex deformity correction surgeries
  • Pedicle screw placement
  • Interbody device placement
  • Iliosacral screw placement

What Physicians Need to Know

Surgical Planning Capabilities
Features Integrated Global Alignment (iGAu00ae) software for comprehensive pre-operative planning, incorporating alignment parameters, implant integration, and surgical modeling. It also allows for intraoperative assessment of spinal alignment with real-time insights.
Intraoperative Guidance
Provides 2D and 3D imaging and navigation, automated neuromonitoring for nerve detection with validated alerts, and Smart Imaging with LessRayu00ae for radiation reduction (up to 80% compared to standard fluoroscopy). It also includes Bendiniu00ae for patient-specific spinal rod bending and on-the-fly trajectory planning.
3D Reconstruction Quality
Leverages Siemens Healthineers' Cios Spin 3D mobile C-arm for cutting-edge intraoperative 3D imaging. The Cios Spin features CMOS flat detector technology, 30-second scan speed, simultaneous three projection display, and metal artifact reduction (MAR) for high-quality 3D images.
Robotic Surgery Integration
Designed with an extensible architecture capable of integrating future applications, including a dedicated spine robotics module, which NuVasive has demonstrated.
Surgical Navigation Accuracy
Demonstrated superior accuracy for pedicle screw placement, with significantly lower screw breach rates (9%) compared to free-hand fluoroscopy (18%) in cadaveric studies. Initial testing indicates lower navigation accuracy error rates than other systems on the market.
Pre-Operative Assessment
Utilizes Integrated Global Alignment (iGAu00ae) for pre-operative planning, enabling surgeons to establish alignment parameters, integrate implants, and perform surgical modeling to create a reliable surgical plan.
Post-Operative Monitoring
iGAu00ae technology allows for follow-up to evaluate procedure outcomes and intraoperative assessment of spinopelvic alignment using image stitching to confirm the preoperative plan was achieved.
Operating Room Workflow Integration
Engineered for an intuitive and seamless OR workflow, integrating multiple technologies into a single platform with a condensed footprint. It supports independent device access and wireless connectivity, allowing staff to simultaneously view imaging and insights, which can reduce OR time by up to 60 minutes.
Physician Tip

Leverage the integrated iGAu00ae for comprehensive pre-operative planning and real-time intraoperative alignment assessment. Utilize LessRayu00ae technology to significantly reduce radiation exposure for both patients and the surgical team. Rely on the automated neuromonitoring system for real-time nerve detection and validated alerts to enhance patient safety. Confirm navigation accuracy repeatedly throughout the procedure, especially after initial registration and before working on each level, by comparing the navigated instrument tip to anatomical landmarks. Take advantage of the Bendiniu00ae system for precise, patient-specific rod bending within the OR to improve efficiency and implant fit. Optimize OR setup for efficiency, especially for procedures like Lateral Single-position Surgery (LSPS), to maximize time savings and reduce patient repositioning risks.

The Pulse system is designed with a modular and open architecture, allowing for flexible technology packages and the integration of future applications, including robotics. It has a strategic partnership with Siemens Healthineers, leveraging the Cios Spin 3D mobile C-arm for advanced intraoperative 2D and 3D imaging and navigation. The platform integrates various NuVasive technologies such as neuromonitoring (NVM5u00ae), surgical planning (iGAu00ae), radiation reduction (LessRayu00ae), and patient-specific rod bending (Bendiniu00ae). Wireless connectivity enables seamless access and management of the platform by all surgical team members, promoting coordinated workflow. The system is compatible with NuVasive's Reline and VuePoint fixation screws for navigation.

Details

Category Surgical AI
Pricing Contact for pricing — Pricing is not publicly available; contact sales for a detailed quotation.
DeploymentOn-premise (integrated into surgical suite)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The NuVasive Pulse System received initial 510(k) clearance from the U.S. FDA on June 29, 2018 (K180038) and a later 510(k) clearance on July 29, 2021 (K210574). These clearances cover its integrated platform, including neuromonitoring, LessRay, and navigation components for use in spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities.
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics

Ratings & Reviews

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Press & Coverage

PR Newswire
NuVasive Receives Latest FDA 510(k) Clearance for Pulse Platform and Announces Commercial Launch
NuVasive announced it received its latest U.S. FDA 510(k) clearance for the Pulse platform and commercially launched the system, which is designed to increase safety, efficiency, and reproducibility of spine surgery. The platform integrates multiple technologies like radiation reduction, imaging enhancement, navigation, neuromonitoring, global alignment, and patient-specific rod bending.
2021-07
PR Newswire
NuVasive Launches Pulseu2122u2014The First Integrated Technology Platform to Enable Better Spine Surgery
NuVasive launched the Pulse integrated technology platform, the first single platform to combine multiple technologies for more efficient, less disruptive spine surgery. The system aims to improve workflow, reduce variability, and increase surgical reproducibility across all spine procedures.
2019-07
Becker's Spine Review
What's next for NuVasive's Pulse platform? - Becker's Spine Review
NuVasive's Pulse integrated spine surgery system launched commercially in summer 2021, with initial cases in Ohio and Texas. The platform is designed to improve safety and efficiency, offering a seamless workflow and the ability to add future surgical applications.
2022-02
Medical Device Network
NuVasive's Pulse Platform for Spine Surgeries, US - Medical Device Network
The Pulseu2122 system, developed by NuVasive, is the first integrated technology platform aimed at improving the safety, efficiency, and reproducibility of all spine surgical procedures. It received 510(k) clearance from the US FDA in July 2021 and CE Mark approval in June 2021.
2021-08
ODT Magazine
FDA OKs NuVasive's Pulse Platform - ODT Magazine
NuVasive Inc. received FDA 510(k) clearance for its Pulse platform after obtaining CE certification, and subsequently launched the product commercially. The platform is designed to increase safety, efficiency, and procedural reproducibility in spine surgery by allowing surgeons to access multiple technologies from a condensed footprint.
2021-07
PR Newswire
NuVasive Receives Latest CE Mark Approval for Pulse Platform and Starts Global Clinical Evaluations - PR Newswire
NuVasive announced that its Pulse platform received CE Mark approval for its latest design update, with clinical evaluations commencing in Europe. This approval is a key commercialization milestone for an expanded global launch.
2021-06
FierceBiotech
NuVasive nabs FDA clearance amid global rollout of all-in-one spine surgery platform
NuVasive received FDA clearance for its Pulse spine surgery platform, coinciding with its global rollout following a CE mark in June. The platform integrates various tools and technologies to streamline all types of spinal surgery.
2021-07
NuVasive, Inc. (Peer-Reviewed Study)
An Evaluation of the Accuracy, Efficiency, and Safety of Pulseu00ae Navigation Percutaneous Pedicle Screw Placement: A Randomized, Cadaveric Study - NuVasive, Inc.
A randomized cadaveric study evaluated the accuracy, efficiency, and radiation safety of NuVasive Pulse navigation compared to traditional free-hand fluoroscopy for pedicle screw placement. The study concluded that Pulse navigation demonstrated superior accuracy, improved screw placement efficiency, and lower radiation exposure.
unknown

Videos

Product demos, reviews, and walkthroughs for NuVasive Pulse System.

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Frequently Asked Questions

The NuVasive Pulse System integrates advanced AI to automate several intraoperative technologies, including neuromonitoring, surgical planning, and patient-specific rod bending (Bendini). It also features smart imaging with LessRay for radiation reduction and 2D/3D navigation to improve screw placement accuracy and assess spinal alignment via Integrated Global Alignment (iGA).
The NuVasive Pulse System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in July 2018 and July 2021, and CE Mark approval in June 2021. This clearance signifies that the system, comprising Pulse NVM5, Pulse LessRay, and Pulse Navigation, is deemed safe and effective for its intended use as an intraoperative image-guided localization system in spinal surgical procedures.
While established navigation systems like Medtronic Stealth and BrainLab are widely used, the NuVasive Pulse System differentiates itself by integrating multiple surgical assistance technologies into a single platform, including AI-driven automation for workflow. Other novel systems like 7D Surgical and Augmedics XVision, or robotic platforms such as Medtronic MazorX and Globus ExcelsiusGPS, also offer advanced features, often combining navigation with robotic assistance for precise trajectory alignment.
The NuVasive Pulse System itself typically costs between $365,000 and $505,000, depending on the configuration and specific modules included. This cost generally covers the integrated platform, though additional NuVasive instrumentation or specific accessories, such as EMG needle modules, may be priced separately.
The NuVasive Pulse System's 3D integration is currently optimized for use with the Siemens CIOS Spin C-arm, and the system is generally optimized for NuVasive instrumentation. It is contraindicated in cases where radiographic images are insufficient to accurately localize instruments or implants relative to patient anatomy. Additionally, the LessRay component's use with devices other than a fluoroscopic X-ray or C-arm has not been evaluated.
As a medical device with FDA 510(k) clearance, the NuVasive Pulse System is designed to comply with relevant healthcare data security and privacy regulations. While specific details on its data encryption or storage protocols were not explicitly detailed in the provided information, its regulatory approval implies adherence to standards for protecting patient information within its operational scope.
The Pulse system supports numerous imaging systems and offers enhanced integration with Siemens' Cios Spin 3D mobile C-arm. While the platform is designed for an intuitive workflow and independent device access for staff to view imaging and insights, the extent of its direct integration capabilities with various existing hospital EHR systems would typically depend on specific hospital IT infrastructure and vendor agreements.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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