NuVasive Pulse System
Globus Medical, IncThe NuVasive Pulse System is a medical device that helps surgeons precisely locate anatomical structures during spinal surgeries using intraoperative 3D imaging and computer-assisted navigation. It tracks surgical instruments in real-time and overlays their virtual positions on patient images, enhancing surgical accuracy and safety in procedures like pedicle screw placement and iliosacral screw placement.
Intended Use
Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. It enables computer-assisted navigation by virtually displaying tracked instruments and implants on a patient's 3D radiographic image data derived from CT or Cone Beam CT scans.
Technology
The device comprises hardware and software including fiducial-based registration using patient reference hardware (Pulse ICT Adapter and ExcelsiusGPS ICT Fixture) to provide a rigid anatomical reference. It employs an infrared camera to track instruments in 3D space, which are superimposed on CT/Cone Beam CT images for navigation. The system components include Pulse NVM5 for nerve monitoring, Pulse LessRay for fluoroscopic image enhancement, and Pulse Navigation software for stereotactic surgical localization.
Performance
Nonclinical system, software, and instrument verification and validation testing were performed demonstrating compliance with design inputs and user needs. Testing included qualitative validation confirming intended use, usability engineering standards, and positional accuracy standards according to ASTM and IEC guidelines. These tests showed system performance meeting requirements and substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/11/2024
1 month - 2
FDA Approval
1/10/2025
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.