NuVasive Pulse System
NuVasive, IncorporatedThe NuVasive Pulse System is an advanced surgical device designed to assist surgeons during spinal procedures by monitoring neurophysiologic activity and providing enhanced fluoroscopic imaging and navigation. It combines neurophysiologic monitoring to assess nerve function and safety, image enhancement to improve the quality of fluoroscopic images at low doses, and computer-assisted navigation to guide precise placement of spinal implants, helping to improve surgical accuracy and patient outcomes.
Intended Use
The Pulse System is intended for intraoperative neurophysiologic monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremities. It also provides intraoperative image-guided localization for spinal surgical procedures, aiding in precise placement of spinal implants.
Technology
The system includes hardware for nerve stimulation and neurophysiologic signal recording, software for spinal implant localization (Bendini), software for fluoroscopic image enhancement (LessRay) with a video interface, and computer-assisted navigation using an infrared camera to track instruments relative to 2D/3D radiographic images. It supports wireless remote access and integrates multiple predicate technologies.
Performance
Performance testing included tracking accuracy verification, accessory attachment verification, 2D/3D navigation distortion and calibration verification, software validation, cadaver validation for pedicle screw and interbody device placement, and system integration tests. The results demonstrated that the device meets its specifications and shows substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/5/2018
5 months - 2
FDA Approval
6/29/2018
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