NuVasive, a medical device company focused on transforming spine surgery, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Pulse surgical automation platform.
The Pulse platform, which is the foundation for NuVasive’s Surgical Intelligence ecosystem enabling better surgery, addresses spine technology and clinicaneeds across all spine procedures.
Pulse introduces 2D- and 3D-navigation as well as smart imaging capabilities and integrates the company’s neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies.
The single computer platform addresses an array of clinical challenges, with improved utility and better workflow.
NuVasive said fusion of these technologies can support reproducible spine surgery at facilities that range from major health systems to ambulatory surgery centers.
California-based Palo Alto Medical Foundation neurosurgeon Stephen Ryu said: “Pulse seamlessly integrates multiple intraoperative technologies through an intuitive guided surgical workflow within a single device and footprint in the operating room.
“Unlike other newer surgical technologies, Pulse enhances the surgeon’s ability and can positively affect outcomes by providing a modular platform of useful intraoperative tools that do not disrupt familiar workflow. Additionally, Pulse provides enhanced support throughout each case be it a simple decompression all the way to complex deformity cases.”
NuVasive said the FDA clearance of Pulse marks a milestone for its commitment to introduce 2D and 3D navigation technology built on a platform of the Company’s NVM5 nerve monitoring system, LessRay, Bendini and Integrated Global Alignment (iGA) systems.
The Pulse platform predicts user requirements and the technologies fusion will create an optimized workflow for operating rooms (OR).
With Wi-Fi connectivity and independent device access, case participants can simultaneously see the technologies’ imaging and insights in real time.
It will enable them to use several modules in parallel and further drive OR efficiencies.
The company also stated that the Pulse integrates multiple high-resolution cameras combined with low-profile, 360-degree arrays for an uninterrupted line-of-sight and optimized procedural workflow. This will help surgeons overcome the visualization challenges during spine surgery.
NuVasive strategy, technology and corporate development executive vice president Matt Link said: “With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customized applications.
“Through the aggregation of clinical data and intelligent design, Pulse intuitively delivers the necessary technological intervention to drive improvements in procedural workflow and support the clinical needs for each OR, surgeon and case.”