NuVasive has announced the Pulse surgical automation platform has received 510(k) clearance from the US Food and Drug Administration (FDA). Pulse is the foundation for the company’s Surgical Intelligence system, and introduces 2D- and 3D-navigation and smart imaging capabilities while integrating NuVasive’s neuromonitoring, surgical planning, radiation reduction and patient-specific rod bending technologies.
This single computer platform addresses a broad range of clinical challenges, with enhanced utility and intuitive workflow. The fusion of these technologies supports reproducible spine surgery at facilities ranging from major health systems to ambulatory surgery centres.
“Pulse seamlessly integrates multiple intraoperative technologies through an intuitive guided surgical workflow within a single device and footprint in the operating room,” says Stephen Ryu (Palo Alto Medical Foundation, Palo Alto, USA). “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.”
Pulse’s FDA clearance marks a major milestone in the company’s 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, a press release states. The Pulse platform provides an intuitive surgeon experience by anticipating user needs and fusing these technologies to create a seamless, optimised workflow for operating rooms (OR). Through Wi-Fi connectivity and independent device access, case participants can simultaneously view the technologies’ imaging and insights in real time, allowing them to utilise various modules in parallel and further drive OR efficiencies.
“With Pulse, our strategy is to integrate technology to ultimately drive better spinal procedures and meet the unique needs of each OR through customised applications,” comments Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “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.”
To help surgeons overcome frequent visualisation challenges during spine surgery, Pulse integrates multiple high-resolution cameras combined with low-profile, 360-degree arrays to drive uninterrupted line-of-sight and optimised procedural workflow. Additionally, Pulse introduces advanced artificial intelligence (AI) by automating several technologies utilized throughout a procedure.
NuVasive will showcase the Pulse platform at the North American Spine Society 2018 Annual Meeting (NASS; 26–29 September, Los Angeles, USA).