NuVasive has announced that it has received US Food and Drug Administration 510(k) clearance for its Pulse platform, after receiving CE mark certification earlier this summer. In addition, the company has announced the commercial launch of Pulse which is now available for sale in targeted global regions.
Pulse is an integrated technology platform designed to increase safety, efficiency, and procedural reproducibility of spine surgery. The platform allows surgeons to easily access multiple technologies from a condensed footprint and address some of the most common surgical challenges. It is currently the only enabling technology platform with the ability for utilisation in 100% of spine procedures, say NuVasive.
J. Christopher Barry, chief executive officer of NuVasive, said: “The Pulse platform launch is an incredible milestone for NuVasive and will help lead the digital transformation of spine surgery. Surgeons are now able to seamlessly work with various technologies to address more clinical challenges in surgery from a single platform—something they could not do before Pulse.
“This is the culmination of years of research and development to deliver a platform that helps improve clinical, financial, and operational outcomes. Like we did with XLIF, Pulse is a disruptive technology that has the ability to transform not only the trajectory of NuVasive but the future of spine care for patients.”