NuVasive has announced the receipt of the US Food and Drug Administration (FDA) 510(k) approval as well as the commercial launch of its Pulse platform for spine surgeries.
The move follows the receipt of CE mark approval for the latest design update of the platform, which was secured in June.
Pulse is an integrated technology platform designed to increase the safety, efficiency and procedural reproducibility of spine surgery.
It integrates radiation reduction, imaging enhancement, navigation, intraoperative neuromonitoring, patient-specific rod bending, wireless connectivity and spinal alignment tools into a single platform.
This enables surgeons to easily access multiple technologies from a compact footprint as well as address a number of common surgical challenges.
Clinical evidence shows that the Pulse platform has helped surgeons reduce operating room (OR) time, time under anaesthesia, intraoperative risks and length of hospital stays as well as saving hospital costs.
NuVasive CEO Christopher Barry said: “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.”
By integrating multiple enabling technologies, Pulse facilitates less invasive and more advanced surgical procedures that benefit the patient, surgeon and hospital.
NuVasive global business units executive vice-president Massimo Calafiore said: “Pulse is one of the most versatile tools in the spine OR, and the integration of multiple technologies in one platform enhances a surgeon’s capabilities to make better, more informed clinical decisions for their patients.”
Recently, the company commercially launched its Modulus ALIF, a 3D-printed porous titanium implant for anterior lumbar interbody fusion (ALIF), in targeted global regions.