NuVasive receives 510(k) clearance for integrated technology platform for spine surgery
The FDA granted 510(k) clearance to NuVasive Inc. for Pulse, an integrated technology platform designed to increase the safety and efficacy of spine surgery, according to a press release.
According to the release, the Pulse platform is “currently the only enabling technology platform with the ability for utilization in 100% of spine procedures” and can help surgeons adopt less invasive procedures, which can result in reduced hospital costs, operation time and length of hospital stay.
“This first-of-its-kind platform supports all spine procedure types — from open to less invasive techniques,” Massimo Calafiore, executive vice president of global business units at NuVasive, said in the release. “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."
According to the company, integration of multiple technologies by the platform will allow it to support applications such as smart tools and robotics. The program gained CE certification in June.
“This is the culmination of years of research and development to deliver a platform that helps improve clinical, financial, and operational outcomes,” J. Christopher Barry, the CEO of NuVasive, said. “Like we did with [extreme lateral interbody fusion], 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.”
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