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NuVasive receives latest FDA 510(k) clearance for Pulse platform and announces commercial launch

Press releases may be edited for formatting or style | July 30, 2021 Alzheimers/Neurology Operating Room
SAN DIEGO, July 30, 2021 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, announced today that it received its latest U.S. Food and Drug Administration 510(k) clearance for the Pulse® platform, after receiving CE certification earlier this summer. In addition, the company 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 utilization in 100% of spine procedures.1

"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," said J. Christopher Barry, chief executive officer of NuVasive. "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."

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Benefits for patients, surgeons, and hospitals
The availability and integration of multiple applications in Pulse helps surgeons adopt less invasive and more advanced surgical procedures—which provide benefits to the patient, surgeon, and hospital. The benefits of less invasive surgery are supported by extensive clinical evidence, and include:

Reduced operating room (OR) time by up to 60 minutes,2
Savings of nearly $5,000 per patient in hospital costs,3,4
Reduced time under anesthesia and lower intraoperative risks,5 and
Reduced length of stay in the hospital.6
"This first-of-its-kind platform supports all spine procedure types—from open to less invasive techniques. 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," said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. "I want to thank our NuVasive team and the many surgeons who helped bring Pulse to market and enable better spine surgery."

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