In an approach very much the opposite of the usual tech world recommendation to “move fast and break things,” years after scoring the first regulatory approvals for its Pulse technology, NuVasive is finally preparing to roll out the spine surgery support platform.
That rollout will begin in Europe, now that the San Diego-based company has received a CE mark for the updates it has made to its Pulse platform in recent years. The launch is slated for “later this summer,” Massimo Calafiore, NuVasive’s executive vice president of global business units, said in a statement.
With that green light under its belt, NuVasive also confirmed that it has begun clinical evaluations in several European countries ahead of the platform’s commercial launch on the continent.
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While preparing for the Pulse platform’s European debut, NuVasive will also be awaiting regulatory approval on this side of the Atlantic. The technology was initially cleared by the FDA in 2018, but the company opted to hold off on its U.S. rollout at the time, in favor of adding additional capabilities to the system and then testing those upgrades.
Those additions and evaluations were completed within the last year, and NuVasive CEO Chris Barry reported in a May 5 earnings call that the company had recently submitted its application for an updated 510(k) clearance for the platform.
NuVasive expects to receive the FDA’s blessing sometime this summer, allowing it to begin a small clinical rollout shortly after, followed by a broader commercial launch later in the year, Barry said.
The Pulse platform is designed to serve as something of a one-stop shop in the operating room to support spine surgeries from start to finish.
It combines navigation and robotics capabilities for spine operations, as well as equipment to reduce OR teams’ radiation exposure, such as technology to enhance low-dose fluoroscopic images up to higher qualities.
The platform’s Bendini system, meanwhile, guides surgeons through the process of bending spinal rods to fit patients’ specific needs, a finicky process that can take multiple attempts when done manually.
In addition, Pulse features neuromonitoring capabilities that automatically send alerts when potential nerve damage is detected during a procedure. The platform also helps OR staff analyze 3D imaging data, navigate through an operation and monitor nerve function on monitors as well as connected laptops and tablets.
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The entire system is modular, allowing facilities to add and take away Pulse’s laundry list of technologies as needed. It also integrates with a variety of imaging devices, though its specially designed to work with Siemens Healthineers’ Cios Spin, a mobile C-arm providing 3D X-ray images.
According to NuVasive, all of these independent features allow its Pulse platform to be used in some fashion across 100% of spine surgery procedures.