NuVasive's LessRay system for reducing exposure to radiation in hospital operating rooms—and particularly keyhole spinal surgery—has been given the go-ahead by the FDA.
The use of minimally invasive spinal procedures has become widespread, raising concern about the radiation exposure to both patient and surgeon, but especially the latter due to the cumulative exposure over their working lives.
NuVasive, which is already a prominent supplier of implants and other components used in spinal surgery, says LessRay is a software and hardware bundle complements designed to enhance the images achieved fluoroscopy—a technique used to image the spine and surrounding areas and guide minimally-invasive surgery (MIS) procedures—with a 62%-84% lower dose of radiation.
Studies show spine and orthopedic surgeons can receive their lifetime occupational radiation limit within the first 10 years of their career, says the company. Surgeons and support staff can use lead aprons and gloves, thyroid shields and protective glasses to try to minimize this, as well as pushing down the radiation dose used, but this can have an impact on image quality, making it grainy and harder to interpret.
From next year, NuVasive plans to start adding additional functionality to the platform, such as neuromonitoring, linking it to its iGA platform for spinal alignment and adding enhanced navigation and imaging features " to address the increasing need for a more systematic approach to spine surgery," according to the firm's CEO Greg Lucier.
The new launch represents a bit of a shift for the company, requiring it to set up a separate sales force to promote the new technology to hospital operating rooms (OR) and provide training in its installation and use. NuVasive says it will plan to sell the system directly to hospitals as well as offer leasing options.
"The launch of LessRay is a significant milestone for NuVasive, as we begin to sell capital equipment and bring technology advancements into the hospital OR," commented Lucier. "We are now executing on our imaging and navigation strategy to improve spine surgery productivity and ultimately predictability."
Analyst Matt O'Brien at Piper Jaffray recently described LessRay as an "under-appreciated growth driver" for the company, addressing a potential market of around $500 million in the US alone that could swell as new features are added. He has predicted $10 million in sales of the system in 2018.