Issue link: https://beckershealthcare.uberflip.com/i/1305916
22 DEVICES & IMPLANTS Stryker launches lateral access spine surgery system By Alan Condon S tryker has completed more than 600 surgeries with its Niagara Lateral Access System, which it launched at the North American Spine Society Annual Meeting, taking place virtually Oct. 6-9. Three things to know: 1. Niagara aims to improve surgeon control through precision, visibility and flexibility. 2. The system is intended for all forms of lateral lumbar fusion. 3. Niagara features PEEK-infused carbon fiber with integrated illumination to improve visibili- ty during surgery. This can reduce the number of X-rays required to confirm implant location and placement. n Fluoroscopic glasses demonstrate promise for spine surgery, study finds By Alan Condon A new device that attaches to eyeglasses has been designed to provide fluoroscopic guidance during spine surgery, Medical Xpress reports. The picoLinker device, designed by medical technology company Westunitis, displays real-time fluoroscopic images within the surgeon's visual field. In a study published Oct. 13 in the Journal of Neurosurgery: Spine, Keitaro Matsukawa, MD, PhD, and Yoshiyuki Yato, MD, PhD, of Muraya- ma Medical Center in Tokyo, evaluated the device in patients undergo- ing posterior lumbar interbody fusion at the L5-S1. The same surgeon operated on all 20 patients in the study, performing half the procedures with the device and the other half without it. The picoLinker surgeries resulted in shorter OR times and less radia- tion exposure, according to researchers. One intraoperative complication was noted in the study — a perforated screw that occured when the surgeon was not wearing the device. Researchers found "concentration" and "information centralization" to be the device's two main advantages, improving "ergonomic efficien- cy" by allowing surgeons to focus on operative tasks. n FDA warns stem cell clinic about marketing claims, unapproved uses By Alan Condon A Wisconsin stem cell clinic has been cautioned by the FDA for marketing intrathecal and intravenous injec- tions of human stem cell and tissue-based products for a variety of neurologic condi- tions, according to the Regulatory Affairs Professionals Society. e FDA's Center for Biologics Evaluation and Research on Oct. 1 sent a warning letter to Michael Johnson, DC, a neurologic chiro- practor who runs Optimal Health Stem Cell and Wellness Institute in Appleton, Wis. e letter cited claims on the practice's web- site, Facebook and YouTube channel, which marketed stem cell-based products derived from human adipose tissue, amniotic mem- brane and the umbilical cord. According to the practice's website, condi- tions treated range from Parkinson's disease to multiple sclerosis and traumatic brain in- juries. e FDA has not approved any stem cell products for orthopedic, neurological or cardiovascular conditions yet. One recent Facebook post said, "we use intra- thecal injections into the spine with chronic neurological patients," and claimed that hav- ing "stem cells cross the blood-brain barrier helps the neurological patient to heal faster," according to RAPS. e lawful marketing of these products re- quires a biologics license, which the FDA said the practice does not have. e letter added that "such unapproved uses raise potential significant safety concerns," with the methods used by the practice to ad- minister the products another safety issue due to the "range of adverse events" that can arise from contaminated products injected intra- thecally or intravenously. While there is a lot of hype about the impact of stem cell-based products in neurology and orthopedics, there remains a significant lack of evidence, with many physicians calling for increased regulation and guidance in how these products are marketed. n