Here are eight things for spinal surgeons to know for May 4, 2017.
Medtronic to revise spine device indications after 2 deaths
Medtronic notified the FDA of two patient deaths following spine surgeries where the surgeon used its NavLock Tracker as part of the procedure. In the two patient death cases, surgeons used third-party surgical stereotaxic navigation instruments that the FDA has not cleared for use with the NavLock Tracker. In response to the patient deaths and other injuries, Medtronic is updating NavLock's product labeling, clarifying the indications for using non-Medtronic instruments with the product.
Do overlapping neurosurgeries have worse outcomes?
A new Phoenix-based study examines whether overlapping neurosurgeries yield different outcomes compared to non-overlapping procedures. Patients who underwent overlapping surgeries reported significant benefit in outcomes measures including length of stay, return to the operating room and disposition status. The procedure length was the only measured outcome with significant differences; the overlapping cases were longer and more senior residents staffed them. Researchers found the outcomes weren't worse among surgeons who performed overlapping procedures; in several cases, the outcomes were actually better.
Johnson & Johnson, US Defense Dept. reach $260.5M deal on orthopedic devices
Johnson & Johnson and the U.S. Defense Department entered a $260.5 million deal for orthopedic devices. J&J will supply the Army, Navy, Air Force, Marine Corps and federal civilian agencies with orthopedic products. The one-year contract includes four additional one-year options.
1st-ever dual robotic surgery performed in Israel
Surgeons at Jerusalem, Israel-based Hadassah Hospital Ein Kerem used Siemens' Artis Zeego and Mazor Robotics' Renaissance Guidance System to perform spine surgery. The surgery represented the first time surgeons used the two robotic technologies in tandem for spine surgery. Surgeons performed the three-hour procedure on April 23 to repair a patient's severe spinal fracture.
Zimmer Biomet CEO addresses implant production slowdown amid tripling Q1 earnings
Despite huge profits in 2016 for Zimmer Biomet, the company experienced a production slowdown as it worked on quality and manufacturing systems issues related to integrating Biomet after acquiring the company in 2015. Zimmer Biomet reported first quarter earnings at $299 million, nearly tripling earnings from the first quarter last year, despite production slowing. But CEO David Dvorak is not deterred and remains optimistic about the company's future. Read his thoughts here.
Aurora Spine reports 2016 revenue of $6.8M
Aurora Spine reported financial results for the 2016 fiscal year, citing revenue of $6.76 million. In 2016, Aurora Spine's net loss decreased to $1.7 million, or $0.05 per share, compared to $2.9 million in 2015. U.S. sales accounted for about 96 percent of the company's revenue in 2016.
SI-BONE iFuse patients 11x less likely to take opioids compared to non-surgical patients
SI-BONE reported results studies revealing the iFuse Implant System's impact on opioid use. A six-year study, published in Neurosurgery, found iFuse patients were 11 times less likely to take opioids at the last follow-up, than those patients who received either conservative care or radiofrequency ablation.
North American vertebroplasty market to fall from $72M in 2016 to $29.4M by 2023
The North American vertebroplasty market will likely witness a 12 percent negative compound annual growth rate through 2023, according to a GlobalData analysis. The market is set to drop from $72 million in 2016 to $29.4 million by 2023. Analysts noted procedure adoption is inconsistent because of sparse data demonstrating vertebroplasty's efficacy. The risk of cement leakage and damage to the surrounding spinal canal and nerves deters wide adoption of the procedure.