July 25, 2018–Englewood, CO – Mighty Oak Medical announced today that its patient-specific, 3D printed FIREFLY® Pedicle Screw Navigation Guides have received an additional FDA 510K clearance for the expanded indications to include S2AI trajectory for sacral-iliac fixation in complex spinal reconstruction surgeries such as scoliosis. The precise mechanical guidance of patient-specific guides is ideal for the S2AI trajectory, since it is a challenging trajectory that crosses the sacral-iliac joint. FIREFLY® Guides, including S2AI, do not require the use of any intraoperative imaging radiation, and are FDA-cleared for use in the adult and pediatric population.
Brent Ness, the Chief Operating Officer at Mighty Oak Medical, stated that “the release of this S2AI Guide has been highly anticipated by our surgeon customers, who look forward to using it to achieve safe and accurate screw placement in a difficult trajectory, reduce OR time, and eliminate the use of intraoperative fluoroscopy, all without the burden of complex and expensive navigation systems.” George Frey, MD, the Chief Medical Officer at Mighty Oak Medical, commented further that “while the S2AI trajectory is a clear improvement over traditional iliac fixation in spinal surgery, it presents significant challenges to the surgeon in placing them safely and accurately. FIREFLY is the most intuitive navigation technology available that eliminates the need for the excessive fluoroscopy typically required to achieve optimal safety and accuracy with the S2AI technique”.
FIREFLY® Pedicle Screw Navigation Guides are a notable exception to the prevailing complexity and expense of current navigation equipment. FIREFLY® does not require an upfront capital expenditure and is single-use and scalable. It features concierge presurgical planning by trained engineers, an autoclavable bone model, predetermined screw sizing, surgeon-approved preselected trajectories, an intraoperative digital plan, and 3D printed patient-specific guides to mechanically constrain the drill and tap to follow the preselected trajectories. FIREFLY® is highly accurate and is designed to increase OR efficiency.
By choice, Mighty Oak does not have its own proprietary screw system, and is actively collaborating with strategic channel partners such as OrthoPediatrics for pediatric facilities in the US. FIREFLY® is open platform and is compatible with all pedicle screw systems.
About Mighty Oak:
Mighty Oak Medical is an independent incubator focused on developing and marketing spinal technologies that improve operating room efficiencies, surgical outcomes, and the overall patient experience, by leveraging the talents of experienced surgeons and biomedical engineers. They are located in Englewood, Colorado. For more information, call 720-398-9703 or send an inquiry to info@mightyoakmedical.com (https://www.mightyoakmedical.com)