Second FDA clearance for patient-specific 3D printed Firefly pedicle screw navigation guides

Mighty Oak Medical's Firefly
Mighty Oak Medical’s Firefly

Mighty Oak Medical has received a second FDA clearance for its patient-specific, 3D-printed Firefly pedicle screw navigation, extending compatibility to essentially all currently cleared pedicle screw systems. A press release reports that the new clearance also extends the indications for use to T1–S2/ilium. It adds that by choice, Mighty Oak does not have its own proprietary screw system and is actively collaborating with strategic channel partners.

According to the press release, Firefly pedicle screw navigation guides are a notable exception to the prevailing complexity and expense of current navigation equipment. The Firefly technology platform has already received two spine technology awards for its 3D printed patient-specific solutions to challenges in spinal surgery, including the one it received last week.

Firefly does not require an upfront capital expenditure and is single-use and scalable. It features concierge pre-surgical planning by trained engineers, an autoclavable bone model, predetermined screw sizing, surgeon-approved preselected trajectories, an intraoperative plan, and 3D printed patient-specific guides to mechanically constrain the drill and tap to follow the preselected trajectories. Also, the device is designed to be highly accurate and limit intraoperative radiation exposure. In 10 of 14 recent Firefly surgeries, no fluoroscopy was used for drilling, tapping or pedicle screw placement. The system does not disrupt surgical flow and is designed to increase operating room efficiency. It is also the only patient-specific pedicle screw guide indicated for use in paediatric patients.

Firefly technology should also be able to help hospitals faced with scheduling conflicts for their current navigation systems. By being open platform and compatible with essentially all currently cleared pedicle screw systems, these patented 3D printed patient-specific guides are an exciting new option on the navigation menu.

Brent Ness, the chief operating officer for Mighty Oak and former vice president of Global Sales and Marketing  for Medtronic Navigation, says: “Firefly technology is at the epicentre of three strong trends: 3D printing, personalised medicine, and pre-surgical planning. It is uniquely situated to bring navigation to standard of care around the world.”