Mighty Oak Medical has received CE mark clearance for its patient-specific, 3D-printed FIREFLY pedicle screw navigation system, extending its use into the European market. The technology is already available in Australia and New Zealand, and has been approved for use in the United States by the US Food and Drug Administration (FDA).
Unlike many other navigation systems, FIREFLY does not require an upfront capital expenditure and is single-use and scalable. It features concierge pre-surgical planning by trained engineers, autoclavable bone models, 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 preselected trajectories.
Furthermore, the device has proven to be highly accurate and limit intraoperative radiation exposure. 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 navigation option.
Speaking exclusively to Spinal News International, Heidi Frey, Mighty Oak Medical president, commented on the significance of the CE Mark: “It’s an opportunity for us to expand into other markets where there is clearly a need for this type of navigation solution. We’re already in Australia and New Zealand and are very eager to go to Europe. A number of surgeons there have expressed a high interest in using the technology, so the fact that we can now work with them and others is really exciting.”
Brent Ness, chief operating officer of the company, assessed the benefit of the FIREFLY technology to spine surgeons: “FIREFLY reduces radiation, improves accuracy, and improves efficiency”, all of which contribute to enhanced patient safety. Frey added that the technology is “intuitive and easy-to-use” and so will be a “short learning curve for surgeons”.
Both Frey and Ness emphasise a number of advantages to the FIREFLY technology over its rivals. According to Ness, the prevailing model of navigation is “complex” and typically requires an upfront capital expenditure, which Mighty Oak Medical decided was “counterintuitive”, given the already complex nature of spine surgery. FIREFLY represents a “simplification of the process” and also a more affordable option, owing to the disposable nature of the system.
According to Ness, the need for navigation has been long recognised among surgeons, but many oppose the high costs and complexities of the available technology. Mighty Oak Medical aims to “close the gap between acceptance and adoption” of the procedure with their FIREFLY technology.
On the long-term significance of the technology, Ness added: “There’s no risk of obsolescence. Many other forms of technology are prone to becoming obsolete as the next generation rolls out. You don’t have that risk with 3D printing.”