CASPER, Wyo., Feb. 2, 2021 /PRNewswire/ — McGinley Orthopedics, the developer of the patented Lever Action Plate System®, partnered with hand surgeons at Shriners Hospitals for Children – Philadelphia to implant the first plate this week. The system is a dynamic, fragment reduction technology that assists surgeons in restoring volar tilt and articular congruity. This technology allows surgeons to easily align complex wrist fractures with a twist of a dial. Dr. Dan Zlotolow first identified the issue in surgeries for distal radius fractures with his own patients and set out to find a better solution. Dr. Zlotolow, worked with the engineering team at McGinley Orthopedics to develop the system that received FDA clearance in June 2020. McGinley Orthopedics holds multiple patents on the system due to the unique design and functional capabilities. This past week, Dr. Zlotolow was the first surgeon to implant the plate in a patient. The surgery was a great success, and he is proud to report that this young snowboarder is now reaping the benefits of this innovative technology. “The ability to dial in the volar tilt is a game changer.” A novel solution for a wide range of distal radius fractures, The Lever Action Plate System® provides precise, plate-assisted reduction of fractures.
The Lever Action Plate System® improves the standard of care by offering the first functional plate on the market. Current techniques are imprecise, leaving frustrated surgeons to accept less than anatomic alignments, which leads to traumatic arthritis. Failure to restore an alignment also risks placement of screws in unsatisfactory positions, including within the wrist joint. In some cases, the patient may need a repeat surgery to revise the alignment and replace the conventional plate, further increasing the chances of stiffness and/ or traumatic arthritis. The Lever Action Plate System® gives surgeons the ability to precisely adjust the alignment of the broken bone fragments, limiting the need for further surgery and the risk of complications.
Why this innovative technology is critical for patients?
The Lever Action Plate System® addresses a real and prevalent need in orthopedics. Distal radius fractures account for about 20% of all fractures. 1 in 5 ER treated fractures are of the distal radius. A complication rate of 15% has been reported with traditional volar plating. The Lever Action Plate System® is an improvement on the standard of care. The system is patented, FDA cleared and available for use.
Details for surgeons and industry leaders:
The innovative Lever Action Plate System® features proprietary subchondral beams that dynamically align volar tilt. The beams are used to elevate the malreduced fracture fragments with the turn of a screw to the surgeon’s desired position. Optimizing alignment, the beams provide independent fixation of the central and radial column. The beam’s contoured design provides subchondral fixation to reduce subsidence. When standard reduction techniques prove inadequate, the plate itself can be used as a controlled, dynamic reduction tool by the addition of one or two subchondral beams. These beams can be used to elevate the lunate and scaphoid facets independently or together, allowing not only reliable restoration of anatomic volar tilt, but also reduction of die-punch, sagittal, and coronal split fractures in situ.
An improvement on the current plates available on the market, the system also has optional variable angle screws of varying sizes with patented locking technology. The plate is contoured to sit just proximal to the watershed line on the distal radius. The Lever Action Plate System® is designed to assist the surgeon with restoring volar tilt and intra-articular fracture alignment, facilitating an anatomic reduction and potentially improving patient outcomes. Used in combination with the IntelliSense Drill Technology®, a drill that auto-stops at the far cortex of the bone and indicates depth measurement for accurate screw sizing, the Lever Action Plate System® will improve outcomes and minimize risk.
Surgeons and industry leaders can see the Lever Action Plate System® at the 2021 annual meeting of the American Academy of Orthopedic Surgeons (AAOS) and the American Society for Surgery of the Hand (ASSH).
SOURCE McGinley Orthopedics