ZKR Orthopedics, a clinical-stage medical device company, has made a significant announcement regarding the FDA's Breakthrough Device Designation for its pioneering LIFT implant technology. This development marks a substantial milestone for the company as the LIFT implant is poised to revolutionize the treatment of knee-related issues, offering potential relief from pain, enhanced functionality, and even the potential to obviate the need for knee replacement surgeries.
The LIFT technology has the potential to redefine the continuum of care for patients grappling with advanced cartilage degeneration and osteoarthritis affecting the patellofemoral compartment of the knee. Additionally, its adaptability to complement other procedures such as cartilage grafting and microfracture for patellofemoral cartilage degeneration could be a game-changer in the field.
The LIFT implant functions by elevating and realigning the patella tendon, effectively reducing compressive forces on the patellofemoral compartment and promoting a healthier patellar tracking. The LIFT system is comprehensive, comprising trial spacers, a PEEK implant, titanium bone screws, K-wires, and a proprietary positioning instrument. The trial spacers and positioning tool are invaluable in selecting the optimal implant size and positioning under the patella tendon, with K-wires temporarily securing the implant in place. Permanent fixation is achieved with the use of three standard bone screws, and the surgical procedure is designed to be minimally invasive and suitable for outpatient settings.
The prevalence of knee cartilage degeneration is fueled by factors like common patella misalignment, demographic considerations, and the increasing incidence of obesity. A substantial body of clinical research indicates that up to one-third of knee arthritis cases have their origin in the patellofemoral compartment, leading to distressing symptoms such as pain, swelling, diminished function, and stiffness.
A pivotal trial for this innovative technology will be conducted under an FDA Investigational Device Exemption (IDE) and will compare outcomes with patients receiving the LIFT implant to those undergoing tibial tubercle osteotomies. The FDA's decision to grant Breakthrough Device Designation underscores the pressing need for expanded care options for patients with knee cartilage degeneration. ZKR Orthopedics, as part of this program, will receive prioritized reviews and expedited interactions with the FDA during the premarket review phase.