ZKR Orthopedics announces FDA Breakthrough Device designation for the LIFT Implant Technology
KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that its LIFT implant technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The LIFT implant is designed to decrease pain, improve function, and delay or eliminate the need for knee replacement. If granted marketing authorization by the FDA, the LIFT technology will expand the continuum of care for patients suffering from later stage cartilage degeneration and osteoarthritis of the patellofemoral compartment of the knee. Additionally, its design may amplify the efficacy of concomitant procedures, such as cartilage grafting and microfracture, to treat patellofemoral cartilage degeneration.
The LIFT implant elevates and realigns the patella tendon which unloads the patellofemoral compartment by decreasing compressive forces and shifting the patellar tracking towards healthier cartilage. The LIFT system includes trial spacers, a PEEK implant, titanium bone screws, K-wires, and a proprietary positioning instrument. The trial spacers and positioning instrument facilitate optimal implant size selection and positioning under the patella tendon. The implant is temporarily held in place by the K-wires. Permanent fixation is achieved using three standard bone screws. The surgical procedure is designed as a minimally invasive procedure to be performed in an outpatient setting.
Patellofemoral cartilage degeneration is a common condition affecting approximately seven million Americans. The prevalence of this degenerative disease is driven by the common incidence of patella malalignment, as well as demographic factors and the obesity epidemic. A growing body of clinical literature estimates that up to one third of all knee arthritis originates in the patellofemoral compartment. Symptoms include pain, swelling, loss of function, and stiffness. Patients tend to manifest patellofemoral cartilage degeneration symptoms during stair climbing, squatting, sitting and exercise.
Two-year follow up data from the first-in-human trial is expected to be complete in October 2023. These study results will be an important element of the pivotal clinical trial application expected to be submitted to the FDA by year-end. The pivotal trial will be conducted under an FDA Investigational Device Exemption (IDE) and will compare the results of the LIFT implant to results from patients undergoing a tibial tubercle osteotomy. Study enrollment is anticipated to commence in 2024 at multiple sites in the United States and European Union.
The Breakthrough Device Designation underscores the need to expand the continuum of care for patients suffering from cartilage degeneration of the knee. Under the program, ZKR Orthopedics will receive prioritized review and accelerated interaction with the FDA throughout the premarket review phase. To achieve Breakthrough Device designation, ZKR was required to demonstrate that it could provide a more effective treatment for the condition identified in the proposed indications for use.
“We very much appreciate the Breakthrough Device Designation from the FDA. The accelerated regulatory review will likely shorten the time to market allowing expanded options for patients suffering from patellofemoral osteoarthritis. Our hope is to improve both pain and function before the onset of comorbidities associated with a sedentary lifestyle,” stated David Cash, CEO of ZKR Orthopedics.
CONTACT: For more information, contact: ZKR Orthopedics, Inc. info@zkrorthopedics.com
