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ZKR Orthopedics’ LIFT implant technology has been granted Breakthrough Device Designation by 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 FDA, LIFT will expand the continuum of care for patients with 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. LIFT 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.
Two-year follow-up data from the first-in-human trial is expected to be complete this month. 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 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 US and EU.
“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.
Source: ZKR Orthopedics
ZKR Orthopedics’ LIFT implant technology has been granted Breakthrough Device Designation by 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 FDA, LIFT will expand the continuum of care for patients with later-stage cartilage...
ZKR Orthopedics’ LIFT implant technology has been granted Breakthrough Device Designation by 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 FDA, LIFT will expand the continuum of care for patients with 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. LIFT 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.
Two-year follow-up data from the first-in-human trial is expected to be complete this month. 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 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 US and EU.
“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.
Source: ZKR Orthopedics
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
