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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.
加利福尼亚州肯特菲尔德,2023年10月9日(GLOBE NEWSWIRE)-临床阶段医疗器械公司ZKR Orthopedics,Inc。今天宣布其LIFT植入技术已获得美国食品和药物管理局(FDA)的突破性设备认证。LIFT植入物旨在减轻疼痛,改善功能,延迟或消除膝关节置换的需要。
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.
如果获得FDA的上市许可,LIFT技术将扩大对患有晚期软骨退化和膝关节髌股关节室骨关节炎的患者的持续护理。此外,其设计可以放大伴随手术(例如软骨移植和微骨折)治疗髌股关节软骨退变的功效。
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.
提升植入物通过减小压缩力并将髌骨跟踪移向更健康的软骨来提升和重新对准髌骨肌腱,其卸载髌股隔室。LIFT系统包括试用垫片,PEEK植入物,钛骨螺钉,K线和专有定位仪器。
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.
试验垫片和定位仪器有助于最佳的种植体尺寸选择和髌骨肌腱下的定位。植入物暂时由K线固定到位。使用三个标准骨螺钉实现永久固定。外科手术被设计为在门诊环境中进行的微创手术。
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.
髌股关节软骨退变是影响大约700万美国人的常见病症。这种退行性疾病的流行是由髌骨排列不齐的常见发病率,人口因素和肥胖流行所驱动的。越来越多的临床文献估计。