Enovis Introduces STAR Ankle, Now With E+ Polyethylene for Unmatched Durability
Enovis Introduces STAR Ankle, Now With E+ Polyethylene for Unmatched Durability
Revolutionary Scandinavian Total Ankle Replacement (STAR Ankle) System Now Includes Vitamin E-Blended Polyethylene Insert
革命性的斯堪的納維亞全踝關節置換(STAR踝關節)系統現已包含維生素E混合聚乙烯插入
STAR Ankle with e+ Polyethylene
科創板e+聚乙烯材質腳踝支撐
Wilmington, DE, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Enovis Corporation (NYSE: ENOV), an innovation-driven medical technology company, proudly unveils its Scandinavian Total Ankle Replacement (STAR Ankle), now with new e+ Polyethylene. Recent U.S. Food and Drug Administration (FDA) approval makes STAR Ankle the first and only mobile bearing ankle system with e+ Polyethylene in the United States.1 The implant's new vitamin E-blended e+ Polyethylene insert will offer improved durability, stability, and longevity.1
2024年8月19日,特拉華州威明頓(GLOBE NEWSWIRE)——創新驅動的醫療技術公司Enovis Corporation(紐交所代碼:ENOV)驕傲地推出了其斯堪的納維亞全踝關節置換(STAR踝關節),現已採用新的e+聚乙烯。美國食品和藥物管理局(FDA)的最新批准使STAR踝關節成爲美國第一個也是唯一一個搭載e+聚乙烯的移動軸承踝關節系統。1該植入物的新型維生素E混合e+聚乙烯插入物將提供更好的耐久性、穩定性和壽命。
"With e+ Polyethylene, we uphold our commitment to the advancement of our total ankle portfolio, merging full oxidative resistance with the time-tested design of the STAR Ankle," said Gary Justak, President and General Manager of Enovis Foot & Ankle. "Building upon the proven success of the STAR Ankle epitomizes our culture of advancing foot and ankle solutions and elevating patient treatment options. We don't just set the standard—we redefine it."
「採用e+聚乙烯,我們不斷推進我們的全踝關節組合產品系列的先進性,將全新的抗氧化性能與經過時間檢驗的STAR踝關節設計相結合,」Enovis Foot&Ankle總裁兼總經理Gary Justak說道,「在證明STAR踝關節的優異效果之上,我們推動了足踝解決方案不斷進步和提高患者治療選擇的文化。我們不只是設置標準,我們重新定義它。」
e+ Polyethylene contains the free radical-neutralizing antioxidant vitamin E; as a result, the material resists oxidation and maintains consistent wear rates and stable mechanical properties over time. In contrast, other highly crosslinked polyethylenes are remelted during manufacturing to neutralize free radicals2, a process that can reduce their mechanical strength by up to 12%.1,3
e+聚乙烯含有自由基中和抗氧化劑維生素E;因此,該材料抵禦氧化,保持一致的磨損率和穩定的機械性能。相比之下,其他高度交聯的聚乙烯在製造過程中被重新熔融,以中和自由基2,該過程可能會將其機械強度降低高達12%。1,3
"After extensive clinical experience with this superior material in knee and shoulder implants, along with years of laboratory testing, I expect improved patient outcomes through increased polyethylene longevity. This builds on the outstanding STAR Ankle long-term metal-component survival rates seen in multiple clinical studies," stated Dr. Gregory Lundeen, a foot and ankle orthopedic surgeon at Reno Orthopedic Center.
「經過對該卓越材料在膝蓋和肩膀植入物上的廣泛臨床經驗以及多年實驗室測試,我希望通過增加聚乙烯壽命來改善患者的效果。這在多項臨床研究中看到了STAR踝關節長期金屬部件存活率的傑出成果,」Reno Orthopedic Center的足踝骨科醫生Gregory Lundeen博士表示。
Combined with the recent release of STAR Patient Specific Instrumentation (PSI), the STAR+ Experience represents Enovis' commitment to continuous improvement, aimed at enhancing patient satisfaction and outcomes. The integration of e+ Polyethylene in the STAR Ankle continues to enhance the remarkable success of this implant, which has been used globally over 40,000 times across its 37-year history.4
加上最近推出的STAR患者特異性儀器(PSI),STAR+體驗表明Enovis致力於不斷改進,旨在增強患者的滿意度和結果。將e+聚乙烯集成到STAR踝關節中,繼續提高這種植入物的顯著成功,該植入物在其37年的歷史中已在全球使用超過40000次。4
For more information about the STAR Ankle with e+ Polyethylene and Enovis' innovative foot and ankle solutions, please visit .
有關搭載e+聚乙烯的STAR踝關節和Enovis創新的足踝解決方案的更多信息,請訪問 .
Individual results may vary. Neither Enovis Corporation nor any of its subsidiaries dispense medical advice. The contents of this release do not constitute medical, legal, or any other type of professional advice. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you.
個人結果可能有所不同。Enovis Corporation及其附屬公司不提供醫療建議。本文不構成醫學、法律或任何其他類型的專業建議。請諮詢您的醫療保健專業人員,以獲取有關適合您的治療方案及其它方面的信息。
Dr. Gregory Lundeen is a consultant for Enovis Corporation.
Gregory Lundeen博士是Enovis Corporation的顧問。
References
參考
- e+ testing data on file. Bench test results not necessarily indicative of clinical performance.
- Jennings et al. The influence of femoral condylar lift-off on the wear of artificial knee joints. Proc Inst Mech Eng [H]. 2007 Apr;221(3):305-14.
- S.M. Kurtz. "The UHMWPE Handbook: Ultra-high Molecular Weight Polyethylene in Total Joint Replacement". Elsevier Academic Press, 2009.
- Enovis internal document: Includes world-wide implantations of all generations; newest generation has over 40,000 world-wide from 1998-2022
- 文件中包含的e+測試數據。台架測試結果不一定能反映臨床性能。
- 詹寧斯等人。股骨髁脫離對人工膝關節磨損的影響。機械工程師協會會議講稿[H]。2007年4月;221(3):305-14。
- S.m. Kurtz. 「UHMWPE手冊:超高分子量聚乙烯全關節置換」。Elsevier Academic Press,2009。
- Enovis內部文件:包括所有世代的全球植入;最新一代的全球範圍內已經使用了超過40,000次,時間是1998-2022年。
About Enovis
關於Enovis
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services, and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .
Enovis Corporation(紐交所代碼:ENOV)是一家創新驅動的醫療技術增長公司,致力於開發產生可測量更好患者結果和轉換工作流程的臨床差異化解決方案。在不斷改進、全球人才和創新的文化推動下,公司廣泛的產品、服務和綜合技術範圍推動骨科和其他領域的積極生活方式。有關Enovis的更多信息,請訪問 .
Media Contact
媒體聯繫人
Diana Aldermae
Diana Aldermae
Enovis Foot & Ankle
Enovis Foot&Ankle
Diana.Aldermae@enovis.com
Diana.Aldermae@enovis.com
MK-10554
Mk-10554
Attachment
附件
- STAR Ankle with e+ Polyethylene
- 科創板e+聚乙烯材質腳踝支撐