Smith+Nephew Expands AETOS Shoulder System With New Stemless Option for Anatomic Shoulder Arthroplasty
Smith+Nephew Expands AETOS Shoulder System With New Stemless Option for Anatomic Shoulder Arthroplasty
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance from the United States Food & Drug Administration for a stemless anatomic total shoulder for the AETOS Shoulder System (AETOS Stemless).
全球醫療技術公司Smith+Nephew(倫敦證券交易所代碼:SN,紐約證券交易所代碼:SNN)今天宣佈,它已獲得美國食品藥品監督管理局頒發的510(k)份艾拓思肩部系統(AETOS Stemless)無莖解剖全肩的許可。
AETOS Stemless addresses the growing demand for anatomic total shoulder replacement with a small operating room footprint allowing for an efficient procedure.1 It is designed to maximize metaphyseal fixation and stability with an inlay collar, cruciate fins, and porous titanium coating to encourage biological fixation.2-6
AETOS Stemless 以較小的手術室佔地面積實現高效手術,滿足了對解剖學全肩關節置換術不斷增長的需求。1 它旨在通過鑲嵌項圈、十字形鰭片和多孔鈦塗層來促進生物固定,從而最大限度地提高甲狀體固定和穩定性。2-6
Introduced last year, the AETOS Shoulder System delivers an elegant design and an elevated experience through its simplicity, uniformity and flexibility. The new stemless implant expands the AETOS Shoulder System portfolio enabling streamlined convertibility from Stemless to Meta Stem.1-3
去年推出的AETOS肩部系統通過其簡單、均勻和靈活性提供了優雅的設計和更高的體驗。新的無莖植入物擴展了AETOS肩部系統的產品組合,從而簡化了從無莖到Meta Stem的轉換性。1-3
"AETOS Stemless represents a significant advancement in shoulder arthroplasty, underscoring our commitment to superior patient outcomes and driving progress in the field of orthopaedic surgery. We are excited to continue unveiling future technologies that will reshape the treatment of shoulder conditions," said Craig Gaffin, President of Global Orthopaedics for Smith+Nephew. "With AETOS Stemless, we're now able to further personalize surgery, providing options that help surgeons give patients the best chance for recovery and a return to living their Life Unlimited."
「AETOS Stemless代表了肩關節置換術的重大進步,凸顯了我們對卓越患者療效的承諾,並推動了骨科手術領域的進步。我們很高興繼續推出將重塑肩部疾病治療的未來技術。」 Smith+Nephew全球骨科總裁克雷格·加芬說。「藉助AETOS Stemless,我們現在能夠進一步實現個性化手術,提供多種選擇,幫助外科醫生爲患者提供最佳康復機會,重返無限生活。」
Total shoulder arthroplasty is one of the fastest growing segments in Orthopaedics with an estimated 250,000 procedures annually in the US by 2025.7
全肩關節置換術是骨科中增長最快的細分市場之一,到2025年,美國每年估計要進行25萬例手術。7
Cleared for use in the United States and approved for use in Canada, the AETOS Shoulder System, including AETOS Stemless, is the latest solution in Smith+Nephew's expanding Upper Extremity portfolio - complementing our market leading Sports Medicine shoulder repair and biologics solutions. To learn more, please visit:
包括AETOS Stemless在內的AETOS肩部系統已獲准在美國使用並獲准在加拿大使用,是Smith+Nephew不斷擴大的Upper Extremity產品組合中的最新解決方案,是對我們市場領先的運動醫學肩部修復和生物製劑解決方案的補充。要了解更多信息,請訪問:
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Enquiries
查詢
Dave Snyder +1 (978) 749-1440
Smith+Nephew david.snyder@smith-nephew.com
戴夫·斯奈德 +1 (978) 749-1440
Smith+Nephew david.snyder@smith-nephew.com
References
參考文獻
- Smith+Nephew 2023. AETOS Instruments & Trays. Internal Report. ER-04-0990-0020 REV B.
- Smith+Nephew 2023. AETOS Inlay Design Features. Internal Report. ER-04-0990-0017 REV C.
- Smith+Nephew 2024. AETOS Short Stem Stability Report. Internal Report. ER-04-0990-0008 REV AC
- Carpenter SR, Urits I, Murthi AM. Porous metals and alternate bearing surfaces in shoulder arthroplasty. Curr Rev Musculoskelet Med. 2016;9(1):59-66
- Godenèche A, Garret J, Barth J, Michelet A, Geais L. Comparison of revision rates and radiographic observations of long and short, uncoated and coated humeral stem designs in total shoulder arthroplasty. EFORT Open Rev. 2019;4(2):70-76.
- Morwood MP, Johnston PS, Garrigues GE. Proximal ingrowth coating decreases risk of loosening following uncemented shoulder arthroplasty using mini-stem humeral components and lesser tuberosity osteotomy. Journal of Shoulder and Elbow Surgery. 2017;26(7):1246-1252
- SmartTrak Report, 2023
- Smith+Nephew 2023。AETOS 儀器和托盤。內部報告。ER-04-0990-0020 REV b.
- Smith+Nephew 2023。AETOS 鑲嵌設計功能。內部報告。ER-04-0990-0017 REV C.
- Smith+Nephew 2024。AETOS 短莖穩定性報告內部報告。ER-04-0990-0008 REV AC
- Carpenter SR、Urits I、Murthi Am。肩關節置換術中的多孔金屬和替代承載表面。Curr Rev Musculoskelet Med. 2016;9 (1): 59-66
- Godeneche A、Garret J、Barth J、Michelet A、Geais L. 比較全肩關節置換術中長而短、無塗層和塗層的肱骨幹設計的修訂率和射線照相觀察。eFort Open Rev. 2019; 4 (2): 70-76。
- 莫伍德議員,約翰斯頓議員,嘉理蓋斯通用電氣。近端向內生長塗層使用微型肱骨幹成分和較小結節性截骨術,可降低未固結肩關節置換術後鬆動的風險。肩肘外科雜誌. 2017; 26 (7): 1246-1252
- 2023 年 SmartTrak 報告
About Smith+Nephew
關於 Smith+Nephew
Smith+Nephew is a portfolio medical technology business focused on the repair, regeneration and replacement of soft and hard tissue. We exist to restore people's bodies and their self-belief by using technology to take the limits off living. We call this purpose 'Life Unlimited'. Our 18,000 employees deliver this mission every day, making a difference to patients' lives through the excellence of our product portfolio, and the invention and application of new technologies across our three global business units of Orthopaedics, Sports Medicine & ENT and Advanced Wound Management.
Smith+Nephew是一家投資組合醫療技術公司,專注於軟組織和硬組織的修復、再生和置換。我們的存在是爲了通過使用技術來打破生活的極限來恢復人們的身體和自信心。我們稱這個目標爲 「生命無限」。我們的 18,000 名員工每天都在履行這一使命,通過我們卓越的產品組合,以及在骨科、運動醫學與耳鼻喉和高級傷口管理這三個全球業務部門中發明和應用新技術,改變患者的生活。
Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.5 billion in 2023. Smith+Nephew is a constituent of the FTSE100 (LSE:SN, NYSE:SNN). The terms 'Group' and 'Smith+Nephew' are used to refer to Smith & Nephew plc and its consolidated subsidiaries, unless the context requires otherwise.
我們於1856年在英國赫爾成立,現在業務遍及100多個國家,2023年年銷售額達到55億美元。Smith+Nephew 是 FTSE100(倫敦證券交易所代碼:SN,紐約證券交易所代碼:SNN)的組成部分。除非上下文另有要求,否則術語 「集團」 和 「Smith+Nephew」 用於指Smith & Nephew plc及其合併子公司。
For more information about Smith+Nephew, please visit and follow us on X, LinkedIn, Instagram or Facebook.
有關 Smith+Nephew 的更多信息,請訪問並在 X、LinkedIn、Instagram 或 Facebook 上關注我們。
Forward-looking Statements
前瞻性陳述
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading profit margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith+Nephew, these factors include: conflicts in Europe and the Middle East, economic and financial conditions in the markets we serve, especially those affecting healthcare providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal and financial compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and disposals, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; relationships with healthcare professionals; reliance on information technology and cybersecurity; disruptions due to natural disasters, weather and climate change related events; changes in customer and other stakeholder sustainability expectations; changes in taxation regulations; effects of foreign exchange volatility; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith+Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith+Nephew's most recent annual report on Form 20-F, which is available on the SEC's website at www. sec.gov, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith+Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith+Nephew are qualified by this caution. Smith+Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith+Nephew's expectations.
本文件可能包含前瞻性陳述,這些陳述可能被證明是準確的,也可能不準確的。例如,關於預期收入增長和交易利潤率、市場趨勢和我們的產品線的陳述均爲前瞻性陳述。諸如 「目標」、「計劃」、「打算」、「預測」、「恰當定位」、「相信」、「估計」、「期望」、「目標」、「考慮」 等短語通常用於識別前瞻性陳述。前瞻性陳述涉及已知和未知的風險、不確定性和其他重要因素,這些因素可能導致實際結果與陳述所表達或暗示的結果存在重大差異。對於 Smith+Nephew 而言,這些因素包括:歐洲和中東的衝突、我們所服務的市場的經濟和財務狀況,尤其是影響醫療保健提供者、付款人和客戶的狀況;成熟和創新醫療器械的價格水平;醫療技術的發展;監管批准、報銷決定或其他政府行動;產品缺陷或召回或其他質量管理體系中的其他問題或未能遵守相關法規;與專利或其他索賠相關的訴訟;法律和財務合規風險及相關的調查、補救或執法行動;我們的供應鏈或運營中斷或供應商供應鏈或運營中斷;對合格人員的競爭;戰略行動,包括收購和處置;我們在開展盡職調查、估值和整合收購業務方面的成功;我們爲適應市場發展而對業務計劃或組織所做的交易或其他變更可能造成的中斷;與醫療保健專業人員的關係;對信息技術的依賴網絡安全;自然災害、天氣和氣候變化相關事件造成的中斷;客戶和其他利益相關者對可持續發展的期望的變化;稅收法規的變化;外匯波動的影響;以及影響我們或我們市場的許多其他問題,包括政治、經濟、商業、競爭或聲譽性質的問題。有關其中某些因素的討論,請參閱Smith+Nephew根據經修訂的1934年美國證券交易法向美國證券交易委員會提交的文件,包括Smith+Nephew最新的20-F表年度報告,該報告可在美國證券交易委員會的網站www.sec.gov上查閱。任何前瞻性陳述均基於截至聲明發表之日Smith+Nephew獲得的信息。所有歸因於 Smith+Nephew 的書面或口頭前瞻性陳述均受此警告的限制。Smith+Nephew不承擔任何義務更新或修改任何前瞻性陳述以反映情況或Smith+Nephew預期的任何變化。
◊ Trademark of Smith+Nephew. Certain marks registered in US Patent and Trademark Office.
◊ 史密斯+侄子的商標。在美國專利商標局註冊的某些商標。