Smith+Nephew’s REDAPT◊ System for revision total hip arthroplasty to be launched in China

施乐辉公司用于全髋关节置换翻修术的REDAPT^◊系统将在中国推出

One of the pioneers of 3D-printed, imported, acetabular components approved for use in China
进口3D打印髋臼组件的先行者之一——REDAPT系统髋臼组件在中国被批准使用

 
Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business, announced it has received approval from the National Medical Products Administration (NMPA) in China to introduce its REDAPT System for revision total hip arthroplasty (rTHA). The REDAPT System’s acetabular components are among the pioneers of 3D-printed, imported, acetabular product approved for use in China – enabling greater accessibility for customers and patients.
全球医疗器械公司施乐辉(LSE:SN, NYSE:SNN)宣布已获得中国国家药品监督管理局 (NMPA)的批准，在中国推出REDAPT系统用于全髋关节置换 (rTHA)翻修。REDAPT系统的髋臼组件是经中国批准使用的3D打印进口髋臼产品的先行者之一，使客户和患者的使用更加便捷。

“China has seen rapid growth in primary hip procedures over the past 15-20 years and as such, there is a need for technologies addressing the clinical needs for revision hip arthroplasty,” said Ala Ahram, Managing Director Greater China, Smith+Nephew. “Introducing the REDAPT System in China will have a profoundly positive clinical impact to our surgeon customers and will help their patients live a Life Unlimited.”
施乐辉公司大中华区董事总经理Ala Ahram说:“在过去的15-20年里，中国的初次髋关节手术量发展迅速，因此，需要有满足髋关节翻修术临床需求的技术。在中国引入REDAPT系统，将对我们的外科医生客户产生深刻而积极的临床影响，并将帮助他们的患者的生命拥有无限可能。”

The REDAPT Revision Hip System is uniquely designed to tackle the challenges of revision hip arthroplasty: fixation in various bone types, achievement of joint stability, predictable stem position, and surgical efficiency.¹ As a result, surgeons are able to treat these patients effectively and efficiently.
REDAPT髋关节翻修系统是专为应对髋关节翻修术的挑战而设计的:各种骨缺损类型的固定、关节稳定性的实现、术中可预见的股骨柄位置和手术效率的提高。因此，外科医生能够有效地治疗病人。

The 3D-printing process used to manufacture standard “off the shelf” acetabular components enables product features that might normally be cost prohibitive.
3D打印工艺用于制造标准的“成品”髋臼组件，实现了原本成本高昂的产品功能。

“I have full confidence in the REDAPT System to address all of my femoral revision needs, including complex reconstructions and periprosthetic fractures,” said Ran Schwarzkopf MD, Associate Professor at NYU Hospital for Joint Diseases and NYU Langone Orthopedic Hospital. “Furthermore, the REDAPT Acetabular cup has unique attributes, including the 3D-printed CONCELOC material, which is designed to provide strong osteo-integration, and the wide variety of holes and locations for both superior and inferior screw placement. The locking screw mechanism is extremely advantageous in poor bone quality and large defects.”
纽约大学关节病医院和纽约大学朗格尼骨科医院的Ran Schwarzkopf博士说:“我对REDAPT系统完全有信心，它能满足我所有的股骨翻修需求，包括复杂的重建和预防假体周围骨折。此外，REDAPT髋臼系统具有独特的属性，包括3D打印的CONCELOC材料，旨在提供强大的骨整合效果，以及专为翻修设计的螺钉孔和钉孔分布，可用于上方和下方的螺钉植入。锁定螺钉机制在骨质量差和骨缺损大的情况下非常有帮助。”

Revision total hip arthroplasty procedure volume is expected to increase globally as younger, more active patients, out-live their original implants.
全髋关节翻修置换术的手术量有望在全球范围内增加，因为更加年轻活跃的患者会比首次接受的植入物存活的时间更长。

The REDAPT System is designed to deliver reliable stability and help lower the re-revision rate of rTHAs by reducing the frequency of implant movement– a major contributor to early failure of total hip arthroplasty.
REDAPT系统旨在提供可靠的稳定性，并通过减少植入物的微动来帮助降低翻修手术的再次翻修率——这是全髋关节置换术早期失败之后的一个主要的解决方案。

“Titanium tapered stems - particularly those with aggressive tapers like REDAPT - have really changed the face of revision hip arthroplasty in the last decade and have made what was a previously complex procedure much more straightforward,” said Prof. Fares S. Haddad MD, Professor of Orthopaedic and Sports Surgery, University College of London. “They sit where planned and hold position following surgery; they have become our workhorse for femoral revision.”
英国伦敦大学骨科和运动外科教授Fare S. Haddad博士说：“钛合金锥形柄——尤其是像REDAPT这种较大锥度的椎形柄在过去十年间真实改变了人工髋关节置换术的面貌,也使得之前复杂的手术更加简单。钛合金锥形柄在手术后可以固定和保持在计划好的位置，它们已经成为我们股骨翻修手术的主力。”

The addition of the REDAPT System expands Smith+Nephew’s comprehensive portfolio of both primary and revision hip arthroplasty products now available in China. The REDAPT System is available in most major global markets and will be commercially available in China later this year.
REDAPT系统的推出丰富了施乐辉公司在中国现有的初级和翻修髋关节置换术的综合产品组合。REDAPT系统已在全球大多数主要市场上销售，也将于今年晚些时候在中国上市。

Enquiries

Media 
David Snyder +1 867-749-1440
Smith+Nephew 

About Smith+Nephew
关于施乐辉

Smith+Nephew is a portfolio medical technology business that exists 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 17,500+ 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 franchises of Orthopaedics, Advanced Wound Management and Sports Medicine & ENT.
施乐辉是一家综合性医疗器械公司，通过运用技术手段来重塑人们的身体和他们的自信心，解除生活中的限制。施乐辉的使命是——让生命拥有无限可能。我们17500多名员工每天都在履行这一使命，通过我们卓越的产品组合，以及我们在全球三大事业部——骨科、高级伤口管理和运动医学及耳鼻喉的新技术的发明和应用，改变了患者的生活。

Founded in Hull, UK, in 1856, we now operate in more than 100 countries, and generated annual sales of $5.1 billion in 2019. 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.
施乐辉于1856年在英国赫尔市成立，目前在100多个国家开展业务，2019年年销售额达51亿美元。施乐辉是FTSE100的成员(伦敦证交所: SN，纽约证交所: SNN)。除非上下文另有规定，“集团”和“施乐辉”系指施乐辉有限公司及其合并后的子公司。

For more information about Smith+Nephew, please visit www.smith-nephew.com and follow us on Twitter, LinkedIn, Instagram or Facebook.
想了解更多关于施乐辉的信息，请访问www.smith-nephew.com并关注我们的Twitter, LinkedIn, Instagram或Facebook。

Any reposting, distribution or quotation of the above content or any part thereof shall require the prior written consent of Smith+Nephew. Nothing on this webpage should be construed as medical or clinical advice.  For more information on the application of any products discussed in this webpage, as well as indications for use, contraindications, and product safety information, please consult the Instructions for Use (IFU) for such product and qualified healthcare professionals.
任何对上述内容或其任何部分的转发、传播或引用都必须事先获得施乐辉的书面同意。本网页上的任何内容都不应被解释为医疗或临床建议。关于本网页所讨论的任何产品的应用，以及使用适应症、禁忌症和产品安全信息的更多信息，请查阅该产品的说明书并咨询合格的医疗保健专业人士。

^{Forward-looking Statements}

^{This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading 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: economic and financial conditions in the markets we serve, especially those affecting health care 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 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 dispositions, 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; 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, 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.}

^{前瞻性声明}

^{本文件可能包含一些前瞻性陈述，这些陈述可能会或可能不会被证明是准确的。例如，有关预期收入增长和交易利润率、市场趋势和我们的产品系列的陈述是前瞻性陈述。诸如 "目标"、"计划"、"打算"、"预期"、"准备充分"、"相信"、"估计"、"期望"、"目标"、"考虑 "等措辞和类似的表达方式通常是为了识别前瞻性陈述。前瞻性陈述涉及已知和未知的风险、不确定性和其他重要因素，可能导致实际结果与陈述所表达或暗示的内容存在重大差异。对于施乐辉来说，这些因素包括：我们所服务市场的经济和金融状况，特别是那些影响医疗服务提供者、付款人和客户的因素；成熟和创新医疗设备的价格水平；医疗技术的发展；监管部门的批准、报销决定或其他政府行动；产品缺陷或召回或质量管理体系的其他问题或未能遵守相关法规；与专利或其他索赔有关的诉讼；法律合规风险和相关调查、补救或执法行动。我们的供应链或运营或供应商的运营受到干扰；对合格人员的竞争；战略行动，包括收购和处置，我们在履行尽职调查、评估和整合被收购业务方面的成功；交易或我们为适应市场发展而对业务计划或组织做出的其他改变可能导致的干扰；以及影响我们或我们市场的许多其他事项，包括政治、经济、商业、竞争或声誉性质的事项。请参考施乐辉根据《1934年美国证券交易法》（修订版）向美国证券交易委员会提交的文件，包括施乐辉最新的20-F表格年度报告，以了解其中的某些因素。任何前瞻性声明都是基于施乐辉在声明发布之日所掌握的信息。所有归属于施乐辉的书面或口头前瞻性声明均受此声明的限制。施乐辉不承担更新或修改任何前瞻性声明以反映任何情况的变化或施乐辉的预期的义务。}

^{◊ Trademark of Smith+Nephew. Certain marks registered US Patent and Trademark Office.}