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February 2-4, 2017
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HSS Study Finds Consensus Needed for Joint Replacement Performance Measurement

March 9, 2018 OrthoSpineNews

NEW ORLEANS, March 9, 2018 /PRNewswire-USNewswire/ — Researchers from Hospital for Special Surgery (HSS), a world leader in musculoskeletal research and care, are calling for greater consensus in the orthopedic community around standardizing methods used to calculate patient-reported outcome measures (PROMs) for hip and knee replacements. Their research shows that current performance measures varied significantly depending on which method was applied when assessing outcomes from these procedures. These results were presented today at the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting.

“While significant progress has been made collecting PROMs data for joint replacements, no guidelines exist on the most accurate way to analyze these data to objectively measure and improve performance,” said lead author Stephen Lyman, PhD, associate scientist at HSS. “Before policies are enacted, clinicians and payers must reach a consensus about which measures reflects the meaningful improvement in joint-related health.”

PROMs are considered the gold standard for evaluating the effectiveness of hip or knee replacement procedures. Two of the most commonly utilized PROMs for the hip and knee are the Hip Disability and Osteoarthritis Outcomes Survey (HOOS), the Knee Injury and Osteoarthritis Outcomes Survey (KOOS), respectively, and their short form versions HOOS, JR. and KOOS, JR., respectively. The Centers for Medicare and Medicaid Services (CMS) have adopted these surveys in their Comprehensive Care for Joint Replacement (CJR) Model, which is a bundled payment plan for all primary elective total joint replacements performed in eligible Medicare patients.

This study, performed at HSS, included 2,323 people who underwent a total hip replacement procedure, and 2,630 people who underwent a total knee replacement procedure. Meaningful change of PROMs can be assessed using three measures: Minimal Detectable Change (MDC), Minimal Clinically Important Change, and Substantial Clinical Benefit. Answers from the HOOS and KOOS (original or JR.) are used to score these measures and currently several different methods can be applied to calculate the total score.

The results showed that there is wide variability in benchmarks when these methods are used to calculate them:

  • Distribution-based approach, which relies on distribution of the data and assumes a normal distribution of responses and does not include patient input.
  • Anchor-based approach, a patient-centric approach where an anchor question on the HOOS/KOOS regarding patient perception of a change in health is used to assess the change in PROMs scores.
  • Anchor-based ROC approach, which uses the area under the ROC curve to determine the optimal delta score that best predicts those who experienced a minimal improvement and those who did not and does not include patient input.

“We believe meaningful use of PROMs to assess care delivery and quality requires an understanding of how much change over time should be expected and how much change matters to patients,” Alexander McLawhorn, MD, MBA, an orthopedic surgeon at HSS. “The anchor-based assessment is the only method that accounts for the patients’ perspective.”

“We hope this analysis sparks important discussions about how quality and appropriateness are measured,” said senior author Catherine H. MacLean, MD, PhD, chief value medical officer at HSS. “The orthopedic community must be careful before we start using PROMs scores for performance evaluations, and as a next step HSS researchers plan to explore in depth the care experience and broad outcomes of patients in relation to changes in their patient reported outcome scores.”

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country, and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients from 80 countries, and performed more than 32,000 surgical procedures. In addition to Patient Care, HSS leads the field in research, innovation, and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair, and tissue regeneration. The HSS Innovation Institute was formed in 2015 to realize the potential of new drugs, therapeutics and devices; the global standard total knee replacement was developed at HSS in 1969, and in 2017 HSS made 130 invention submissions (more than 2x the submissions in 2015). The HSS Education Institute provides continuing medical curriculum to more than 15,000 subscribing musculoskeletal healthcare professionals in 110 countries. Through HSS Global, the institution is collaborating with medical centers worldwide to advance the quality and value of care, and to make world-class HSS care more accessible to more people.

SOURCE Hospital for Special Surgery

Related Links

http://www.hss.edu

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Four-Year Data from the UK National Joint Registry Highlights High Survivorship in Patients Treated with the Conformis iTotal CR

March 9, 2018 OrthoSpineNews

BILLERICA, Mass., March 07, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit and conform to each patient’s unique anatomy, today announced new data showing that patients treated with the Conformis iTotal CR knee implant experienced a cumulative revision rate of 0.5% at four years compared to a 1.9% cumulative revision rate at the same time-point, among all patients who underwent knee replacement.1Results are summarized in a February 2018 report from Beyond Compliance, based on data available in the National Joint Registry (NJR) in the U.K.

In total or partial knee arthroplasty, revision surgery may be required to address problems, including loosening, instability, and infection following an original implant procedure. The summary data in this report includes 576 iTotal implant procedures in 504 patients treated at 46 different centers in the U.K.1 Among all patients treated with Conformis iTotal implants, only three patients (0.5%) required revision surgery up to four years following surgery.1

“The new four-year data highlighting the low risk of revision surgery for patients treated with Conformis iTotal implants provides strong clinical evidence reinforcing survivorship of our implant technology,” said Mark Augusti, President and CEO of Conformis. “We are pleased to add this data summary to our growing body of clinical evidence supporting the many benefits our product provides to patients. Announcement of this new safety data is on the heels of our most recent announcement that the Orthopaedic Data Evaluation Panel (ODEP) in the U.K. awarded the Conformis iTotal CR knee replacement system a ‘3A’ rating. This positive 3A rating is based on strong evidence of implant performance over a three-year period; including low revision rates noted in this report.”    http://www.odep.org.uk/product.aspx?pid=4305

“When adopting new technology, surgeons must assess how the new technology maintains established standards for safety and efficacy, “said Raj Sinha, MD, PhD from S.T.A.R. Orthopedics in Rancho Mirage, CA. “This recent data from the UK demonstrates that the Conformis iTotal CR provides excellent survivorship, evidenced by the low revision rates. This continues to prove the considerable benefits of treating my patients with the Conformis iTotal Knee Replacement System.”

Conformis iTotal is the only patient-conforming total knee replacement for which the implant design and manufacture is based on each patient’s anatomy and offers effective patient based advantages compared to standard off-the-shelf implants, including patient conforming sizes and better bone preservation. Study results from Levengood et. al. published in the peer-reviewed orthopedic journal, The Journal of Knee Surgery, in December 2017 showed that 100% of patients treated with iTotal CR achieved mechanical alignment in the target range of +/-3%. Neutral mechanical limb alignment (alignment within +/-3 °) has previously been linked to better long-term survivorship in TKA, while poor alignment has been linked to higher rates of implant failure.

“As a surgeon, we always strive to provide the best alternatives for our patients,” said Mr. Ian McDermott, MB BS, MS, FRCS (Tr&Orth), FFSEM(UK) affiliated with London Bridge Hospital in London, United Kingdom. “This 4-year National Joint Registry data confirms the positive early results I am seeing with my Conformis patients with respect to survivorship, in addition to published studies that continue to show effective positive outcomes I am seeing with faster recovery, improved kinematics and overall patient satisfaction.”

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are designed and manufactured to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of patient conforming total and partial knee systems that include sterilized single-use instruments delivered in a single package to the hospital. Conformis owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover patient-specific implants and instrumentation for all major joints.

For more information, visit www.conformis.com.

1 Implant Summary Report for the iTotal G2 XE and iTotal G2 (Bicondylar tray).  Beyond Compliance database February 11, 2018, pages 19-20. This report has been produced by Northgate Public Services (UK) Ltd. (NPS) based on data collected by the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Conformis, including statements about the ability to offer implants to patients in the United Kingdom, that potential clinical benefits or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Conformis views as of the date hereof. Conformis anticipates that subsequent events and developments may cause Conformis’s views to change. However, while Conformis may elect to update these forward-looking statements at some point in the future, Conformis specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Conformis’ views as of any date subsequent to the date hereof.

MEDIA CONTACT

Kelly Wakelee
Berry and Company Public Relations
kwakelee@berrypr.com
212.253.8881

INVESTOR RELATIONS CONTACT

Oksana Bradley
Investor Relations
ir@conformis.com
781.374.5598
www.conformis.com

Image courtesy of Conformis

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LimaCorporate Awarded With Two New ODEP Ratings for the SMR Reverse

March 8, 2018 OrthoSpineNews

SAN DANIELE DEL FRIULI, Italy, March 7, 2018 /PRNewswire/ —

LimaCorporate is proud to announce that the SMR Shoulder System has recently been awarded by the Orthopaedic Data Evaluation Panel (ODEP) in the UK, with the following two ratings (ODEP ratings can be found on odep.org.uk):

  • 10A ODEP Rating – SMR Reverse with Uncemented Fixation (Metal Glenosphere / Polyethylene Liner Combination);
  • 5A ODEP Rating – SMR Reverse HP with Uncemented Fixation (Polyethylene Glenosphere / Metal Liner Combination).

The Orthopaedic Data Evaluation Panel (ODEP) was set up in the United Kingdom in 2002 and provides ongoing assessment of arthroplasty implants to benchmark Hip, Knee and Shoulder implants, providing a standard rating for their survivorship and data submission quality.

Shoulder ratings are provided at benchmarks of 3, 5, 7 and 10 years of follow-up alongside a ‘A’ or ‘B’ rating dependent upon the strength of evidence and the quality of the data provided. The main criteria are the survivorship of the implants, the number of patients and the length of follow-up. Many countries outside the United Kingdom now use these ratings to assist in their approval of products into the market place. ODEP ratings provide a simple, independently verified assessment of the performance of an implant, assessed against Clinical best practice guidelines.

LimaCorporate is proud to remark that the SMR Reverse (Uncemented with Metal Glenosphere) was awarded an ODEP 10A rating in 2017 and it is currently the only Shoulder replacement system to be awarded with a 10A benchmark. This achievement, together with the celebration of its 15th Anniversary last year, is a further evidence of the outstanding Clinical heritage of the SMR System. The SMR System was the first Shoulder modular platform to be launched on the market in 2002, and it has since then encountered the appreciation of a wide number of surgeons world-wide.

“I am very happy for the high ODEP rating for the SMR Reverse and HP implants, it matches perfectly with my surgical experience and the satisfaction of my patients,” said Dr. Alessandro Castagna.

To reinforce the strong position held by the SMR System, during the second half of 2018, the SMR TT Hybrid Glenoid will be launched in the US. The SMR TT Hybrid Glenoid features LimaCorporate’s core 3D printed technology, Trabecular Titanium, offering to surgeons an innovative solution for Glenoid replacement. Thanks to its modularity, the SMR TT Hybrid Glenoid is the first convertible Hybrid Glenoid implant on the market that allows to convert from anatomic to reverse implant design without the need to remove the TT centralpeg. The SMR TT Hybrid Glenoid offers an optimized range of sizes, mismatch and thicknesses options to allow an appropriate soft tissues management.

“The achievement of the ODEP 10A rating for the SMR Reverse is yet another recognition for our remarkable technology. On behalf of all of LimaCorporate, I would like to thank the surgeon community that believed in the SMR System from the beginning”, said Luigi Ferrari, Chief Executive Officer of LimaCorporate.

About LimaCorporate

LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.

For additional information on the Company, please visit: limacorporate.com

Limacorporate S.p.A.
Via Nazionale, 52
33038 Villanova di San Daniele del Friuli
Udine – Italy
T: +39-0432-945511
E: info@limacorporate.com

SOURCE Limacorporate S.p.A

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United Orthopedic Corporation Launches UTS™ Hip Stem and an Extension of its U-Motion II™ Acetabular System at AAOS Annual Meeting

March 8, 2018 OrthoSpineNews

IRVINE, Calif., March 7, 2018 /PRNewswire/ — United Orthopedic Corporation, a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, announced today, at the American Academy of Orthopaedic Surgeons Annual Meeting in New Orleans, the launch of the UTS™ (United Tri-tapered Short Stem) hip stem and an extension of the U-Motion II™ Acetabular System.

“We are committed to developing quality, innovative orthopedic products that improve patient outcomes and address the market’s needs,” said Calvin Lin, President of United Orthopedic Corporation USA. “Our unique vertically integrated manufacturing model has enabled us to launch two products which provide surgeons with more treatment options for total hip replacement. One is the UTS™ hip stem, which facilitates less invasive surgery and aids in rapid recovery. The other is a new cup and cup liner – an extension of the U-Motion II™ Acetabular System – which is designed to reduce the risk of dislocation following a total hip replacement.”

The UTS™ hip stem – ideal for the direct anterior approach for total hip replacement – is a tapered wedge short stem suitable for less invasive primary hip replacement surgery. It is designed for easier insertion through small incisions and requires simpler femoral preparation, enabling rapid recovery. Shorter stems preserve bone, which allows for more favorable conditions in future revisions.i The UTS™ hip stem is available in 14 refined proximal sizes. Its features include:

  • Standard and high offset options for restoring joint biomechanics
  • Triple taper design with Titanium Plasma coating that provides initial fixation and enhances rotation stability
  • Reduced lateral shoulder designed to conserve bone in the greater trochanter

The demand for primary total hip arthroplasties is estimated to grow by 174% to 572,000 by 2030, while the demand for hip revisions is projected to double by 2026.ii Dislocation continues to be one of the most common causes of failure after primary and revision total hip arthroplasty. Clinical studies show large femoral heads decrease the incidence of dislocation after total hip arthroplasty.iii

The extension of the U-Motion II™ Acetabular System for total hip replacement surgery includes a 50mm acetabular cup and cup liner, which is compatible with the 36mm BIOLOX® delta ceramic and CoCrMo metal femoral heads. The pole thickness of the liner is 5.3mm, which is greater than ISO 21315’s requirement of 5mm to reduce the risk of breakage. The 36mm femoral head with the new U-Motion II™ 50mm Acetabular cup will provide patients a greater range of motioniv, increase jumping distance, improve stability and lower the risk of dislocation.

About United Orthopedic Corporation
United Orthopedic Corporation is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. United Orthopedic Corporation’s offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. United Orthopedic Corporation operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact
Erich Sandoval
Lazar Partners Ltd.
Tel: +1 917-497-2867
Email: esandoval@lazarpartners.com

_____________________________
i Molli RG,et al. A Short Tapered Stem Reduces Intraoperative Complications in Primary Total Hip Arthroplasty. Clin Orthop Relat Res. 2012 Feb;470(2):450-61.

ii Kurtz, et al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5.

iii Howie, et al. Large femoral heads decrease the incidence of dislocation after total hip arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Jun 20;94(12):1095-102. doi: 10.2106/JBJS.K.00570.

iv Guyen O. Constrained liners, dual mobility or large diameter heads to avoid dislocation in THA. EFORT Open Reviews. 2016;1(5):197-204. doi:10.1302/2058-5241.1.000054.

 

SOURCE United Orthopedic Corporation

Related Links

http://www.uocusa.com

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WishBone Medical, Inc. and Hospital for Special Surgery (HSS) Collaborate to Develop a Novel Pediatric Total Hip Implant.

March 8, 2018 OrthoSpineNews

NEW YORK, March 07, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc., a new global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants, entered into a license agreement with the global leader in orthopedic surgery, Hospital for Special Surgery (HSS), for the development of a novel Pediatric Total Hip. The system will be developed to address treatment of juvenile idiopathic arthritis (JIA) patients or young patients with congenital dysplastic hip (CDH) disease.

“We look forward to working with HSS on a Pediatric Total Hip system designed just for kids,” said Nick Deeter, Chairman of the Board and CEO at WishBone Medical. “HSS is the premier musculoskeletal hospital in the world and their expertise and collaboration will be invaluable to develop this technology.”

“HSS’s clinical leadership, biomechanical engineering and innovation expertise together with Wishbone’s experience developing technologies to serve pediatric patients, position us to improve the quality of life of these young patients who do not have many therapeutic options,” said Louis A. Shapiro, president and CEO of HSS. “As an inventor of these technologies, Dr. Mark Figgie, our Chief of the Surgical Arthritis Service at HSS is a leading expert in the field, who along with our biomechanical engineers have a long history in both treating and innovating for this patient population,” Shapiro added.

About WishBone Medical, Inc.

WishBone Medical is a Global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits, to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing. To learn more about WishBone Medical, visit www.WishBoneMedical.com

For more information, please call Andrew Miclot, Vice-Chairman and President at 574-306-4006 or email CustomerService@WishBoneMedical.com.

About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the eighth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2017-2018). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients from 80 countries and performed more than 32,000 surgical procedures. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Innovation Institute was formed in 2015 to realize the potential of new drugs, therapeutics and devices; the global standard total knee replacement was developed at HSS in 1969, and in 2017 HSS made 130 invention submissions (more than 2x the submissions in 2015). The HSS Education Institute provides continuing medical curriculum to more than 15,000 subscribing musculoskeletal healthcare professionals in 110 countries. Through HSS Global, the institution is collaborating with medical centers worldwide to advance the quality and value of care and to make world-class HSS care more accessible to more people.

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Corin Group Launches Unity Knee™ with EquiBalance™ at AAOS 2018 Annual Meeting

March 7, 2018 OrthoSpineNews

NEW ORLEANS, March 7, 2018 /PRNewswire/ — Corin Group, a global orthopaedic manufacturer and leader in functional implant positioning, today announced the launch of the new Unity Knee™ with EquiBalance™ instrumentation designed to facilitate ligament balancing and soft tissue preservation during total knee replacement. The announcement was made here at the American Academy of Orthopaedic Surgeons (AAOS) 2018 Annual Meeting.

While conventional instruments used in knee replacement may alter the natural joint line, the Unity Knee with EquiBalance preserves the joint line to help enable ligament balancing and medial collateral ligament (MCL) isometry, effectively achieving functional positioning of the knee. This may improve implant stability and performance, and reduce pain and discomfort after knee replacement.

“The new knee system minimizes the impact on soft tissue and enables maintenance of both the distal and posterior medial joint line throughout the range of motion, which may result in improved patient function and joint stability,” said orthopaedic surgeon Stefan Kreuzer, MD of INOV8 Orthopedics in Houston, TX.* “Everybody’s knee is different and what may be natural alignment for one may be different for another. The Unity Knee with EquiBalance lets surgeons make adjustments based on specific patient anatomy and movement,” said Dr. Kreuzer.

“Corin continues to embrace and advance the science and practice of personalization and functional positioning in joint replacement with meaningful and evidence-based innovation that respects the individual differences in patient anatomy and movement,” said Paul Berman, President, Corin USA.

About Corin Group

Corin is a European orthopaedic manufacturer based in the UK that markets its products throughout the world.

Corin is committed to:

…improving patient satisfaction with personalized technologies that optimize our clinically proven joint replacements

…delivering a personal approach to our customers, combining the spirit of our local companies with the strength of our global, integrated organization

…empowering and rewarding our global talented teams to deliver excellence to our customers

For further information about Corin, please visit www.coringroup.com.

*Paid consultant to Corin

 

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Smith & Nephew announces full commercial release of JOURNEY™ II XR Total Knee Arthroplasty

March 7, 2018 OrthoSpineNews

LONDON, March 6, 2018 /PRNewswire/ — Smith & Nephew (LSE:SN, NYSE: SNN), the global medical technology business, today announces the full commercial release of bi-cruciate retaining JOURNEY II XR total knee arthroplasty (TKA) in the United States and Japan.

JOURNEY II XR is the next step in the evolution of total knee replacement surgery. By retaining, rather than substituting, the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), JOURNEY II XR is designed to combine the greater patient satisfaction of a partial knee replacement with the long-term survivorship and reproducible principles of TKA1-2. JOURNEY II XR accomplishes this by eliminating the past concerns of bi-cruciate retaining knees through:

  • An implant design that reflects more accurate replication of the knee anatomy3
  • A robust tibial baseplate designed for optimal fixation and fatigue strength
  • The application of Smith & Nephew’s VERILAST™ Technology, an advanced bearing surface designed to provide lasting survivorship4
  • The introduction of enabling technologies such as NAVIO™ robotics-assisted surgery and VISIONAIRE™ patient matched adaptive guides to help deliver highly reproducible outcomes

Mike Donoghue, Senior Vice President, Global Orthopaedic Marketing said, “The JOURNEY II XR knee offers surgeons an innovative treatment option for arthritic patients who have intact and well-functioning cruciate ligaments. The retention of the cruciate ligaments may provide patients with more normal feel and stability throughout the range of motion, and may lead to a smoother recovery, improved function, and better patient satisfaction.” 3,6-8

JOURNEY II total knee system is designed to achieve normal shapes, position and motion. Smith & Nephew created this platform to empower patients to “rediscover normal” following total knee arthroplasty. The full commercial release of JOURNEY II XR follows a successful limited market release in both the United States and Japan with more than 70 surgeons in both countries implanting over 1,100 JOURNEY II XR knees during the last 18 months9. Join Smith & Nephew at the American Academy of Orthopaedic Surgeons Annual Meeting, Booth #1651 in New Orleans, LA, March 7-9 to experience the Power of Patient Satisfaction and elevate what’s possible with the JOURNEY II XR Knee system.

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

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.

™ Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.

1. Patient satisfaction after primary total and unicompartmental knee arthroplasty: an age-dependent analysis. Von Keudell, Sodha, Collins, Minas, Fitz, Gomoll; Knee. 2014 Jan;21(1):180-4. 2. Total knee replacement with retention of both cruciate ligaments: a 22-year follow-up study. P. Sabouret, F. Lavoie, J-M Cloutier Bone Joint J. 2013 Jul; 95-B(7): 917–922 3. Short-term Range of Motion is Increased after TKA with an asymmetric bicruciate stabilized implant. Accepted Poster Presentation, AAOS 2018 New Orleans. Kaitlin M. Carroll, Peter K. Sculco, Brian CMichaels, Richard L. Murphy, Seth A, Jerabek, David J. Mayman 4. Testing concluded at 45 million cycles, ISO 14242-1 and 14243-3 define test completion at 5 million cycles. 5. Hommel, Hagen, and Kai Wilke. “Good Early Results Obtained with a Guided-Motion Implant for Total Knee Arthroplasty: A Consecutive Case Series.” The Open Orthopaedics Journal 11 (2017): 51–56. PMC. Web. 27 Sept. 2017. 6. Kaneko, Takao et al. Bi-cruciate substituting total knee arthroplasty improved medio-lateral instability in mid-flexion range. Journal of Orthopaedics. 14. 201-206. 10.1016 7. Grieco, Trevor F., et al. “In Vivo Kinematic Comparison of a Bicruciate Stabilized Total Knee Arthroplasty and the Normal Knee Using Fluoroscopy.” The Journal of Arthroplasty, 2017, doi:10.1016/j.arth.2017.09.035.8. Iriuchishima, Takanori, and Keinosuke Ryu. “A Comparison of Rollback Ratio between Bicruciate Substituting Total Knee Arthroplasty and Oxford Unicompartmental Knee Arthroplasty.” The Journal of Knee Surgery, 2017, doi:10.1055/s-0037-1604445. 9. Data on file with Smith & Nephew.

 

SOURCE Smith & Nephew

Related Links

http://www.smith-nephew.com

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Stryker Launches Next Generation Trident® II Acetabular System

March 7, 2018 OrthoSpineNews

MAHWAH, N.J., March 6, 2018 /PRNewswire/ — Stryker’s Joint Replacement Division today announced the commercial launch of its Trident® II Acetabular System, featuring Trident II Tritanium, at the 2018 Academy Meeting. Trident II Tritanium combines the reproducibility of Stryker’s proprietary AMagine™ additive manufactured Tritanium® In-Growth Technology and SOMA-verification process with the precision of Mako Robotic-Arm Assisted Surgery which enables surgeons to have a more predictable surgical experience.

Building on Stryker’s Trident brand legacy and successful clinical performance2-6, the design of Trident II Tritanium features a slim wall, enabled by additive manufacturing, that allows for large femoral head size options7 and optimal poly thickness to potentially aid in greater range of motion8, joint stability8, and lower risk of dislocation9. Its Tritanium surface is designed to mimic the complex, highly porous characteristics of cancellous bone10 to help promote long-term biologic fixation.

Additionally, Trident II shells maintain Stryker’s Innerchange™ Locking Mechanism, giving surgeons intraoperative flexibility to choose from clinically proven11-13 bearing options including: Modular Dual Mobility (MDM), X3 precisely engineered polyethylene or Trident constrained liners.

“I have trusted the clinical performance of Trident for many years, and I’m thrilled with the latest evolution of Stryker’s portfolio of acetabular implants,” said Walter B. Beaver, Jr., MD, a board-certified orthopaedic surgeon at OrthoCarolina. “With Trident II Tritanium, Stryker uses cutting-edge 3D-printing technology to uniquely address biological fixation and hip stability, which ultimately enhances my surgical experience.”14

“We’re excited to see implant design and innovative technology converge to bring important new products to market which will ultimately help make healthcare better,” said Stuart Simpson, President of Stryker’s Joint Replacement Division. “This System highlights our Trident II Tritanium shell, bringing together our leading additive manufacturing expertise, SOMA-design process and Mako Robotic-Arm Assisted Surgery System.”

Stryker’s AMagine™ Institute, its additive manufacturing innovation center in Cork, Ireland, is the largest orthopaedic implant additive manufacturing facility in the world. The company began investigating additive manufacturing technology in 2001 with academic research institutions and has since developed a state-of-the-art production process: AMagine. This latest advancement in joint replacement technology expands Stryker’s additive manufacturing implant footprint across multiple orthopaedic applications, including hip, knee and spine.

The Trident II Tritanium Acetabular System received initial 510(k) market clearance from the U.S. Food and Drug Administration in October 2016 and Trident II Tritanium Clusterhole was available through a limited market release in 2017. The full Trident II Acetabular System launching in 2018 offers five shell options: three in Tritanium (Clusterhole, Multihole or Solidback) and two Hydroxyapatite (Hemi Clusterhole or PSL Clusterhole) surfaces.

More than 2.5 million people are living with a hip replacement in the United States, and demand is expected to further increase due to an aging baby boomer population, higher rates of arthritis treatment and increasing demands for improved mobility15.

Stryker will showcase its latest technologies, including the Trident II Acetabular System, at the Academy meeting in New Orleans (booth #2451) from March 6-10, 2018.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.  More information is available at www.stryker.com.

1 Domb B, Redmond J, Louis S, Alden K, Daley R, LaReau J, et al. Accuracy of component positioning in 1980 total hip arthroplasties: a comparative analysis by surgical technique and mode of guidance. The Journal of Arthoplasty. 30(2015)22082218.
2 Australian Orthopaedic Association. National Joint Replacement Registry. Annual Report. AOA; 2017.
3 UK National Joint Registry, 2017 Report.
4 Naziri Q, et al. Excellent results of primary THA using a highly porous titanium cup. Orthopedics. 2013;36(4):390-394.
5 Ramappa M, et al. Early results of a new highly porous modular acetabular cup in revision arthroplasty. Hip Int.2009;19(3):239-244.
6 Capello WN, et. al. Arc-deposited hydroxyapatite-coated cups: results at four to seven years. Clin Orthop Relat Res. 2005;441:305-312.
7 Internal memo: Market Analysis of Poly Bearing Options – Trident II Versus Competitors. October 18, 2017.
8 Burroughs B, et al. Range of motion and stability in total hip arthroplasty with 28-, 32-, 38- and 44-mm Femoral Head Sizes In Vitro Study. J Arthroplasty. 2005;20(1):11-19.
9 Berry DJ, et al. Effect of femoral head diameter and operative approach on risk of dislocation after primary total hip arthroplasty. J Bone Joint Sur Am. 2005;87(11): 2456-2463.
10 Stryker R&D Technical Memo: Comparison of Tritanium Porous Surface to Cancellous Bone. A0027625
11 D’Antonio J, et al. Second-generation annealed highly crosslinked polyethylene has low wear at mean seven year follow-up. Surgical Technology International. 2014;25:219-26.
12 Jauregui J, et al. Dual mobility cups: an effective prosthesis in revision total hip arthroplasties for preventing dislocations. Hip Int. 2016 Jan-Feb;26(1):57-61.
13 Su E, et al. The role of constrained liners in total hip arthroplasty. Clin Orthop. 2004;420:122-129.
14 Dr. Beaver is a paid consultant of Stryker Orthopaedics. The opinions expressed by Dr. Beaver are those of Dr. Beaver and not necessarily those of Stryker. Individual experiences may vary.
15 Kremers, HM, Larson, DR, Crowson, CS, et al. Prevalence of total hip and knee replacement in the United States. J Bone Joint Sur Am. 2015;97:1386-97.

SOURCE Stryker

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New ATTUNE® Revision Knee System from DePuy Synthes Utilizes Proprietary Technologies to Address Broad Range of Complex Primary and Revision Procedures

March 7, 2018 OrthoSpineNews

NEW ORLEANS, March 6, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announced the US launch of the ATTUNE® Revision Knee System, to complement the ATTUNE Primary Knee System and provide surgeons with a comprehensive solution for knee replacement. The ATTUNE Revision Knee System is being introduced at the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in New Orleans, LA.

While knee replacement is widely recognized as one of the most common and successful surgical procedures, approximately five percent of patients will require a revision surgery 10 years after the initial procedure 1,2 for a variety of reasons.  Revision surgeries can create complexities particularly in cases where large bone defects present reconstruction and fixation challenges. The ATTUNE Revision Knee System aims to address some of those challenges through improved kinematics, fixation and patient fit. With both fixed-bearing and rotating platform options, it is one of the most comprehensive revision knee systems available on the market today.

“The ATTUNE Revision Knee System provides the implant options I need to treat a variety of patient anatomies including more metaphyseal sleeve sizes, offset adaptors, stems and fixation choices,” said Dr. Douglas Dennis***, Orthopaedic Surgeon, Denver, CO. “The ATTUNE Revision Knee System incorporates the advantages of the ATTUNE Primary Knee System such as AOX™ Polyethylene, enhanced locking mechanisms and improved kinematics via the ATTUNE GRADIUS™ Curve condylar geometry.”

In a large, multi-center study, the ATTUNE Primary Knee System demonstrated improved outcomes across a broad range of Patient Reported Outcome Measures (PROMs) compared to certain existing knee brands at one-year minimum follow-up.3 The same technologies that helped deliver these outcomes are also incorporated in the ATTUNE Revision Knee System, helping to address overall patient satisfaction.

“The ATTUNE Revision Knee System introduces a new chapter in the ATTUNE Knee story,” said Rajit Kamal, Vice President and Global Platform Leader, Knees, DePuy Synthes. “With six years of successful clinical history and more than 575,000 ATTUNE Primary Knees implanted worldwide, the new ATTUNE Revision Knee System allows us to bring proprietary technologies of the ATTUNE Knee System to more patients around the world.”

The ATTUNE Revision Knee System is designed to work in harmony with the patient’s anatomy to deliver stability in motion during activities such as stair ascent or descent, walking uphill or downhill or getting up from a chair through:

  • ATTUNE GRADIUS Curve is designed to address the unnatural sliding of the femur on the tibia, to provide smooth motion and stability during everyday activities
  • GLIDERIGHT™ Articulation is designed to enable the ATTUNE Knee design to more accurately replicate the normal patello-femoral kinematics of the native knee

The ATTUNE Revision Knee System is now available in the US. For more information, please click here.

About the Johnson & Johnson Medical Devices Companies

The Johnson & Johnson Medical Devices Companies** have been working to make surgery better for more than a century. With substantial breadth and depth in surgical and orthopaedic technologies and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

***Dr. Douglas Dennis is a consultant to DePuy Synthes Joint Reconstruction.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the launch of a new product, the ATTUNE® Revision Knee System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including under the captions “Item 1A. Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1M. Khan, K. Osman, G. Green, F. S. Haddah (2016). The epidemiology of failure in total knee arthroplasty. The Bone & Joint Journal, 98-B (1 Suppl A), 105-12.
2Sharkey, Peter F., et al. “Why are total knee arthroplasties failing today – has anything changed after 10 years?” The Journal of Arthroplasty 29.9 (2014) 1774-1778.
3Hamilton W.G., Brenkel, I., Clatworthy, M., Dwyer, K., Himden, S., Lesko, J., Kantor, S.:  Early Outcomes with a New Primary TKA System vs. Contemporary TKA: Interim Results of Two Worldwide, Multi-Center Prospective Studies.  AAOS, San Diego, California, March 14-18, 2017, Poster 106. Other implants tested: SIGMA Knee (DePuy), NexGen® (Zimmer), Triathlon® (Stryker).

© DePuy Synthes 2018. All rights reserved.

DSUS/JRC/0218/2584

SOURCE DePuy Synthes

Photo: DePuy Synthes ATTUNE Revision Knee System / Courtesy of DePuy Synthes

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Corin Group Launches Trinity™ Dual Mobility System for Hip Replacement at AAOS 2018 Annual Meeting

March 6, 2018 OrthoSpineNews

NEW ORLEANS, March 6, 2018 /PRNewswire/ — Corin, a global orthopaedic manufacturer and leader in functional implant positioning, today announced the launch of the Trinity™ Dual Mobility System featuring new implant technology designed to improve range of motion and reduce the risk for instability and dislocation after primary or revision hip replacement. The announcement was made here at the American Academy of Orthopaedic Surgeons (AAOS) 2018 Annual Meeting.

The system is designed for use with Corin’s Optimized Positioning System (OPS™), an innovative technology that helps surgeons determine the best positioning and orientation of a hip implant based on a dynamic preoperative functional assessment and analysis of each patient.

“Dual mobility systems have emerged to better address instability and dislocation after total hip replacement,” said orthopaedic surgeon Douglas Dennis, MD* of Colorado Joint Replacement in Denver. “The Trinity Dual Mobility System, when used with OPS technology, may go even further in addressing these issues by helping surgeons achieve optimal functional implant positioning, which has a significant impact on patient outcomes.”

The Trinity Dual Mobility System is a modular acetabular system that puts two articulating surfaces in the same joint space to provide patients with increased stability, multi-directional movement and a greater range of motion compared to conventional hip replacement.

The system is manufactured using Corin’s ECIMA™ polyethylene to help reduce the risk of in-vivo oxidation. Its proprietary design allows for a self-centering of the polyethylene liner during normal gait cycles, which reduces load and eliminates the risk of impingement between stem and polyethylene. Also, surgeons have the ability to orient the liner and decide the location of the elevated portion of the lip for an increase in jump height and greater range of motion.

“Dual mobility and optimized functional positioning is a powerful combination that will help me better tailor the operation to the patient and improve outcomes,”  said Stephen Raterman, MD,* an orthopedic surgeon at Florida Hospital in Tampa.

“We continue to respond to the needs of orthopaedic surgeons and their patients with clinically-proven procedural solutions that may help improve outcomes and increase patient satisfaction,” said Paul Berman, President, Corin USA.

About Corin Group

Corin is a European orthopaedic manufacturer based in the UK that markets its products throughout the world.

Corin is committed to:

…improving patient satisfaction with personalized technologies that optimize our clinically proven joint replacements
…delivering a personal approach to our customers, combining the spirit of our local companies with the strength of our global, integrated organization
…empowering and rewarding our global talented teams to deliver excellence to our customers

For further information about Corin, please visit www.coringroup.com.

*Paid consultant to Corin

This news release contains forward-looking statements. These statements appear in a number of places in this news release and include statements regarding our intentions, beliefs or current expectations, concerning, among other things, our results of operations, turnover, financial condition, liquidity, prospects, growth, strategies, new products, the level of new launches and the markets in which we operate. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ markedly from those in the forward-looking statements as a result of various factors. We undertake no obligation publicly to revise any forward-looking statements, except as may be required by law.

SOURCE Corin

 

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