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December 5, 2018 OrthoSpineNews

DALLASDecember 5, 2018 /PRNewswire/ —

FX Shoulder USA, Inc. will begin in December 2018 the FDA approved Investigational Device Exemption (IDE) clinical study of the Easytech Reversed stemless, a shoulder prosthesis, with its first implantation scheduled for December.

Easytech Reversed Stemless is an innovative shoulder arthroplasty implant that will be under clinical study with (9) sites and (12) surgeons across the U.S. participating. Building on the current success in France (home of FX Shoulder USA’sparent company, FX Solutions), where over 800 Easytech Stemless Reversed prostheses have been successfully implanted, FX Shoulder USA is slated to enroll patients at two (2) investigational sites in December and continue enrollment with additional sites beginning in January 2019.

“The Easytech Reversed may be exactly what the U.S. market is in need of, and a reversed stemless prosthesis could potentially be the future of shoulder arthroplasty,” said Baptiste Martin, CEO of FX Shoulder USA. “We are excited to begin our clinical study and enthusiastic to see the results with each successive case throughout. There is a lot of excitement among the surgeon investigators for Easytech Reversed,” he continued. In Europe, as per the article in Med Device Online dated April 11, 2018, stemless implants are projected to surpass stemmed implants by 2025.

Founded in 2011, FX Solutions has developed a large, unique and innovative range of prosthetic shoulder products, which include the Easytech Reversed Stemless. FX Solutions is now the second largest player in the French market, with more than 3,000 prostheses sold in 2018.

FX Shoulder USA, based in Dallas, Texas, is the direct provider of FX Solutions shoulder replacement devices in the U.S. FX Shoulder USA was founded in January 2018 and focuses exclusively on shoulder arthroplasty with a growing distribution network.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements, are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; and risks related to the development of Stemless Reversed shoulder prostheses, including regulatory approvals, mandates, oversight and other requirements. In this press release, forward looking statements include those concerning the development of the Stemless Reversed shoulder prosthesis, its safety and efficacy profile, its potential to benefit patients and our ability to make it available to those patients.  We disclaim any intention or duty to update forward-looking statements made in this press release.

http://www.fxshoulder.com

info@fxshoulder.com

SOURCE FX Shoulder USA

(Logo: https://mma.prnewswire.com/media/794130/FX_Shoulder_USA_Logo.jpg )

(Photo: https://mma.prnewswire.com/media/794131/FX_Shoulder.jpg )


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November 30, 2018 OrthoSpineNews

November 30, 2018

DUBLIN–(BUSINESS WIRE)–The “Global Hip & Knee Reconstruction Devices Market Analysis & Trends – Industry Forecast to 2027” report has been added to ResearchAndMarkets.com’s offering.

The Global Hip & Knee Reconstruction Devices Market is poised to grow strong during the forecast period 2017 to 2027.

Some of the prominent trends that the market is witnessing include rising gap between hospital costs and reimbursements, computer-assisted total hip replacement surgery is one of the hottest revolutions and latest technological developments of hip & knee reconstruction devices.

This industry report analyzes the market estimates and forecasts of all the given segments on global as well as regional levels presented in the research scope. The study provides historical market data for 2015, 2016 revenue estimations are presented for 2017 and forecasts from 2018 till 2027.

The study focuses on market trends, leading players, supply chain trends, technological innovations, key developments, and future strategies. With comprehensive market assessment across the major geographies such as North America, Europe, Asia Pacific, Middle East, Latin America and Rest of the world the report is a valuable asset for the existing players, new entrants and the future investors.

The study presents detailed market analysis with inputs derived from industry professionals across the value chain. A special focus has been made on 23 countries such as U.S., Canada, Mexico, U.K., Germany, Spain, France, Italy, China, Brazil, Saudi Arabia, South Africa, etc.

The market data is gathered from extensive primary interviews and secondary research. The market size is calculated based on the revenue generated through sales from all the given segments and sub segments in the research scope. The market sizing analysis includes both top-down and bottom-up approaches for data validation and accuracy measures.

Report Highlights

  • The report provides a detailed analysis on current and future market trends to identify the investment opportunities
  • Market forecasts till 2027, using estimated market values as the base numbers
  • Key market trends across the business segments, Regions and Countries
  • Key developments and strategies observed in the market
  • Market Dynamics such as Drivers, Restraints, Opportunities and other trends
  • In-depth company profiles of key players and upcoming prominent players
  • Growth prospects among the emerging nations through 2027
  • Market opportunities and recommendations for new investments

Key Topics Covered

1 Market Outline

1.1 Research Methodology

1.1.1 Research Approach & Sources

1.2 Market Trends

1.3 Regulatory Factors

1.4 Product Analysis

1.5 Strategic Benchmarking

1.6 Opportunity Analysis

2 Executive Summary

3 Market Overview

3.1 Current Trends

3.1.1 Rising gap between hospital costs and reimbursements

3.1.2 Computer-assisted total hip replacement surgery is one of the hottest revolutions

3.1.3 Latest Technological Developments of Hip & Knee Reconstruction Devices

3.1.4 Growth Opportunities/Investment Opportunities

3.2 Drivers

3.3 Constraints

3.4 Industry Attractiveness

3.4.1 Bargaining power of suppliers

3.4.2 Bargaining power of buyers

3.4.3 Threat of substitutes

3.4.4 Threat of new entrants

3.4.5 Competitive rivalry

4 Hip & Knee Reconstruction Devices Market, By Product

4.1 Knee Reconstruction Devices

4.1.1 Partial Knee Reconstruction Devices

4.1.2 Primary Cemented Knee Reconstruction Devices

4.1.3 Revision Knee Reconstruction Devices

4.1.4 Primary Knee Reconstruction Devices

4.1.5 Primary Cementless Knee Reconstruction Devices

4.2 Hip Reconstruction Devices

4.2.1 Partial Hip Reconstruction Devices

4.2.2 Hip Resurfacing Devices

4.2.3 Primary Hip Reconstruction Devices

4.2.4 Revision Hip Reconstruction Devices

5 Hip & Knee Reconstruction Devices Market, By Geography

5.1 North America

5.2 Europe

5.3 Asia Pacific

5.4 Middle East

5.5 Latin America

5.6 Rest of the World (RoW)

6 Key Player Activities

6.1 Acquisitions & Mergers

6.2 Agreements, Partnerships, Collaborations and Joint Ventures

6.3 Product Launch & Expansions

6.4 Other Activities

7 Leading Companies

7.1 Stryker Corporation

7.2 Corentec

7.3 Zimmer Biomet

7.4 Smith & Nephew PLC

7.5 Arthrex, Inc.

7.6 United Orthopedics Corporation

7.7 Baumer S.A.

7.8 Beijing Chunlizhengda Medical Instruments Co. Ltd.

7.9 DJO Global

7.10 Exactech, Inc.

7.11 Tornier, Inc

7.12 Allegra Orthopaedics Limited

7.13 Corin Group PLC

7.14 Japan MDM, Inc.

7.15 DePuy Synthes

For more information about this report visit https://www.researchandmarkets.com/research/2rknvs/global_hip_and?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Orthopedic Devices


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November 30, 2018 OrthoSpineNews

UDINE, ItalyNovember 30, 2018 /PRNewswire/ —

LimaCorporate is pleased to announce the launch of the SMR TT Hybrid Glenoid, the latest addition to the SMR Shoulder System.

The SMR Shoulder System is a total shoulder replacement designed to provide surgeons a wide range of options to address the different patients’ pathologies. There have been over 150,000 implants performed worldwide.

SMR TT Hybrid Glenoid is the first glenoid component with hybrid fixation convertible from anatomic to reverse. Being part of the SMR Shoulder System, SMR TT Hybrid Glenoid has been designed to provide an innovative solution for glenoid replacement allowing for proper soft tissues management thanks to an optimal range of sizes, mismatch options, and a reliable fixation supported by a combination of polyethylene and Trabecular Titanium, LimaCorporate’s proprietary 3D printed technology.

After a limited release phase, the SMR TT Hybrid Glenoid has been launched in the USA and New Zealand. SMR TT Hybrid Glenoid has also received the CE mark and will be officially launched next year in February during the Paris Shoulder Course.

This important accomplishment has been reached thanks to the contribution of a panel of experienced shoulder surgeons coming from all over the world.

This year, the SMR Shoulder System has been awarded by the Orthopaedic Data Evaluation Panel (ODEP) in the UK, two ratings (ODEP ratings can be found on odep.org.uk) a 10A rating for the SMR Reverse with Uncemented Fixation (Metal Glenosphere / Polyethylene Liner Combination), making it the only Reverse with a 10A rating available on the market and a 5A ODEP Rating – SMR Reverse HP with Uncemented Fixation (Polyethylene Glenosphere / Metal Liner Combination).

“We are very excited about the introduction of this innovative device on the market, which allows LimaCorporate to further complete the Shoulder portfolio, keeping its outstanding clinical heritage and approaching a new fixation philosophy,” said Luigi Ferrari, CEO 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.

(Logo: https://mma.prnewswire.com/media/637371/Lima_Corporate_Logo.jpg )


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November 21, 2018 OrthoSpineNews

PLAINSBORO, N.J., Nov. 20, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, today announced one of the first surgeries with the Integra® XT Revision Total Ankle Replacement System.

“Integra’s new total ankle revision system is designed to provide surgeons with stable tibial fixation through a narrow, finned tibia. I appreciate the anterior surgical approach, which is mindful of the blood supply,” said Dr. Christopher Ritter, a foot and ankle surgeon in Buffalo, New York. “I have performed several revision procedures with the XT Revision System and found that it is easy to implant and provides stable fixation. My patients are happy with their early outcomes.”

The Integra XT Revision Total Ankle Replacement System is one of the first FDA cleared devices indicated for revision ankle arthroplasty only and can be used to revise any commercially available primary total ankle replacement system. Key implant features include:

  • An augmented posterior sloped talus which addresses subsidence by rebuilding posterior talar height.
  • An anatomic design that mimics the natural kinematics of the ankle, designed to promote a more normal gait and better overall function post-operatively.

“The launch of the Integra XT Revision Total Ankle Replacement System represents Integra’s commitment to further advance ankle arthroplasty solutions,” said Robert T. Davis, Jr., corporate vice president and president, Orthopedics and Tissue Technologies. “Many of our surgeons have expressed their excitement for the XT system and our approach for ankle revision surgery. With this addition to our ankle reconstruction portfolio, Integra now offers comprehensive care for end-stage ankle arthritis patients.”

The Integra XT Revision Total Ankle Replacement System was developed in partnership with five world leading foot and ankle surgeons – Dr. Michel Bonnin, (Lyon, France), Dr. Chris Coetzee (Eagan, Minnesota), Dr. Jean Alain Colombier (Toulouse, France), Thierry Judet, PhD (Paris, France), and Dr. Mark Myerson (Baltimore, Maryland).  It is available in the U.S. through Integra’s Extremity Orthopedics sales team.

About Integra XT Revision Total Ankle Replacement System
Integra XT is indicated as a total ankle replacement in revision surgeries only for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.  Components are intended for cemented use only.

About Integra
Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

CONTACT: Integra LifeSciences Holdings Corporation

Investors
Sravan Emany
(609) 936-2488
sravan.emany@integralife.com

Michael Beaulieu
609-750-2827
michael.beaulieu@integralife.com

Media 
Laurene Isip
609-750-7984
laurene.isip@integralife.com


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November 19, 2018 OrthoSpineNews

ROSEMONT, Ill.Nov. 16, 2018 /PRNewswire/ — A new review article published in the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) finds arthroscopic (joint replacement or reconstruction) management could be a promising option for young, active patients diagnosed with GHOA.

Primary glenohumeral osteoarthritis (GHOA) is a common type of painful and debilitating shoulder osteoarthritis (OA). Shoulder OA leads to upper body dysfunction in over 20 million Americans. People with GHOA may have trouble throwing, swimming and lifting their arms to do everyday tasks. They often have pain centered in the back of their shoulder. As it progresses, shoulder arthritis pain may interrupt sleep. This condition can be especially frustrating for younger, active patients.

“Total shoulder replacement is not ideal for young, high-demand patients with GHOA,” explains Peter J. Millett, MD, lead author of the study and orthopaedic surgeon at the Steadman Clinic. “Instead patients under 50 years old or select active patients up to age 65 with advanced GHOA who haven’t experienced adequate relief from nonsurgical treatment may experience the greatest benefit from arthroscopic management.”

Over the last 15 years, Dr. Millett has been working on an arthroscopic approach to treat GHOA that preserves the shoulder joint, decreases pain and improves function. This approach, the Comprehensive Arthroscopic Management (CAM) procedure, is also now being successfully utilized by other orthopaedic shoulder specialists for some patients to treat shoulder osteoarthritis.

Outcomes for patients with advanced symptomatic GHOA who underwent CAM procedures include:

  • Significantly improved ability to complete daily activities and reduced pain and instability as reported by both patients and doctors (known as the American Shoulder and Elbow Surgeons Shoulder Score (ASES));
  • Significant rates of preventing total shoulder arthroplasty (TSA) at one, two, three and five years following CAM procedures; and,
  • Median patient satisfaction rate of nine out of 10 five years after CAM procedures among patients who did not need TSA.

Osteoarthritis is the most frequent cause of disability in the United States. Cartilage breaks down, and the body’s healing process can ruin the smooth joint surfaces needed for typical movement. Related inflammation also limits motion. Doctors have multiple surgical and non-surgical treatment options for osteoarthritis. Physical therapy, home exercise, cortisone injections, and anti-inflammatory medications such as ibuprofen may offer relief for osteoarthritis, but the scientific literature supporting these approaches is limited. Despite this, Dr. Millet notes that most doctors will try one or more of these methods before suggesting surgery.

If nonsurgical efforts fail, removing damaged cartilage or bone (debridement) or arthroplasty are potential next steps. However, each of these approaches have potential downsides, including long recovery times, surgical risks and acceleration of the arthritis with more pain, stiffness and dysfunction. With arthroplasty, additional risks related to the artificial joint may include pain, dysfunction and wearing out of implants over time.

In search of a solution to address these shortcomings, orthopaedic surgeons have identified new combinations of treatments that preserve joints and delay or avoid arthroplasty. Dr. Millet and his colleagues combined new and existing procedures to treat this specific arthritis.

“The CAM procedure is a minimally invasive surgery that removes mechanical irritants from the joint, reshapes the humerus to make it round again and also to decrease any impingement on the adjacent nerves,” says Dr. Millett. “The overall goal is to achieve a synergistic benefit with pain relief and functional restoration, without burning bridges for future surgeries, all while delaying joint replacement or perhaps even avoiding it altogether.”

Advantages of arthroscopic management as compared to total shoulder arthroplasty include delaying or avoiding arthroplasty, preserving the joint, and preserving future treatment options. Disadvantages of CAM include that the procedures are technically demanding, long-term outcomes remain unknown, and that there is no guarantee a patient will not need arthroplasty in the future.

“The human and economic costs of shoulder arthritis are substantial and conventional treatment has significant shortcomings. This new, more tailored approach is potentially good news for GHOA sufferers. “Long-term data of patients who have undergone the CAM procedure show promising, but not perfect, results,” Dr. Millett concludes.

The full study is available at: https://bit.ly/2DdneyI
More information about arthritis of the shoulder is at OrthoInfo

More information about the AAOS
 and JAAOS
Follow the AAOS on FacebookTwitter and Instagram

Follow the conversation about JAAOS on Twitter

Disclosures
From the Steadman Philippon Research Institute (Dr. Millett and Dr. Fritz), and the Steadman Clinic, Steadman Philippon Research Institute (Dr. Frangiamore and Dr. Mannava), Vail, CO. Dr. Millett or an immediate family member has received royalties from Arthrex and MedBridge; serves as a paid consultant to Arthrex; has stock or stock options held in Game Ready and VuMedi; and has received research or institutional support from Arthrex, Össur, Siemens, and Smith & Nephew. Dr. Fritz or an immediate family member has received research or institutional support from Arthrex, Össur, Smith & Nephew, and Vail Valley Medical Center. Dr. Mannava or an immediate family member serves as a board member, owner, officer, or committee member of the Arthroscopy Association of North America. Neither Dr. Frangiamore nor any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this article. JAAOS – Journal of the American Academy of Orthopaedic Surgeons: November 1, 2018 – Volume 26 – Issue 21 – p 745–752
doi: 10.5435/JAAOS-D-17-00214

SOURCE American Academy of Orthopaedic Surgeons

Related Links

http://www.aaos.org


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November 16, 2018 OrthoSpineNews

MEMPHIS, Tenn., Nov. 16, 2018 /PRNewswire/ — Smith & Nephew (LSE: SN,NYSE: SNN), the global medical technology business, presented a number of compelling clinical outcomes around its flagship JOURNEY II BCS knee earlier this month at the American Association of Hip and Knee Surgeons (AAHKS). The announcement follows more than a dozen publications during the past year from various authors around the globe.1-14

In one of the largest multi-center retrospective patient cohorts ever studied, new clinical evidence represented excellent mid-term survivorship results on 2,059 patients with JOURNEY II BCS implants including:

  • About 1% of patients required major revision out to 6 years.15
  • No major or minor revision of any patient four years or more post-op.15
  • Five year revision rate that was reported as 3.6% compared to 4.1% for the cemented posterior stabilized (PS) class in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR).15
  • Statistically significantly better survivorship for patients under 55 when compared to the Australian registry class average for the same age group at 6 years. The revision rate was 3% at 5 years for males and 3.1% for females, compared to 7% for males and 6.9% for females reported by the AOANJRR for cemented PS TKAs.15

These data add to the growing body of evidence that JOURNEY II TKA delivers smoother patient recovery, improved functional outcomes, higher patient satisfaction and healthcare cost-savings when compared with conventional TKAs.1,2,6,7,9,16,17

“It is very exciting to see additional clinical validation in such a large study showing excellent patient outcomes with our JOURNEY II TKA.  For years we at Smith & Nephew have been discussing the unique benefits of JOURNEY II knees and we are now seeing regular publications highlighting the improved outcomes compared to conventional TKAs.  These better-quality outcomes are a direct benefit to our surgeon customers and most importantly to their patients,” said Skip Kiil, President of Global Orthopaedics, Smith & Nephew.

JOURNEY II TKA first launched in late 2011 and now has more than 150,000 procedures performed worldwide.18

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 ReconstructionAdvanced Wound ManagementSports 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.comfollow @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.

References:

  1. Nodzo SR, Carroll KM, Mayman DJ. The Bicruciate Substituting Knee Design and Initial Experience. Tech Orthop.2018;33:37-41.
  2. Takubo A, Ryu K, Iriuchishima T, Tokuhashi Y. Comparison of muscle recovery following bicruciate substituting versus posterior stabilized total knee arthroplasty in an Asian population. J Knee Surg. 2017;30:725–729.
  3. Snyder M, Sympson A, Gregg J, Levit A. A comparison of patient reported outcomes between total knee arthroplasty patients receiving the Journey II bi-cruciate stabilizing knee system and total hip arthroplasty patients. Ortop Travmatol Protez. 2018;3:5-10.
  4. Christen B, Kopjar B. Second-generation bi-cruciate stabilized total knee system has a lower reoperation and revision rate than its predecessor. Arch Orthop Trauma Surg. 2018;138(11):1591-1599. https://doi: 10.1007/s00402-018-3019-5.
  5. Evangelista PJ, Laster SK, Lenz NM, Sheth NP, Schwarzkopf R. A Computer Model of Mid-Flexion Instability in a Balanced Total Knee Arthroplasty. J Arthroplasty. 2018;33(7S):S265-S269.
  6. Grieco TF, Sharma A, Dessinger GM, Cates HE, Komistek RD. In Vivo Kinematic Comparison of a Bicruciate Stabilized Total Knee Arthroplasty and the Normal Knee Using Fluoroscopy. The Journal of Arthroplasty. 2018;33(2):565-571.
  7. Kaneko T, Kono N, Mochizuki Y, Hada M, Toyoda S, Musha Y. Bi-cruciate substituting total knee arthroplasty improved medio-lateral instability in mid-flexion range. J Orthop. 2017;14(1):201-206.
  8. Harris AI, Luo TD, Lang JE, Kopjar B. Short-term safety and effectiveness of a second-generation motion-guided total knee system. Arthroplasty today. 2018;4(2):240-243.
  9. Iriuchishima T, Ryu K. A Comparison of Rollback Ratio between Bicruciate Substituting Total Knee Arthroplasty and Oxford Unicompartmental Knee Arthroplasty. J Knee Surgery. 2018;31(6):568-572.
  10. Murakami K, Hamai S, Okazaki K, et al. Knee kinematics in bi-cruciate stabilized total knee arthroplasty during squatting and stair-climbing activities. J Orthop. 2018a;15(2):650-654.
  11. Murakami K, Hamai S, Okazaki K, et al. Preoperative tibial mechanical axis orientation and articular surface design influence on the coronal joint line orientation relative to the ground during gait after total knee arthroplasties. Knee Surg Sports Traumatol Arthrosc2018b;26:3368-3376.
  12. Murakami K, Hamai S, Okazaki K, et al. In vivo kinematics of gait in posterior-stabilized and bicruciate-stabilized total knee arthroplasties using image-matching techniques. Int Orthop. 2018c;42:2573-2581.
  13. Zambianchi F, Fiacchi F, Lombari V, et al. Changes in total knee arthroplasty design affect in-vivo kinematics in a redesigned total knee system: A fluoroscopy study. Clin Biomech (Bristol, Avon). 2018;54:92-102.
  14. Lutes W and Fitch D. Comparison of functional outcomes following total knee arthroplasty with a conventional implant design or one designed to mimic natural knee kinematics. Presented at: 39th SICOT Orthopaedic World Congress; October 10-13, 2018; Montréal, Canada.
  15. Harris AI. Performance of second-generation guided motion total knee arthroplasty system: Results from the international multicenter study of over 2,000 primary TKA with up to 6 Years follow-up. Poster presented at AAHKS Annual Meeting. November 1-4 2018Dallas, Texas, USA.
  16. Mayman DJ, Patel AR, Carroll KM. Hospital Related Clinical and Economic Outcomes of a Bicruciate Knee System in Total Knee Arthroplasty Patients. Poster presented at: ISPOR Symposium; May 19-23, 2018Baltimore, Maryland, USA.
  17. Kosse NM, Heesterbeek PJC, Defoort KC, Wymenga AB, van Hellemondt GG. Minor adaptations in implant design bicruciate-substituted total knee system improve maximal flexion. Poster presented at: 2nd World Arthroplasty Congress; 19-21 April, 2018Rome, Italy.
  18. Data on file with Smith & Nephew.

SOURCE Smith & Nephew

Related Links

http://www.smith-nephew.com


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November 15, 2018 OrthoSpineNews

Dave, would you please give us a brief overview of your Orthopedic career and how you got started in the business?

Immediately following my graduation from the Business School at Arizona State University I went to work for American Hospital Supply Corporation. As I progressed through my career with AHSC, they provided excellent training in Sales, plus Sales and General Management This foundation prepared me for my subsequent career in Orthopedics,

My Orthopedic career began in 1982. I have enjoyed the privilege of being a part of four startup/early-stage companies, a global contract manufacturer for Orthopedics and Spine, and some of the major joint companies. My responsibilities have ranged from Sales and Product Management, Senior Sales & Marketing roles, and General Management. They include running the US business for a European based multinational orthopedic company, President of a Digital Imaging company focused on Orthopedic practices, and Global Sales and Customer Satisfaction Leadership for the contract manufacturing division of a Swedish conglomerate who supplied implants and instrumentation to major Orthopedic and Spine companies. Early in my orthopedic career I realized my passion was for technology-based orthopedic, early-stage companies.

My first technology based startup was Intermedics Orthopedics where we introduced a new titanium mesh ingrowth surface to orthopedics. The next endeavor was Orthologic, a bone growth stimulation company which possessed a unique and very effective waveform for the healing of delayed and non-union fractures. As Vice President of Sales & Marketing we grew the company from $0 to $30 million in three years and subsequently acquired Sutter Biomedical. I also served as the Vice President of Sales & Marketing at DonJoy. From there I was recruited by Aesculap Orthopedics to run their U.S. business. Aesculap pioneered Computerized Surgical Navigation and introduced it to America. They also introduced the first Advanced Surface Technology coated knee for patients who are allergic to Cobalt, Chrome, and Nickel. Prior to coming to Myoscience, I spent five years as the West Area Vice President for Biomet Orthopedics with responsibility over Joint Reconstruction, Trauma, Sports Medicine and Biologics. I currently serve as the Executive Vice President, Commercialization for Myoscience.

There is no question the technology Myoscience has introduced is the most exciting I have experienced in my 36 year orthopedic career.

Can you share some of the back story on Myoscience as well as a general overview of where things stand today?

Myoscience, founded in 2005, is a private-equity funded medical technology company based in the Silicon Valley. Its proprietary technology, the iovera° system, was developed as a nontoxic alternative to Botox and initially marketed in Europe.

In 2013, the iovera system was cleared by the FDA for treating peripheral nerves with cryoanalgesia to block pain. The iovera° therapy blocks pain by cryoneurolysis, which is a localized disruption of the signal-carrying members of a nerve. This is referred to as cryoanalgesia – pain relief by applying extreme cold. Physicians explain this treatment to their patients as “freezing of nerves”.

Robust, level 1 clinical studies have found the iovera therapy to be effective as:

A non-opioid nerve block, the effects of which are immediate and long-lasting for treating chronic and perioperative pain.

Since 2016, Myoscience has focused its commercialization efforts on treating chronic knee pain due to osteoarthritis and acute knee pain after total knee arthroplasty. These well-defined market segments help Myoscience establish its iovera technology as a pain management modality of choice, especially to address the opioid crisis the country in currently facing.

Can you explain a high level overview of how the technology works?

The iovera system uses centuries-old, well-established principles of cryoanalgesia. The advantage of using nitrous oxide as the cryogen is it limits the temperature range (-20C to -88C) of cold applied to the target nerve(s). This ensures that the lysis of the nerve is within the 2nd degree of nerve disruption per Sunderland’s classification, which renders this to be reversible.

The therapy is delivered through a compact, cordless and hand-held device. Pressurized liquid nitrous oxide is delivered into closed-end needles, where it is allowed to expand to gas. The phase change produces -88C at the tips of the needles. Moisture from the surrounding tissue freezes to form a small tic-tac sized ice ball at the distal end of these needles. This is sufficient to cause the desired selective lysis of the targeted nerve.

The nitrous oxide gas is vented out through the hand-held device. Therefore, no drug or chemical is delivered into the body.

There is one important distinction – cryoneurolysis by the iovera system should not be confused with cryoablation. Cryoablation is a complete and permanent damage and removal of tissue, most commonly associated with Heat Radio Frequency treatments. The effect of cryoneurolysis, on the other hand, is transient and reversible.

What is the “Why” behind the iovera system?

The opioid crisis in our country is not expected to end any time soon. More than 15% of patients continue to depend on opioids six months after TKA surgery and 40% of patients who use opioids before TKA continue to depend on these drugs several months after surgery.

Physicians and surgeons are trying to use several modalities to limit the dependence on opioids. The iovera therapy has been identified as one of those modalities.

The significant advantage of the iovera therapy over all other modalities is it is drug-free, very localized and non-systemic. It takes a physician or a PA or NP less than 30 minutes to administer it. The provider receives positive confirmation of the treatment because the iovera therapy is administered while the patient is awake.

Where would we expect to see the iovera device being used in the market place?

The safety and efficacy of the iovera technology has been well-established via robust, randomized clinical studies, especially for treating knee pain. Myoscience is currently completing another study on the knee at the Campbell Clinic in Memphis, Tennessee. The results from this study are not only encouraging, but further confirm what has already been observed. The early results were presented at a symposium during the recent AAHKS Meeting. The study results have been selected for a podium presentation by William Mihalko, MD, the Principal Investigator, at the March 2019 American Academy of Orthopedic Surgeons Meeting.

We are currently enrolling patients in a study to establish the iovera therapy’s efficacy in treating patients who undergo ACL repair/reconstruction surgery. Additionally, we plan to expand the application of the iovera therapy to treat shoulder pain and the all-too-prevalent low back pain.

Any closing thoughts or remarks as we wrap up the interview?

The iovera therapy is intended for preventing opioid addiction. The federal government and several state governments are focused on fighting the crisis after the patient is addicted to opioids. Our objective is to prevent the addiction; not fight it after the fact.

Surgeons are beginning to refuse TKA for patients if they don’t receive the iovera therapy. This is a profound statement, especially from the thought leaders in the orthopedic industry. Several surgeons have referred to technology as a “game changer.”

I appreciate the contributions of Jessica Preciado, PhD, our Director of Clinical Research & Principal Scientist and Kris Kumar, our Director, Marketing and Product Management to this article.

Myoscience’s journey has just begun. We foresee the iovera therapy as the pain management modality of choice for treating the pain and symptoms of several diseases in the coming years.

Dave, we really appreciate your time today. Congratulations on all of the success thus far and we look forward to seeing what’s in store for you and the entire team at Myoscience.


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November 14, 2018 OrthoSpineNews

SPOKANE, Wash.Nov. 13, 2018 /PRNewswire/ — Dr. David F. Scott, a leading orthopedic surgeon and researcher, is exploring new, innovative knee implant designs and surgical techniques made for custom fit total knee replacements.

The basis for this improved knee replacement performance is an anatomical approach, whereby an implant is placed in the native joint line of a patient’s knee using specific anatomic landmarks around the knee to guide the orientation of the prosthetic components in an attempt to restore the joint to its pre-arthritic position and function. This differs from the more widely used, traditional method where total knee replacements are performed with a mechanical alignment that places implants in an average position for all patients, regardless of their individual anatomy.

Dr. Scott already employs this anatomical approach in his surgical technique, a variation on a technique known as Kinematic Alignment (KA), a surgical method made popular by Dr. Stephen Howell in 2005, and has seen the benefits it provides to his patients, including improved knee function and overall patient satisfaction.

Now, Dr. Scott is building on and advancing the work done by himself, Dr. Howell, and others by helping perfect implants specifically designed for this technique — something that has the potential to shape the future of total joint replacement procedures.

While only a small fraction of surgeons use an anatomical approach for knee replacements, the technique is gaining more interest due to exposure in scientific publications and at joint replacement meetings, symposia, and educational events, of which Dr. Scott actively participates.

Dr. Scott and Dr. Howell have worked to vocalize and teach the merits of this approach through a series of learning centers, where didactic lectures are followed by cadaver surgeries. Additionally, Dr. Scott is designing instruments to aid and perform the surgical technique, as well as advising manufacturers of orthopaedic devices on the design of research protocols to compare KA to the the traditional mechanical alignment technique with the hope of providing more concrete evidence of its merits.

“Anecdotally, the single most important finding of the research surrounding the anatomical approach is that it’s possible to improve significantly the clinical outcomes after total knee arthroplasty (TKA),” says Dr. Scott. “My research shows that an anatomic approach can work very well — that a more anatomic knee implant design, coupled with an anatomic approach to the surgical procedure itself, produces the best results ever seen with TKA.”

Although more longer-term studies are needed to prove further these already stellar results, Dr. Scott feels confident that this approach is the future of knee replacement.

“This custom alignment process is where the future of knee replacements is going. Average alignments are the old school method which I believe will be phased out completely over time,” says Dr. Scott. “The research is already out there with more being done to prove the effectiveness of custom alignments every day, and we’re really happy to be leading this work.”

Dr. Scott has published and presented research extensively in the orthopaedic field, and, specifically, on the benefits of the anatomical approach to knee replacement and implant design. He recently published a paper in the May 2018 issue of the “Journal of Arthroplasty” titled “Prospective Randomized Comparison of Posterior-Stabilized Versus Condylar-Stabilized Total Knee Arthroplasty: Final Report of a Five-Year Study”; in an ongoing study titled “Medial-Pivot, Cruciate- Substituting, Post-Market Multicenter Outcomes Study,” a multi-center study comparing the results of knees implanted with the KA approach versus the results from other surgeons using the mechanical alignment approach; and in a podium presentation titled “Patient Satisfaction and Clinical Outcomes Are Better With a Medial-Stabilized Implant vs. a Posterior-Stabilized Implant” presented to the International Society for Technology in Arthroplasty in London, Englandin October of 2018.

For more of Dr. Scott’s research, visit the research section on the OSC website (https://orthospecialtyclinic.com/our-research).

About Dr. David F. Scott
Dr. Scott completed his orthopaedic residency in New York City at the Hospital for Joint Diseases. He received fellowship training in adult reconstruction at the University of Utah, where he was an adjunct assistant professor at the School of Medicine for over 5 years. He is currently a clinical instructor at the UW School of Medicine, and specializes in arthritis surgery with an emphasis on joint replacement. David F. Scott, MD is an active member of the American Association of Hip and Knee Surgeons. His practice, Orthopaedic Specialty Clinic, is based in Spokane, Washington. For more information about OSC, visit the website (https://orthospecialtyclinic.com).

Media Contact:
Geneva Randall 
204564@email4pr.com 
509-690-6085

SOURCE Dr. David F. Scott

Related Links

https://orthospecialtyclinic.com/our-research


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November 14, 2018 OrthoSpineNews

November 13, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral and knee surgery implants, is announcing a distribution agreement with privately owned KICO KNEE INNOVATION COMPANY PTY LTD (“KICO”) for the MADISON Knee prosthesis business covering the United States and other future markets.

This distribution agreement will initially cover the high-potential markets of the United States and Australia on a non-exclusive basis. KICO will then gain exclusive rights to MADISON knee prostheses once it hits the threshold of 1,000 MADISON implants in a 12-month period, as well as an option for a manufacturing license.

Ludovic Lastennet, Implanet’s Chief Executive Officer, commented: “This partnership is an endorsement of the clinical value of our proprietary MADISON technology. With over 17,000 MADISON knee prostheses implanted since 2010, mainly in France, we have demonstrated the clinical value of our implant. The data we have compiled over the past 7+ years helped us seal this partnership, which will boost our Knee division by providing it with exposure to markets where we could not envision establishing our own sales presence. This type of partnership fits with the medium-term development plan we announced in the middle of 2018. It demonstrates our ability to develop technologies to meet the highest standards in the market, which can then be rolled out either directly or via a partnership in international markets. With this distribution agreement, we will be able to target the most promising markets, such as the United States, the world’s largest worth over $4 billion1.”

“As part of my professional activities, I have implanted close to 1,500 MADISON knee prostheses, including 750 next-generation femurs. The clinical results have been highly satisfactory, the principal advantages are the conservation of the patient’s bone stock and a simple and versatile instrumentation. I was very excited to learn about the partnership between Implanet and KICO, our profession being even more oriented towards solutions allowing the personalization of care and the remote follow-up of our patients”, commented Dr. François Deprey, Orthopedic Surgeon at the Courlancy clinic in Reims, France.

Bede O’Connor, Managing Director and founder of KICO, commented: “We were very impressed by the quality and good nature of the entire Implanet team. With Brad Miles, my partner, we attended several surgeries in France last January. They have shown that the MADISON knee is well designed and has a strong clinical following. We have developed a partnership plan that integrates the MADISON implant into our customization solution. The project has been directly supported with a AUD$2.5m grant by the New South Wales Medical Devices Fund.”

Beyond the above mentioned implant customization, KICO uses a holistic approach to knee replacement, tailoring each and every case to the individual. The process is conducted over a series of stages to ensure the best possible result:

1. Use pre-operative patient profiling and shared decision making tools to help patients and their orthopeadic surgeon make great treatment choices.

2. Create and manage a patient specific prehabilitation program that is delivered both face to face and via a telemedicine platform by our experienced physiotherapy team.

3. World-class biomedical engineers create dynamic surgical plans that are truly patient specific to the knee replacement candidate. The 3D plans utilise advanced simulation and customisation technology.

4. Surgery delivered with patient specific technology for the femur, tibia and patella. This ensures accurate and precise placement of the total knee replacement components.

5. Create and manage a patient specific rehabilitation program that is delivered both face to face and via a telemedicine platform by our experienced physiotherapy team.

6. Post-operative patient monitoring that integrates with wearable sensors. Our data analytics platforms ensure that the knee replacement patient recovery is targeted and measured.

Implanet will be attending the following scientific conferences during Q4 2018:

SOFCOT in Paris from November 12 to November 15, 2018, stand F07
BSS (British Scoliosis Society) in Belfast from November 29 to November 30, 2018, stand 9
DWG in Wiesbaden (Germany) from December 6 to December 8, 2018, stand 102

About KICO KNEE INNOVATION

KICO was founded in 2014 and now maintains 45 full time staff. Head office activities are based in Sydney Australia. The Company also has offices in Austin Texas and Christchurch New Zealand. KICO holds ISO13485 certification, maintains CE certification and has regulatory approvals in the USA, New Zealand and Australia. KICO’s management team previously founded Optimized Ortho Pty Ltd, which was sold to Corin in 2014. KICO is privately owned. For further information, please visit www.kneesystems.com

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 46 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

1 Source: GBI Research database

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu


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November 13, 2018 OrthoSpineNews

YARDLEY, Penn.Nov. 12, 2018 /PRNewswire/ — Today marked the launch of the Reduce Revisions Initiative (www.reducerevisions.org), a program focused on supporting orthopedic professionals with the goal of measurably improving outcomes of total joint arthroplasty (TJA).

Total Joint Arthroplasty can dramatically improve lives by restoring mobility, reducing pain, and promoting a return to normal activities. Most of these procedures include Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). During one year in the U.S. alone, orthopedic surgeons perform more than 1 million TKA and THA procedures. According to the 2018 published estimates on total joint replacement from the American Academy of Orthopedic Surgeons, this number is expected to nearly double by 2030. Though very successful, joint replacement occasionally fails requiring revision. In the US over 100,000 patients undergo revision knee and hip replacement each year, and that number that is also expected to grow rapidly in the coming years.

“One mode of failure of joint replacement is infection. Because of the sheer number of joint replacements we do and better diagnostic modalities, the number of infected joint replacements are also likely to rise in the coming years. Infection of a prosthetic joint is a major problem for both the patient and the healthcare” shared Dr. Javad Parvizi, Professor of Orthopedic Surgery at Rothman Institute in Philadelphia and chair of the Reduce Revisions editorial board. “It’s time for us to face this issue head on, and I’m excited about the potential for the Reduce Revisions Initiative to be part of the solution by promoting best practices and sharing innovative developments in total joint replacement.”

In order to make a meaningful contribution to total joint arthroplasty patient care, Reduce Revisions will create communication channels focused on sharing information with total joint surgeons, nurses, administrators, and other key healthcare professionals in the patient care continuum. The Initiative’s Editorial Board has identified several key areas for education:

  • Infection prevention & management
  • Fixation optimization
  • Patient involvement in preventing revision surgery
  • New frontiers in TJA
  • Improving economics

Reduce Revisions also will work to accelerate research around total joint arthroplasty quality improvement and complications management. A five-member editorial board, comprised of distinguished orthopedic researchers and surgeons, is now developing forums and events that foster collaboration and sharing of surgeons’ experiences, as well as exploring ways to make ongoing learning opportunities easily accessible. Ultimately, Reduce Revisions will measure its success by the outcomes of primary total joint replacement surgery and the shift in need for revision surgery.

About Reduce Revisions
Reduce Revisions is focused on supporting orthopedic professionals through education and collaboration, with the goal of improving outcomes of total joint arthroplasty, thus reducing the need for revision surgery. The initiative is sponsored by Heraeus Medical, the inventor and exclusive manufacturer of PALACOS® bone cement products. Learn more and join the community at www.ReduceRevisions.org.

Reduce Revisions Editorial Board
ChairJavad Parvizi, MD, FRCS
Members: Antonia Chen, MD, MBA; Carlos Higuera-Rueda, MD; Bryan Springer, MD; Michael Kheir, MD; Thorsten Gehrke, MD

Contact:
Christine Horton
DevicePharm, Inc
Christineh@devicepharm.com
952-873-9030

SOURCE Reduce Revisions

Related Links

https://www.reducerevisions.org