Zimmer Biomet Announces FDA Clearance and First Surgical Case of the Persona® Trabecular Metal™ Tibia

Posted On April 16, 2018 By OrthoSpineNews In Recon, Regulatory /

WARSAW, Ind., April 16, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the completion of the first surgical case utilizing its Persona^® Trabecular Metal™ (TM) Tibia by Dr. Richard Moore, Boise, Idaho on March 20, 2018. The Persona Trabecular Metal Tibia received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2018 and CE Mark approval in April 2018. The Persona TM Tibia is an integral component of the Company’s portfolio of cementless total knee arthroplasty (TKA) solutions.

“Combined with the Persona TM Femur and the TM Patella, clearance of the Persona TM Tibia allows us to provide a fully cementless total knee solution, furthering our long-standing commitment to enhancing patient experiences and outcomes,” said Dan Williamson, Zimmer Biomet’s Group President, Joint Reconstruction. “We believe this innovative product will position us to re-establish our leadership in the fully cementless primary knee market.”

Zimmer Biomet’s proprietary TM Material is a porous biomaterial made from elemental Tantalum with structural, functional and physiological properties similar to cancellous bone.^1-3 With more than 20 years of clinical results, the Company’s TM Material has been used in over two million orthopaedic devices.

“The clearance of the Persona TM Tibia represents a significant step forward for those patients who can benefit from completely cementless total knee replacements that better integrate into the natural bone anatomy for durability, while possibly offering greater patient satisfaction,” said Dr. Moore.

The Persona TM Tibia features new drilling, sizing and insertion instrumentation that are unique to the Persona TM Tibia, while preserving all the anatomic benefits of the Persona Tibia design.^4-8 The Persona TM Tibia is another example of how the Persona System continues to redefine personalization by combining Zimmer Biomet’s 20-year porous fixation expertise with the Persona Knee family. As the Company’s most comprehensive knee system, the Persona System offers more anatomically accurate components with finer increments to personalize patient fit and restore the unique identity of every knee.

“The TM tibial tray and pegs fit beautifully to the bone. I believe the instruments for trial prep and implant placement were a clear improvement and an advantage. I also appreciate the time efficiency of using cementless implants,” concluded Dr. Moore.

Zimmer Biomet plans a limited launch of the Persona TM Tibia in the first half of this year, followed by a full commercial launch in the second half of 2018.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Bobyn, et al., Characterization of a New Porous Tantalum Biomaterial for Reconstructive Orthopaedics. 66th Annual AAOS 1999.
Zhang, et al., Interfacial Frictional Behavior: Cancellous Bone, Cortical Bone, and a Novel Porous Tantalum Biomaterial. Journal of Musculoskeletal Research. 3:4, 245-251, 1999.
Karageorgiou and Kaplan. Porosity of Biomaterial Scaffolds and Osteogenesis. Biomaterials. 26: 5474-91, 2005.
Dai, et al. Anatomical Tibial Component Design Can Increase Tibial Coverage and Rotational Alignment Accuracy: A Comparison of Six Contemporary Designs. Knee Surgery Sports Traumatology Arthroscopy 22:2911–2923; KSSTA 2014.
Indelli, et al. Relationship between Tibial Baseplate Design and Rotational Alignment Landmarks in Primary Total Knee Arthroplasty. Hindawi Publishing Corporation Arthritis. Volume 2015, Article ID 189294.
Jin, et al. How Much Does the Anatomical Tibial Component Improve the Bony Coverage in Total Knee Arthroplasty. Journal of Arthroplasty. pp. 1-5; 2017.
Mizu-uchi, et al. Anatomical Shaped Tibial Baseplate Reduced Rotational Alignment Compromise in Total Knee Arthroplasty: Clinical Evaluation with Asian Knees. ORS 2017 Annual Meeting Paper No.0110. 21.Bandi, Marc, et al. Finer Femur and Insert Increments in Total Knee Arthroplasty Facilitate Accurate Balancing and Reduce the Need for Complex Techniques. Abstract number 850; ORS 2014.
Stulberg and Goyal. Which Tibial Tray Design Achieves Maximum Coverage and Ideal Rotation: Anatomic, Symmetric, or Asymmetric? An MRI-based study. Journal of Arthroplasty. 30(10): 1839, 2015.

For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counseling information, see the package insert and www.zimmerbiomet.com.

Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. Forward-looking statements speak only as of the date they are made, and Zimmer Biomet disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

ZB-Corp

CONTACT: Media – Monica Kendrick, 574-372-4989, monica.kendrick@zimmerbiomet.com; Investors – Derek Davis, 574-372-4250, derek.davis@zimmerbiomet.com, or Barbara Goslee, 574-371-9449, barb.goslee@zimmerbiomet.com

phototake_rm_photo_of_knee_being_prepped_for_surgery.jpg

Global Knee Replacement Market Analysis 2018-2024: Key Players are Zimmer Biomet, Stryker, Smith & Nephew, Johnson & Johnson – ResearchAndMarkets.com

Posted On April 16, 2018 By OrthoSpineNews In Recon /

April 16, 2018

DUBLIN–(BUSINESS WIRE)–The “Knee Replacement Market, Global Analysis, by Products, by Regions and Companies” report has been added to ResearchAndMarkets.com’s offering.

Knee Replacement Market Globally is anticipated to exceed US$ 13 Billion by the year 2024, experiencing a significant growth over the forecast period.

Knee Replacement consists of tools or system which is used for the diagnosis and treatment of knee fracture and other knee diseases. Knee Reconstruction Devices market is expected to witness substantial growth due to increasing number of Osteoarthritis patients, Rising Geriatric Population, Rising Pool of Knee Fractures, favorable reimbursement, and technological advancements further boosts the demand for the industry over the forecast period.

Zimmer Biomet Holding Inc., Stryker Corporation, Smith & Nephew, Johnson & Johnson (Depuy Synthes), and are some of the top companies operating in the global knee replacement market; which has been studied thoroughly in the report.

Key Topics Covered:

1. Executive Summary

2. Global Knee Replacement Market

3. Market Share – Global Knee Replacement (2011 – 2024)

4. Companies Share – Knee Replacement

5. By Product – Global Knee Replacement Market

6. By Region – Global Knee Replacement Market

7. Zimmer Biomet Holdings Inc. – Companies Analysis

8. Stryker Corporation – Company Analysis

9. Smith & Nephew PLC – Company Analysis

10. Johnson & Johnson – Company Analysis

11. Growth Drivers of Knee Replacement Market

12. Challenges faced by Knee Replacement Market

For more information about this report visit https://www.researchandmarkets.com/research/bvh2l6/global_knee?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior 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

JRI Orthopaedics Acquired By Chinese Firm

Posted On April 11, 2018 By OrthoSpineNews In Recon /

11/04/2018 – Article by: CHRIS MIDDLETON

The award-winning healthcare manufacturer has been acquired by China’s leading orthopaedic implant company AK Medical for £16.7m.

The Sheffield-based company, which was wholly owned by the charity Orthopaedic Research UK (ORUK), now becomes part of one of the world’s largest 3D-printed orthopaedic implant manufacturers.

The synergy created by combining the two businesses will create a larger and stronger group within the international orthopaedic sector.

JRI Orthopaedics has worked closely with the Beijing-based AK Medical, China’s largest domestic orthopaedic implant producer, for the last three years as part of a strategic growth strategy.

After securing regulatory approval to sell its own high quality cemented, uncemented and revision hip product portfolio in China, JRI Orthopaedics signed an exclusive distribution deal with AK Medical.

It has also been sub-manufacturing AK Medical implants at its state-of-the-art Chapeltown manufacturing plant where further investment is now planned.

The acquisition will see JRI Orthopaedics continuing as an autonomous business with no change to the company’s management team or Sheffield workforce.

Jerry Agass, JRI Orthopaedics joint-managing director, said: “The JRI Board and our staff are excited by the agreement reached with AK Medical and look forward to a stronger future as a combined business.

“We have been working successfully together in the Chinese market for the last three years and there is a strong commercial fit between the two companies, both in terms of their business strategies and ethics.

“AK Medical attaches great importance and value to the specialised skills, knowledge and experience of the management and employees at JRI and this was a key attraction of the business.

“Both brands will continue but combining the two businesses will create a larger and stronger group within the international orthopaedic sector and will open up a number of joint opportunities that will benefit customers worldwide.”

READ THE REST HERE

Ortho Sales Partners Announces the Addition of Chris Lyons as Vice President of Exit Strategy

Posted On April 9, 2018 By OrthoSpineNews In Recon, Spine, Top Stories /

Ortho Sales Partners, the global leader in commercialization services for the orthopedic industry, is pleased to announce a tremendous addition to the executive team. In an effort to serve clients from inception through exit, Ortho Sales Partners has recruited Chris Lyons to serve as its Vice President of Exit Strategy. Mr. Lyons will be a vital component of any client’s project as he will help create and guide the overall strategy and work on client’s behalf during possible transaction discussions.

Mr. Lyons career began at Smith and Nephew in 1989. While at SNN, he held numerous marketing roles, driving product launches, engaging surgeons, and creating intellectual property predominantly in the companies Knee and Hip product lines. Additionally, he spent two years in the Smith and Nephew Sales Force to learn the underpinnings of what made the organization successful.

In 2005, Chris joined Medtronic Spine and Biologics, with the first three years being focused on driving growth of the International biologics business of Medtronic. The opportunity presented itself to move into the realm of Business Development where he served the past 10 years. During this time, Mr. Lyons worked with all of the executive and cross functional leadership to transact various acquisitions, minority investments, as well as license and distribution agreements. Chris was also selected to join the Board of the Southeast Medical Device Association (SEMDA) of which he remains a contributor, also serving as Chairman of the board for SEMDA for 2016.

With a highly driven, passionate, and entrepreneurial spirit, Chris is excited to be joining the ranks of Ortho Sales Partners as Vice President of Exit Strategy to assist this growing team of industry experts to influence positive commercialization and exit outcomes for Med Tech and Device companies. Chris will work closely with Venture Capital, Private Equity and other companies focused on successfully exiting. Chris can provide Strategic Guidance, Gap Analysis, M&A consultation and will help implement general strategies that help the shareholders to maximize their return during due diligence and negotiations.

About his new role, Chris Lyons said: “The power of Ortho Sales Partners is their leadership. They have developed a game changing business based on integrity to positively influence better outcomes for medical device companies, which in turn has the possibility to influence greater innovation and healthcare delivery to the market in a timely manner. I am excited to be part of this team of industry experts.”

“Chris Lyons is extremely well respected and we are thrilled that he has chosen to join our team of the industries most talented and experienced leaders. Ortho Sales Partners continues to demonstrate its commitment to excellence and our team has just gotten demonstrably stronger. We are now able to help companies successfully navigate from early commercialization through exit.” Said Kevin McGann, CEO of Ortho Sales Partners.

About Ortho Sales Partners

Ortho Sales Partners has created a unique platform to help companies in any stage commercialize their products in a very efficient way. We have worked closely with many organizations and produced results that have profoundly impacted each client’s business.

Our services are geared to meet you where you are today and help your business grow by utilizing proven industry executives that bring you an objective analysis and recommendations going forward. Our market knowledge is based on current trends and competitive analysis from industry stalwarts from some of the highest growth companies.

Ortho Sales Partners’ headquarters are in Scottsdale, Arizona but we have several offices across the US. (http://www.orthosalespartners.com).

Namal Nawana appointed Chief Executive Officer of Smith & Nephew

Posted On April 4, 2018 By OrthoSpineNews In Recon, Top Stories /

4 April 2018

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces the appointment of Namal Nawana as Chief Executive Officer. He will join the Company and be appointed to the Board as an Executive Director on 7 May 2018.

Most recently, Namal was Chief Executive Officer of medical diagnostics company Alere Inc, where he led the successful turnaround of this global business and oversaw its $5.3 billion acquisition by Abbott in 2017. He joined Alere as Chief Operating Officer in December 2012.

Prior to Alere, Namal spent more than 15 years at Johnson & Johnson, primarily in its Medical Devices & Diagnostics segment, in a number of progressively senior commercial leadership roles across markets including in the USA, Asia and Europe. In 2011 he became Worldwide President of DePuy Synthes Spine, where he oversaw a transformation programme including substantial margin improvement and the integration of Synthes following its acquisition in 2012.

Namal will succeed Olivier Bohuon, who will step down from the Board on 7 May. During his notice period, Olivier will be available in an advisory capacity to provide advice and assistance to Namal in his new role, to help ensure a smooth transition.

Roberto Quarta, Chairman of Smith & Nephew, commented:

“In Namal I am delighted that we have secured an exceptional new chief executive with a proven record within the medical device industry. He has the experience as a CEO of a major listed company in the healthcare sector, and has demonstrated that he can energise businesses to deliver better performance and greater value to shareholders. We are looking forward to him joining our Board and driving Smith & Nephew to the next level of success.”

“I would also like to thank Olivier for his service. In his seven years as chief executive, Smith & Nephew has undergone important and necessary change and he has significantly strengthened the foundations of our Company. This has delivered strong value to shareholders, almost doubling the share price and materially outperforming the FTSE100, whilst also increasing the dividend distribution by more than 100%. On behalf of the Board and all of Smith & Nephew I wish him a happy retirement and all the best for the future.”

Namal Nawana commented:

“I am passionate about the medical devices industry where I have worked all my life and it is an honour to become the new Chief Executive of Smith & Nephew, a company I greatly admire. I am most excited by its portfolio of innovation which I believe gives an excellent platform from which to drive the business forward into its next exciting chapter.”

Mr Nawana is an independent member of the Board of Hologic, Inc. No further disclosure obligations arise under paragraphs (1) to (6) of LR 9.6.13 R of the UK Listing Authority’s Listing Rules in respect of this appointment.

Remuneration

Mr Nawana will be paid in accordance with the Remuneration Policy approved by shareholders on 6 April 2017, as set out in the Annual Report:

He will be employed on our standard US executive contract.
He will receive a base salary of $1,540,000 per annum (£1,100,000 converted using average exchange rates for Q1 2018) and will be paid at that dollar amount going forward.
He will participate in the Annual Incentive Plan (cash and equity) and the Performance Share Plan. Awards for 2018 will be pro-rated to reflect time served during the year.
He will be eligible to join those US defined contribution pension plans available to our US executives: Executive Plus Plan, 401k and 401k plus savings. Collectively, the Company contributions to these plans total 21.47% of salary.
He will receive standard US Executive benefits, which are not materially different in nature or value relative to the incumbent CEO.
His notice period will be six months, with the Company required to provide 12 months.
Mr Nawana will receive no sign-on or buy-out award associated with joining the Company.

Up until his retirement from the Company on 6 November 2018, Mr Bohuon will be paid in accordance with the Company’s Remuneration Policy and the terms of his service agreement:

He will continue to receive his salary, benefits and a payment in lieu of pension during his notice period.
He will also participate in the 2018 Annual Incentive Plan for the period up until his retirement. Any Annual Incentive Plan payment, which is dependent on performance, will be determined by the Remuneration Committee in February 2019.
In accordance with the Plan Rules, on his retirement from the Company all unvested Equity Incentive Awards will vest in their entirety.
Also in accordance with the Plan Rules, the outstanding Performance Share Plan awards granted will be pro-rated for service and will, subject to the performance conditions being satisfactorily met at the end of the three-year performance period, vest on the original vesting dates on the third anniversary of the respective dates of grant. He will be required to retain any vested shares, net of tax, in relation to the 2017 award for a further two-year period after the vesting date. In light of his anticipated retirement, no Performance Share Plan award was made in 2018.

Enquiries

Investors
Ingeborg Øie	+44 (0) 20 7960 2285
Smith & Nephew

Media
Charles Reynolds	+44 (0) 20 7401 7646
Smith & Nephew
Ben Atwell / Debbie Scott	+44 (0) 20 3727 1000
FTI Consulting

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.}

Exactech Knee Research Honored with Orthopaedic Research Society’s Best Implant Poster Award

Posted On April 3, 2018 By OrthoSpineNews In Recon /

April 03, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today that its research, “Total Knee Arthroplasty Using a Contemporary Computer-Assisted Surgical System: A Review of Resection Alignment on 8,000 Clinical Cases,” received the Orthopedic Implant Section Best Poster Award at the 2018 Orthopaedic Research Society (ORS) Annual Meeting in New Orleans, La.

The study was based on a large collection of technical reports on all the total knee arthroplasty cases performed in the entire application history of ExactechGPS®, Exactech’s surgeon-controlled computer-assisted surgery for improved reproducibility and efficiency in total joint arthroplasty. The results demonstrated high accuracy and precision in resection alignment with the use of the system by users with varying levels of experience.

Two additional posters, featuring the Truliant® Knee System’s femoral and patellar designs, were recognized as poster finalists in the same category. According to Co-Author H. Morton Bertram III, MD, “Truliant’s new design has had a very positive impact. I find that I can improve coverage of the native bone with the more anatomic patella.”

“The recognition from ORS is an incredible achievement that shows our commitment to research and surgeon input to deliver a clinically engineered system that addresses surgeons’ needs for reproducibility in total knee arthroplasty,” said Vice President of Knee Marketing Joseph Pizzurro. “We are pleased to receive such a positive response to Truliant’s comprehensive platform, including its state-of-the-art ExactechGPS knee applications and anatomical implant design.”

In the shoulder and orthopedic implant categories, the Equinoxe® Shoulder System was also recognized as a finalist for two different posters. The research featured a comprehensive outcome study of nearly 1,600 patients, the analysis of which provided surgeons a new threshold to quantify outcomes after total shoulder arthroplasty; this work was also recently published in the Journal of Shoulder and Elbow Surgery.

Exactech was well represented at the meeting with a total of 23 scientific posters and presentations featuring its latest innovations for shoulder, knee, hip and biologics.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Contacts

Exactech
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication
media@exac.com

Stryker Brings The Mobility Zone™ and Joint Health Education to Houston Open

Posted On March 29, 2018 By OrthoSpineNews In Recon /

MAHWAH, N.J., March 29, 2018 /PRNewswire/ — Stryker Orthopaedics is pleased to announce its second PGA TOUR stop of 2018, its fifth consecutive year as the “Official Joint Replacement Products of the PGA TOUR® and PGA TOUR Champions,” with an appearance at the Houston Open in Humble, TX.

During the tournament, Stryker will continue its commitment to educating golf fans about the importance of joint health through an interactive experience in The Mobility Zone, featuring an Accuracy Challenge and Stryker’s Mako Technology.

As the premiere feature of The Mobility Zone, the new Accuracy Challenge will invite visitors to take a shot at surgery with a hands-on experience introducing Art H. Ritis, a life-size model that aims to provide tournament-goers a basic understanding of joint replacement surgery and Stryker’s Mako Technology.

Additionally, orthopaedic surgeons who use Mako Technology will be on-site at The Mobility Zone to discuss joint health and treatment options with fans who are experiencing joint pain or want to learn more.

“The Mobility Zone is a phenomenal opportunity for fans to stop by and learn about joint replacement with our Mako Technology,” said Stuart Simpson, President, Stryker’s Joint Replacement Division. “We are truly committed to our mission of making healthcare better, and this is a great way for us to do that.”

Continuing a relationship that began in 2015, Stryker is proud to support K9s For Warriors at tournaments throughout the year. Tournament-goers can show their support for veterans by purchasing the same hat that PGA TOUR professional and longtime brand ambassador Fred Funk wears on TOUR at The Mobility Zone. With each hat purchase, Stryker will make a donation to K9s For Warriors, the nonprofit organization dedicated to providing service canines to military veterans suffering from Post-Traumatic Stress Disability, traumatic brain injury or other military trauma as a result of military service post 9/11.

Finally, as part of Stryker’s dedication to motivating fans to stay active, Stryker will host the Health Walk at the Houston Open. The Health Walk highlights joint health and golf facts along the course to educate fans as they follow their favorite golfers.

For additional information on the Stryker Accuracy Challenge as well as K9s For Warriors involvement, please visit: www.patients.stryker.com.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.

About PGA TOUR

By showcasing golf’s greatest players, the PGA TOUR engages, inspires and positively impacts our fans, partners and communities worldwide.

The PGA TOUR co-sanctions more than 130 tournaments on the PGA TOUR, PGA TOUR Champions, Web.com Tour, PGA TOUR Latinoamérica, Mackenzie Tour-PGA TOUR Canada and PGA TOUR-China. Members on the PGA TOUR represent the world’s best players, hailing from 25 countries (84 members are from outside the United States). Worldwide, PGA TOUR tournaments are broadcast to more than 1 billion households in 226 countries and territories in 23 languages. Virtually all tournaments are organized as non-profit organizations to maximize charitable giving. In 2017, tournaments across all Tours generated a record of more than $180 million for local and national charitable organizations, bringing the all-time total to $2.65 billion.

The PGA TOUR’s web site is PGATOUR.COM, the No. 1 site in golf, and the organization is headquartered in Ponte Vedra Beach, Florida.

SOURCE Stryker Orthopaedics

Trice Medical Achieves CE Mark and Health Canada Approval for Mi-Eye 2™, Performs First Cases in Toronto and the UK

Posted On March 16, 2018 By OrthoSpineNews In Recon, Regulatory /

MALVERN, Pa., March 16, 2018 (Newswire.com) – U.S. based, Trice Medical, announced today the completion of its first successful case performed in the United Kingdom, after receiving CE (Conformité Européenne) Mark of approval in Europe for the mi-eye 2™, as well as entry into Health Canada.

Today’s case was performed by Mr. Tony Andrade, a Consultant Orthopaedic Surgeon at Circle Reading Hospital. “This is a fantastic opportunity to be able to show patients what’s going on inside their joints and talk them through it live as you see the pathology. This is something that’s been needed for a long time to aid patient’s understanding of their condition. It’s useful not just for diagnostic purposes, but it allows for the delivery of injections into the appropriate targeted area.” said Mr. Andrade.

The early success of Trice Medical’s mi-eye 2, which was launched in the U.S. in 2017, has captured the attention of medical professionals who are embracing the technology as a new diagnostic modality. After the first year of commercial launch, the mi-eye is currently being used by over 200 institutions across the states. The disposable needle embedded with a wide-angle camera lens enables physicians to diagnose joint injuries right in their clinic, and provide their patients with immediate answers to the cause of their pain.

“Truly disruptive technology always provides value by enhancing care and lowering cost. This approach to diagnosis is such a proposition.” Stated Jon J.P. Warner, MD. Chief, MGH Shoulder Service and Professor of Orthopaedic Surgery at Harvard Medical School, regarding the mi-eye 2 technology.

“Trice is proud and excited to be commercializing the mi-eye 2 into Europe and Canada. MRI and Ultrasound will always be good options for patients with sports injuries. We are thrilled to add disposable in-clinic arthroscopy to the list of available tools physicians have to be able to assess joint injuries. In many countries, the mi-eye 2 has a chance to save weeks to months of the treatment pathway to surgery AND provide a dynamic image of the joint. The is truly an example of innovation in the new world of value-based medicine,” said Mark Foster, Chief Commercialization Officer and VP of Worldwide Sales at Trice Medical.

Additionally, Dr. Anthony Miniaci of the Cleveland Clinic Canada has completed the first cases performed by a surgeon in Toronto, ON. The advent of this technology in the Canadian market has the potential to provide patients with a dramatic amount of time saved in their overall continuum of care per injury.

Today’s patient had this to say about her experience, “I had an operation back in December but was still having some knee problems. I didn’t want to go through another general anesthetic operation so Mr. Andrade recommended the mi-eye procedure would be a good option…The experience overall was fantastic, and I didn’t feel any pulling, tugging or pressure. Mr. Andrade has now identified what we need to do next for my treatment. I would definitely recommend it to others.”

About the mi-eye 2™:

Trice Medical’s mi-eye 2, is a handheld, single-use, and disposable direct visualization tool. The mi-eye 2 was specifically designed for use in the clinic setting, consisting of a single stick percutaneous, and self-blunting design which deploys an integrated camera and a light source. The procedure is performed with local anesthetic and provides patients with an alternative to traditional diagnostic modalities, such as time-consuming and often inaccurate MRIs. The mi-eye is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. mi-eye 2 is available for prescription use only.

About Trice Medical:

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, and the physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology, the mi-eye 2, that provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

Contact Trice Medical:

+1 (610) 989-8080

info@TriceMedical.com

Source: Trice Medical

Solvay’s Zeniva® PEEK enables durable all-polymer knee implant from Okani Medical Technology

Posted On March 12, 2018 By OrthoSpineNews In Recon, Top Stories /

Alpharetta, Ga., March 5, 2018 — Solvay, a leading global supplier of specialty polymers, announced that Okani Medical Technology, a China-based pioneer in artificial joint applications, has developed an all-polymer knee implant based on Solvay’s Zeniva® polyetheretherketone (PEEK). Okani’s novel ORGKnee™ implant offers a longer service life at a lower cost than traditional metallic implant systems. Solvay’s booth at AAOS 2018 will feature the ORGknee™ implant in multiple sizes.

Okani evaluated Zeniva® PEEK’s suitability for the femoral and tibial tray components of its knee implant according to ISO 14243-1:2009, which simulates normal walking behavior over 10 years. The findings, which Okani will present at the Orthopaedic Research Society (ORS) 2018 Annual Meeting next week, indicate that the ORGKnee™ implant made of Zeniva® PEEK exhibited 50 percent less wear versus a metal implant as measured by material loss over 3 million cycles.

Okani selected Zeniva® PEEK for its ORGKnee™ implant due, in part, to the material’s success in spinal implant applications. Unlike implants made of cobalt chrome or titanium alloys, those molded from Zeniva® PEEK exhibit a modulus similar to cortical bone, which can improve patient comfort, provide a more stable fixation over time and extend implant lifetime due to significantly reduced wear of the total knee-joint prosthesis.

“PEEK’s injection molding capability makes large-scale production of ORGKnee™ implants possible in a fraction of the time and cost it takes to make metal implants, which can take up to three months to manufacture, machine and polish using methods that can pose risks both to workers and the environment,” said Zhonglin Zhu, chief technology officer for Okani.

Another motivation that prompted Okani’s decision to work with Solvay was the polymer supplier’s reputation for partnering with highly innovative medical device companies.

“Okani’s implant is not only a perfect showcase for the unique properties of Zeniva® PEEK, but also for Solvay’s open innovation business model, which takes a collaborative approach to helping medical device customers foster innovation and optimize their technology,” said Jeff Hrivnak, global business manager for Healthcare at Solvay’s Specialty Polymers Business Unit.

Okani’s ORGKnee™ implant enters pre-clinical trials this April before undergoing standard clinical trials by China’s Food and Drug Administration (CFDA) in September, 2018. The company plans to commercially launch its ORGKnee™ solution in 2020 after CFDA approvals are complete.

For more information about this application and related news about specialty polymers for healthcare, please go to solvayhealthcarenews.com.

® Zeniva is a registered trademark of Solvay

™ ORGKnee is a trademark of Okani Medical Technology

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Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, ultra-high performance aromatic polymers, and high barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.

Solvay is an advanced materials and specialty chemicals company, committed to developing chemistry that address key societal challenges. Solvay innovates and partners with customers worldwide in many diverse end markets. Its products are used in planes, cars, batteries, smart and medical devices, as well as in mineral and oil and gas extraction, enhancing efficiency and sustainability. Its light-weighting materials promote cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 24,500 employees in 61 countries. Net sales were €10.1 billion in 2017, with 90% from activities where Solvay ranks among the world’s top 3 leaders, resulting in an EBITDA margin of 22%. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB – Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.

Geisinger Announces It Will Stand Behind Cost of Hip Surgery for a Lifetime

Posted On March 10, 2018 By OrthoSpineNews In Recon /

March 08, 2018

DANVILLE, Pa. & CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Once again, Geisinger is pioneering a ground-breaking new model for care in which the innovative health system has announced it will expand its ProvenCare Total Hip program even further by standing behind the costs associated with orthopaedic surgeries for a lifetime.

Geisinger collaborated with Medacta International, a global leader in orthopaedic medical devices, on a first-of-its-kind pilot program to provide a Geisinger Health Plan member who was receiving hip-replacement surgery an unlimited time frame for future surgical care and cost that may be needed. These costs will be proportionally shared between Geisinger and Medacta, including the device itself and all hospital costs, while the patient remains with Geisinger Health Plan and is treated by Geisinger providers.

“Surgeon education and mentorship is a core pillar of Medacta’s mission, with hundreds of surgeons from around the world receiving training each year through our renowned M.O.R.E. Institute and AMIS Education Program,” said Francesco Siccardi, Executive Vice President of Medacta International. “This value-based care partnership with Geisinger, our first, further underscores Medacta’s commitment to improving the patient experience while redefining the orthopaedic ‘product’ to encompass not only the implant, but also accompanying surgical technique, education and instrumentation. We are proud to go beyond implant replacement and share in the risk and overall cost of patient care, which we believe to be an unprecedented step for an orthopaedic manufacturer.”

The first patient enrolled in the pilot – an active, 53-year-old woman – underwent successful total hip replacement surgery on Monday, February 26, 2018, with plans underway to expand the program. This is the first time ever that a patient will be afforded the full range of care – both hospital care and device replacement – for future revisions at no charge when all services are delivered to Geisinger Health Plan members by Geisinger providers.

Under the country’s current reimbursement system, hospitals are often paid more when something goes wrong during surgery. Geisinger has long served as the national model for reversing this trend and a champion of delivering high quality care at lower costs to the more than 3 million patients seeking treatment every year.

“Rather than follow the prevalent fee-for-service model, Geisinger rewards value,” said Michael Suk, MD, JD, MPH, MBA chair of the Geisinger Musculoskeletal Institute and the Department of Orthopaedic Surgery. “When it comes to the hip replacement pilot program, what we’re saying to our patients is that the level of service we’ll provide will be so exemplary that if there’s a problem tomorrow or 20, 30, or 40 years from now, we’ll take care of it. Geisinger continues to drive the national dialogue on value-based orthopaedic surgery through this groundbreaking expansion of our ProvenCaremodel.”

In 2006, Geisinger transformed the health care industry by introducing its renowned ProvenCare program. This multifaceted program includes the reengineering of care using evidence-based “bundles” and adoption of a fixed per-case rate that covers preadmission, inpatient, and follow up care, including any and all complications 90 days post–procedure.

In 2014, Geisinger launched ProvenCareHip Fracture, Total Hip, Total Knee and Lumbar Spine in yet another chapter of the health system’s transformative care.

“Since introducing the ProvenCare orthopaedic protocols, we’ve witnessed a decrease in readmissions and a reduction in length-of-stay figures when it comes to total hip replacements,” said Dr. Suk. “By affixing evidenced-based protocols to all hip and knee surgeries, we are able to ensure the same high-quality care is delivered to every patient, every time. In 2018, we’re expanding our ProvenCarecommitment even further.”

About Medacta International

Medacta^® International is a world leading manufacturer of orthopaedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS^® system and total knee replacement with MyKnee^® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

About Geisinger

Geisinger is an integrated health services organization widely recognized for its early adoptions of the electronic health record and the development of innovative care delivery models such as ProvenHealth Navigator^®, ProvenCare^® and ProvenExperience^®. As one of the nation’s largest health service organizations, Geisinger serves more than 3 million residents throughout 45 counties in central, south-central and northeast Pennsylvania, and in southern New Jersey at AtlantiCare, a Malcolm Baldrige National Quality Award recipient. In 2017, the Geisinger Commonwealth School of Medicine and Geisinger Jersey Shore Hospital became the newest members of Geisinger. The physician-led system is comprised of approximately 30,000 employees, including nearly 1,600 employed physicians, 13 hospital campuses, two research centers, and a 583,000-member health plan, all of which leverage an estimated $12.7 billion positive impact on the Pennsylvania and New Jersey economies. Geisinger has repeatedly garnered national accolades for integration, quality and service. In addition to fulfilling its patient care mission, Geisinger has a long-standing commitment to medical education, research and community service. For more information, visit www.geisinger.org, or connect with us on Facebook, Instagram, LinkedIn and Twitter.

Contacts

CONTACT for Geisinger:
Wendy Wilson, 570-840-0878
WKWilson@geisinger.edu
or
CONTACT for Medacta International:
Jill Bongiorni, 516-729-2250
jill@torchcomllc.com