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Study Shows Patients with MicroPort’s Medial-Pivot Knee Are More Likely to Forget They’ve Had a Joint Replacement

Posted On January 30, 2018 By OrthoSpineNews In Recon, Top Stories /  

January 30, 2018

ARLINGTON, Tenn.–(BUSINESS WIRE)–MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting edge joint replacement implants designed to help patients achieve full function faster, announced that The Journal of Arthroplasty has published a retrospective, comparative study that evaluated patient satisfaction after total knee arthroplasty (TKA) using the MicroPort Orthopedics’ MicroPort Orthopedics’ Evolution® Medial-Pivot (MP) Knee System. The study showed that patients who underwent the MP-TKA scored significantly better on the Forgotten Joint Score (FJS) than those who underwent the PS-TKA, particularly with regard to deep knee flexion and stability of the prosthesis.

“The goal of TKA surgery is to provide a joint replacement that functions as closely as possible to a normal knee and I believe that this study further validates the superiority of the medial-pivot design over traditional designs with regard to patient outcomes,” says David Backstein, MD, MEd, FRCSC, Head of Orthopaedic Surgery at Mount Sinai Hospital in Toronto, Ontario. “MicroPort’s medial-pivot features an insert designed to promote medial stability and lateral mobility and a femoral component with constant radii of curvature, resulting in greater stability and kinematics that closely replicate the natural motion of the knee.”

The article titled, “A Retrospective Comparison of a Medial Pivot and Posterior-Stabilized Total Knee Arthroplasty with Respect to Patient-Reported and Radiographic Outcomes,” was authored by Drs. David Samy and David Backstein from the Granovsky Gluskin Division of Orthopaedics at University of Toronto. A total of 164 patients, 76 in the MP-TKA group and 88 in the PS-TKA group, were evaluated at one-year follow-up using the FJS, a recently developed, validated measure of patient satisfaction after TKA. The FJS score is based on a 12-item questionnaire related to patients’ ability to forget their artificial joint in everyday life. To date, this study is the first to compare an MP-TKA and a PS-TKA using the FJS as a primary outcome measure.

Studies show that around 20 percent of patients are not satisfied with the outcome of their total knee replacement as a result of residual pain and functional issues that can often attributed to implant design1. Based on the results of this study as well as previous studies showing 95% patient satisfaction and 98.8% survivorship at 17 years, it is clear that the unique design of the MP-TKA can deliver reproducible outcomes that drive patient satisfaction2. Furthermore, it is the only medial-pivot system on the market with a clinically-proven 20-year history.

About MicroPort Orthopedics
Established in January 2014, MicroPort Orthopedics Inc. is a multinational producer of orthopedic products and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative orthopedic reconstructive products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japan, Latin America, and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/.

About MicroPort Scientific
MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 20 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com.

Forward-Looking Statements
Some information contained on this website contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

Sources:

1. Thambiah, Matthew Dhanaraj et al. “Patient Satisfaction after Total Knee Arthroplasty: An Asian Perspective.” Singapore Medical Journal 56.5 (2015): 259–263.
2. Macheras, George A. et al. “A long term clinical outcome of the Medial Pivot Knee Arthroplasty System.” The Knee 24 (2017): 447-453.

Contacts

LaVoie HealthScience
Sharon Correia, 617-412-8779
scorreia@lavoiehealthscience.com

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New Study on Total Hip Arthroplasty (THA) Outcomes with Anterior Approach Show Less Reported Pain, Fewer Narcotics and Better Hip Function in the First 90 Days

Posted On January 29, 2018 By OrthoSpineNews In Recon /  

WARSAW, Ind., Jan. 29, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies, today announced the first systematic review of prospective studies comparing postoperative outcomes through 90 days of Anterior Approach versus Posterior Approach in primary total hip arthroplasty (THA). The paper, published in The Journal of Arthroplasty, concludes that the Anterior Approach can provide a significant increase in hip function and reduction in pain and narcotics usage compared to Posterior Approach. In addition, the study showed no statistical differences in complication rates between the Anterior Approach and Posterior Approach through 90 days.

Previous comparative reviews of Anterior Approach versus Posterior Approach have predominantly relied on data from retrospective studies. For this meta-analysis, a total of 13 prospective comparative studies (including 7 randomized studies) published between 2006 and 2017 of more than 1,000 patients treated with Anterior Approach or Posterior Approach were included. Focused on perioperative outcomes, the meta-analysis attempted to address each component of the Comprehensive Care for Joint Replacement (CJR) model, which includes complication rate, patient satisfaction, and pain management over a 90-day period. The research was performed by Drs. Friedrich Boettner, Joseph S. Gondusky, and Atul F. Kamath** and well-known meta-analyst Dr. Larry E. Miller. Co-authors of the paper included Samir Bhattacharyya, PhD, MS, MSc, U.S. Head for Health Economics and Market Access (HEMA) DePuy Synthes and Dr. John Wright, Medical Leader DePuy Synthes.

“Our goal with this research was to rigorously evaluate outcomes of Anterior Approach and Posterior Approach from the highest quality prospective studies performed to date,” said lead author Dr. Miller. “We found that THA using the Anterior Approach provided clinically important benefits to patients compared to Posterior Approach over 90 days follow-up.”

The move toward the Anterior Approach is increasing as seen in a 2016 American Association of Hip and Knee Surgeons (AAHKS) survey where 34 percent of surgeons reported they were performing the Anterior Approach compared to 26 percent in a 2015 AAHKS survey. In an effort to gather additional data on this trend, DePuy Synthes, which funded this study, sought to understand the short-term benefits of the Anterior Approach as surgeons look for options in treating their patients. DePuy Synthes has spent more than a decade supporting healthcare providers who are interested in adding the Anterior Approach to their practices through professional education and training, and bringing enabling technologies to market.

“While the Posterior Approach is still the most widely used technique worldwide, we see growing interest in the Anterior Approach,” said Bhattacharyya. “This study builds on the mounting evidence that the Anterior Approach supports the goals of improving outcomes, optimizing the patient experience and reducing the overall cost of care.”

The study, “Does Surgical Approach Affect Outcomes in Total Hip Arthroplasty Through 90 Days of Follow-Up? A Systematic Review with Meta-Analysis,” is available online and will appear mid-2018 in the Journal of Arthroplasty.

About DePuy Synthes

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

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

**Drs. Friedrich Boettner, Joseph S. Gondusky, and Atul F. Kamath are consultants to DePuy Synthes Joint Reconstruction.

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

©DePuy Synthes 2018. All rights reserved.

DSUS/JRC/0118/2539

SOURCE DePuy Synthes

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http://www.depuysynthes.com

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AANA, VirtaMed Collaboration to Set New Standards for Arthroscopy Training

Posted On January 26, 2018 By OrthoSpineNews In Recon, Top Stories /  

SCHLIEREN, Switzerland and ROSEMONT, Illinois, Jan. 25, 2018 /PRNewswire/ — The Arthroscopy Association of North America (AANA) and VirtaMed have signed a two-year collaboration agreement making VirtaMed the preferred and exclusive partner for virtual reality simulation training. AANA and VirtaMed will work together to advance and improve the training of arthroscopic surgery skills and standards for proficiency-based training curricula by leveraging the latest virtual reality simulation technology and AANA’s expertise in Arthroscopic Surgery education.

The most immediate result of the contract, signed in January 2018, is that the Orthopedic Learning Center (OLC) in Rosemont, IL, will be equipped with VirtaMed ArthroS™ simulators for knee, shoulder and hip arthroscopy training, as well as FAST basic skills training. “We are excited about the opportunity to add high-fidelity simulation into our selection of educational tools. VirtaMed’s top-notch virtual reality simulators are a perfect match to the new OLC with upgraded facilities and state-of-the-art technologies,” says AANA President Robert E. Hunter, M.D.

“We have assessed all virtual reality arthroscopy simulators on the market, and VirtaMed was clearly the best fit to partner with AANA,” says AANA CEO Laura Downes, CAE. “The combination of lifelike anatomic models, high-fidelity graphics and original tools adapted for simulation make the VirtaMed ArthroS™ the closest thing to real surgery.”

AANA and VirtaMed will create new content for the simulator in all its disciplines, as well as a learning curriculum that fully leverages competency-based simulation training and assessment. The two organizations will begin with creating curriculums and proficiency exams shortly after they have collected data from course participants as well as faculty and the more experienced members of AANA early this year.

VirtaMed simulators enable proficiency-based learning as well as skills assessment. VirtaMed and AANA want to use these tools to create standards and best practices for arthroscopic training and assessment across the United States. “Our goal is to improve patient care by advancing education in arthroscopy, and we want to ensure all arthroscopic surgeons have access to high-quality skills training and continuous education. Working with VirtaMed’s first-rate simulators, experienced developers and dedicated education specialists will help us reach that goal,” explains AANA Learning Center Committee Chair, Joseph C. Tauro, M.D.

“We are honored to have been selected as the preferred and exclusive partner by such an influential organization,” says Rick Hoedt, General Manager at VirtaMed Inc. “With the various medtech customers and other societies we have as partners, it is further proof that our product and services lead the market in realism and that VirtaMed really is the go-to partner for surgical simulation. We share the same goals as AANA regarding education and training and are excited to join forces officially to enhance arthroscopy education. We’re also looking forward to working together with residency programs and simulation centers around the country and world to implement the new standard and to share best practices and standardization for improving patient safety.”

About AANA

The Arthroscopy Association of North America (AANA) is an international professional society of more than 4,000 orthopaedic surgeons and other medical professionals who are committed to advancing the art and science of arthroscopy and minimally invasive surgery through education, skills assessment and advocacy.  Our vision is be a global leader in arthroscopy and advancing minimally invasive surgical education, advocacy and skills assessment to improve patient care.

About VirtaMed

VirtaMed is the world leader in high-fidelity virtual reality simulators for instructional training of minimally invasive diagnostic and therapeutic interventions in orthopedics, urology and women’s health. VirtaMed also creates customized simulators for medical associations and medical device companies using original instruments and anatomic models for realistic feedback.

Contact:

AANA
Arthroscopy Association of North America
9400 West Higgins Road, Suite 200
Rosemont, IL 60018, United States
www.aana.org

Christine Nogal
Director of Marketing and Member Services
christinen@aana.org
Tel. +1(847)993-2063

VIRTAMED
VirtaMed AG
Rütistrasse 12
8952 Schlieren, Zurich, Switzerland

VirtaMed Inc.
16144 Churchview Drive
Lithia, FL 33547, USA
www.virtamed.com

Angina Herrmann
Head of Marketing
angina.herrmann@virtamed.com
Tel. +41-44-542-91-20

SOURCE VirtaMed

Related Links

http://www.virtamed.com

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Additional US Patents Issued to Catalyst OrthoScience, Inc. for Its Stemless Shoulder Arthroplasty Technology

Posted On January 19, 2018 By OrthoSpineNews In Recon, Regulatory, Top Stories /  

NAPLES, Fla., Jan. 19, 2018 /PRNewswire/ — Catalyst OrthoScience, Inc. has been granted four new patents by the United States Patent and Trademark Office for technologies incorporated in the CSR™ Total Shoulder Replacement System.  The Catalyst CSR™ Total Shoulder System is a new canal-sparing, anatomic shoulder arthroplasty system that provides consistently reproducible shoulder joint restoration with an humeral implant that is smaller, more anatomically-shaped, and less invasive than traditional shoulder replacement surgery.

U.S. Patent Number

Title

Patent Issue Date

9,814,588

Glenoid Arthroplasty with Multi-directional Fixation

November 14, 2017

9,814,587

Humeral Arthroplasty

November 14, 2017

9,814,471

Glenoid Arthroplasty with Offset Reamers

November 14, 2017

9,775,716

Glenoid Arthroplasty

October 3, 2107

These patents expand the portfolio of Catalyst intellectual property related to the Company’s proprietary glenoid and humeral implant designs and instrumentation. “The granting of these patents endorses the extent of our technology and provides Catalyst with further protection for its product offerings in the shoulder replacement market,” said Bob Kaufman, CEO of Catalyst OrthoScience. “We have built a solid intellectual property portfolio and will continue to work to extend the depth and breadth of that protection.”

With core technology driven by surgeon and patient need, Catalyst has been able to draw a loyal following of orthopedic surgeons since receiving FDA clearance for the CSR™ total shoulder replacement solution last year. “Catalyst’s core technology is truly innovative, as evidenced by not only the growing patent portfolio, but also by the growing number of high caliber shoulder specialists who have embraced Catalyst as an important part of their clinical offering,” said Rod Allen, Catalyst’s Senior Vice President of Sales and Marketing.

Catalyst OrthoScience was founded in 2014 by orthopedic surgeon Steven Goldberg, M.D. who realized, based on his own experience as a fellowship-trained shoulder specialist, that improvements were needed to make shoulder replacement surgery less invasive and to give patients a more normal feeling shoulder after surgery.  “It feels great to be granted these patents,” said Dr. Goldberg. “I’m still amazed at how much our team has accomplished in such a short timeframe, and now patients are seeing the benefit.”

About Catalyst OrthoScience Inc.

Headquartered in Naples, FL, Catalyst OrthoScience develops and markets innovative medical device solutions that make orthopedic surgery less invasive and more efficient for both surgeons and patients.

The company’s first offering is the Catalyst CSR Shoulder System. The Catalyst CSR is a single-tray total shoulder arthroplasty system containing a non-spherical humeral implant for consistent anatomic joint line restoration and specialized glenoid instrumentation for a less invasive approach that preserves the natural anatomy and removes less of the patient’s bone.

Catalyst OrthoScience’s products are marketed under a portfolio of brands including Catalyst OrthoScience® and Catalyst CSR™. For additional information on the Company, please visit  http://www.catalystortho.com.

SOURCE Catalyst OrthoScience, Inc.

Related Links

http://www.catalystortho.com

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Novel Method of Isolating Infecting Organisms after Joint Replacement

Posted On January 19, 2018 By OrthoSpineNews In Recon /  

PHILADELPHIA, Jan. 19, 2018 /PRNewswire/ — Joint replacement surgery carries the risk of developing an infection in the replaced joint, which can lead to a so-called revision or re-do of the joint replacement. However, current diagnostic practices can fail to detect bacteria in 30-50 percent of clinical cases, complicating or delaying appropriate treatment. Thomas Jefferson University researchers have found that genomic analysis using next generation sequencing (NGS), can identify infecting organisms in over 80 percent of cases of infected joint replacement that had previously escaped detection. The research was published January 17th 2018 in the Journal of Bone and Joint Surgery.

“This method can help detect pathogens that we would otherwise miss using standard approaches, namely culture,” said senior author Javad Parvizi, MD, Vice Chairman of Research and Professor of Orthopedic Surgery at the Rothman Institute at Thomas Jefferson University. “The study has revealed unexpected pathogens and let us to select more appropriate and effective treatments for patients.”

In order to test the ability to isolate infective organisms, Dr. Parvizi and colleagues prospectively enrolled patients undergoing a revision joint replacement over a 9-month period in 2016, and assessed for organisms identified using traditional method: culture, side by side with NGS.

The results showed that NGS identified organisms in 89 percent of infected cases versus 61 percent with culture. Furthermore, NGS was able to detect the pathogen in 81 percent of the cases that were negative for pathogens by the standard culture method, and which would have been missed otherwise.

One patient, whose case was described in a separate paper in Arthroplasty Today, reported to the emergency department with an infected joint replacement. Although standard culture was unable to identify the pathogen, NGS diagnostic tests resulted in an unexpected finding: The infection was caused by Streptococcus canis, an organism found in dogs. Further questioning of the patient confirmed that he had been scratched by his dog a few days prior to the joint infection. Once the pathogen was known, the patient could be switched to more effective antibiotics and recovered well.

“The fact that we can use this technology to detect organisms in culture-negative patients with an infected prosthesis may be significant, and could help us provide targeted treatment for these patients,” said co-author Karan Goswami, MD, a research fellow and PhD candidate affiliated with the Rothman Institute at Jefferson. “However, further study is required to validate our findings in larger numbers and determine the significance of NGS signal on treatment outcomes. A multicenter trial is underway to explore this question.”

The American Academy of Microbiologists (AAM) recently published a report supporting the use of NGS, stating, “…NGS has the potential to dramatically revolutionize the clinical microbiological laboratory by replacing current time-consuming techniques with a single all-inclusive diagnostic test.”

“Because of its promising role in diagnosing patients with periprosthetic joint infection, we have already begun to use the genomic test at our institution to isolate organisms in patients with suspected joint infection. NGS has provided critical information for the management of cases of periprosthetic joint infection at our institution, and we work closely with our microbiology colleagues to optimize treatment for these patients” said Dr. Parvizi.

Dr. Parvizi has ownership interest in MicroGenDX, the laboratory that provided next generation sequencing of samples in this study. No other disclosures were reported.

Article references:
M Tarabichi, et al., “Diagnosis of Periprosthetic Joint Infection: The Potential of Next-Generation Sequencing” the Journal of Bone and Joint Surgery, DOI: 10.2106/JBJS.17.00434 , 2018.

M Tarabichi, et al., “Diagnosis of Streptococcus canis periprosthetic joint infection: the utility of next-generation sequencing,” Arthroplasty Today, DOI:  10.1016/j.artd.2017.08.005 2017.

SOURCE Thomas Jefferson University Hospital

Related Links

http://www.jeffersonhealth.org

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Smith & Nephew’s Episode of Care Assurance Program (eCAP) reduces hospital readmission by 97% following total joint replacement surgery

Posted On January 18, 2018 By OrthoSpineNews In Recon, Top Stories /  

LONDON, Jan. 18, 2018 /PRNewswire/ — Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, today announces results showing a 97.3% decrease in readmission rates for joint arthroplasties (TJA) conducted under its Episode of Care Assurance Program (eCAP).

Working with Provider PPI, eCAP combines Smith & Nephew’s leading hip and knee implants with its PICO™ Negative Pressure Wound Therapy and ACTICOAT™ Flex 7 Antimicrobial Barrier Dressings. These products are applied post-surgery; PICO may help protect the incision by reducing seroma and hematoma fluid collections, reducing edema and lateral tension and improving perfusion.1-5 ACTICOAT Flex 7, which contains Nanocrystalline Silver, provides an effective barrier to microbial contamination to help deter surgical site infections.6

Over the past 14 months 1,380 TJAs have been conducted under the eCAP program with only two readmissions, a readmission rate of only 0.145% as compared to published rates of 5.3% or more.7

“As healthcare systems move from fee for service to pay for value, healthcare providers are increasingly responsible for the episode of care for the patient,” said Glenn Warner, President Smith & Nephew US. “eCAP can help enable providers to reduce costly readmissions after TJA by adding class-leading wound care products to help manage surgical incisions. We are proud to support our customers with innovative programs that deliver improved care in a large-scale, real-world setting.”

Smith & Nephew worked with Provider PPI, a group purchasing organization, to implement this program at Provider PPI’s client facilities in late 2016 with positive results, and is now serving 16 facilities across the US.

“Adding PICO and ACTICOAT products from Smith & Nephew to our TJA cases has been a great win for our health system clients and their patients,” said Paul Gallagher, Vice President, Provider PPI. “I am extremely pleased to see our readmission rate drop to nearly zero. In Smith & Nephew we’ve worked with a comprehensive product solutions partner that’s willing to stand behind its product portfolio.”

References

  1. Lumb H. Bacterial barrier testing (wet-wet) of PICO™ dressing with a 7 day test duration against S. marcescens.
  2. Wilkes RP, et al. Closed incision management with negative pressure wound therapy (CIM): Biomechanics. Surg Innov 2011.
  3. Karlakki S, et al. Negative Pressure Wound Therapy for management of the surgical incision in Orthopedic surgery. A review of evidence and mechanisms for an emerging indication. Bone Joint Res 2013; 2: 276-284.
  4. Canonico S, et al. Therapeutic possibilities with portable NPWT. Initial multidisciplinary observations with the negative pressure device. Acta Vulnol 2012; 10: 57-66.
  5. Selvaggi F, et al. New advances in Negative Pressure Wound Therapy (NPWT) for surgical wounds of patients affected with Crohn’s Disease. Surg Tech Int 2014; XXIV: 83- 89.
  6. Burrell et al. Efficacy of Silver-Coated Dressing as Bacterial Barriers in a Rodent Burn Sepsis Model, WOUNDS 1999; 11(4):64-71.
  7. Unplanned Readmission After Total Joint Arthroplasty: Rates, Reasons, And Risk Factors – The Journal Of Bone & Joint Surgery – jbjs.org – Volume 95-A – Number 20 October 16, 2013.

    For detailed product information, including indications for use, contraindications, effects, precautions and warnings, please consult each product’s Instructions for Use (IFU) prior to use.

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 2016 were almost $4.7 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE: SNN)

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.

SOURCE Smith & Nephew

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OrthAlign Announces Steven Haas MD, MPH, To Join Executive Surgeon Council Advisory Board

Posted On January 11, 2018 By OrthoSpineNews In Recon /  

Aliso Viejo, CA, Jan. 10, 2018 (GLOBE NEWSWIRE) — OrthAlign, Inc., a leading provider of orthopedic surgical navigation solutions, announced today that Dr. Steven Haas, Chief of the Knee Service at Hospital for Special Surgery in New York, NY, has joined the company’s Executive Surgeon Council (“ESC”) advisory board.

The ESC works closely with OrthAlign’s management team and product development group, bringing innovative products to market built upon proprietary, sensor-based surgical navigation technologies. The company’s flagship product, KneeAlign®, uses instrument-mounted sensor navigation to provide real-time guidance during primary total knee replacement procedures. OrthAlign launched UniAlign™ in early 2017, bringing the accuracy and consistency of KneeAlign to partial knee replacement surgery, opening opportunities for customers to bring impactful computer navigation into surgery centers.

“We are so pleased to have Dr. Haas join our very talented and engaged board of surgeon advisors, and to bring with him his wealth of experience and history of innovation in this space,” commented Eric B. Timko, Chairman and CEO of OrthAlign. “As we continue to expand our platform of indications, we look forward to evolving KneeAlign and building a suite of applications that make OrthAlign’s technologies the go-to solution for their ease of use, economics, and clinical results.”

“I am excited to join OrthAlign’s outstanding clinical and management teams as they continue to expand and more broadly apply their proven sensor technology,” said Dr. Steven Haas. “OrthAlign has innovative products, and I look forward to working with them as they expand their platform.”

Dr. Haas speaks nationally and internationally on hip and knee topics, and has contributed more than 90 publications into orthopedic literature. He is well known for development of ground-breaking surgical technique and instrumentation for performing minimally invasive knee replacement; along with development of high performance knee replacement systems. Dr. Haas received his education and training at Harvard, Cornell and the University of Rochester.  

ORTHALIGN, INC.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit www.orthalign.com or contact Adam Simone (asimone@orthalign.com).

Attachments:

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/070ff4f7-3771-4d0f-a87d-d457737c24c1

Adam Simone
OrthAlign
asimone@orthalign.com
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Stryker announces nomination of two new Directors, Sheri S. McCoy and Rajeev Suri

Posted On January 8, 2018 By OrthoSpineNews In Recon, Spine, Top Stories /  

By GlobeNewswire,  January 08, 2018

Kalamazoo, Michigan – January 8, 2018 – Stryker Corporation (NYSE:SYK) announced that Sherilyn (Sheri) S. McCoy and Rajeev Suri have been nominated for election to the Company’s Board of Directors at Stryker’s 2018 Annual Meeting of Shareholders, which is expected to be held on May 2, 2018.  Their successful elections would bring the total size of the Company’s Board to ten members.

Ms. McCoy brings a wealth of healthcare and consumer experience gained during a 30-year career at Johnson & Johnson that included leadership of large medical device, pharmaceutical and consumer businesses.  She is currently Chief Executive Officer of Avon Products, a personal care products company. She has held her current position for five years, and has announced that she will be retiring on March 31, 2018. She is also a member of the Board of Directors of AstraZeneca, a global, science-led biopharmaceutical company.

Mr. Suri is President and Chief Executive Officer of Nokia, a leading global technology company. Mr. Suri has deep technology experience spanning nearly 30 years, most of which have been in leadership roles at Nokia. He has served in his current role at Nokia since 2014 and has engineered a transformation of the company through significant portfolio adjustments, such as the acquisition of Alcatel-Lucent.

“We are excited about the potential to add Sheri and Rajeev to our Board,” said Kevin A. Lobo, Chairman and Chief Executive Officer. “They will bring new perspectives and complementary skills, in addition to rich experiences leading large organizations.  They also both share a passion for healthcare and helping Stryker achieve its mission.”

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

Important Additional Information and Where You Can Find It

The Company, its directors and certain of its executive officers may be deemed to be participants in a solicitation of proxies from the Company’s shareholders at its 2018 Annual Meeting of Shareholders in connection with the director nominations disclosed above. Information regarding the Company’s directors and executive officers and their respective interests in the Company, by security holdings or otherwise, is set forth in the Company’s Definitive Proxy Statement for its 2017 Annual Meeting of Shareholders, filed with the Securities and Exchange Commission (the “SEC”) on March 20, 2017, and reports filed by the Company and ownership forms filed by the directors and executive officers with the SEC. The Company will furnish its Definitive Proxy Statement for its 2018 Annual Meeting of Shareholders to shareholders entitled to vote at the meeting and will file a copy with the SEC. The Company urges its shareholders to carefully read the Definitive Proxy Statement for its 2018 Annual Meeting of Shareholders, and any other relevant documents filed by the Company with the SEC, when available because they will contain important information. Shareholders may obtain free copies of the materials referenced above at www.sec.gov or www.stryker.com.

Contacts

For investor inquiries please contact:

Katherine A. Owen, Stryker Corporation, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:

Yin Becker, Stryker Corporation, 269-385-2600 or yin.becker@stryker.com

This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Stryker Corporation via Globenewswire

This article appears in: News Headlines

Referenced Stocks: SYK

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ConforMIS announces results published in the Journal of Knee Surgery showing 100% of patients treated with iTotal CR achieve mechanical alignment in target range of +/- 3%

Posted On January 5, 2018 By OrthoSpineNews In Recon, Top Stories /  

BILLERICA, Mass., Jan. 04, 2018 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit each patient’s unique anatomy, today announced the publication of a prospective study in The Journal of Knee Surgery, a peer-reviewed orthopedic journal, on December 14, 2017. The study investigated the ability of the iTotal CR Knee Replacement System restoring coronal plane mechanical axis alignment in a patient’s leg.

The study, which was independently performed by Dr. Gary Levengood at Sports Medicine South in Lawrenceville, Georgia, examined 63 consecutive patients he operated on using the ConforMIS iTotal CR implant system and ConforMIS iJig patient-specific instrumentation.  Results in each of the cases were verified using computer-assisted surgery (CAS).  According to the study results, perfect neutral coronal mechanical alignment of 0° was achieved in 84% of patients, with the remaining 16% of patients within +/-2° of neutral.  The patients had an average pre-operative deformity of 5.57° (range 12° valgus to 15°varus), and a post-operative average of 0.18° (range 0-2°) (p<0.0001).  Additionally, while 40 of the 63 patients had pre-operative extension deficits (the inability to fully extend the leg), no patients had postoperative extension deficits.

According to the study, neutral mechanical limb alignment, or alignment within +/- 3°, has previously been linked to better survivorship in TKA, while poor alignment has been linked to higher rates of implant failure. This study’s findings are consistent with those of a previous published study by Ivie et.al. from the Journal of Arthroplasty in 2014, which concluded that the ConforMIS iTotal was 1.8 times more likely to achieve a neutral mechanical alignment as compared to standard off-the-shelf knees.

Based on a review of the published literature, the authors reported that the results observed with the ConforMIS iTotal CR patient-specific, custom-made total knee implant with patient-specific instrumentation were found to be more consistently accurate than previous reports on patient-specific cutting guides used with standard off-the-shelf implants.  The authors noted that, according to the literature, patient-specific cutting guides used with standard off-the-shelf implants resulted in a high percentage of cases with an overall error in mechanical axis alignment greater than a threshold of 3 degrees.  The authors of the study suggest several key differences that may have contributed to the greater accuracy of the iTotal system with its iJig instrumentation compared with the published literature, including the use of a full set of ConforMIS patient-specific jigs with the ConforMIS custom-made implant, and the ability to maintain native medial and lateral offsets of the femur.

“As a surgeon, one of the most important goals to me with any knee replacement, is to achieve a neutral mechanical limb alignment. The inherent variability noted in the literature when using patient-specific jigs with an off-the-shelf implant, where the mechanical alignment too often fell outside of the +/- 3° acceptable range, was the impetus in studying this metric as I began to use this iTotal technology,” said Dr Levengood. “As our data shows, we were able to achieve precise alignment, with absolutely no outliers. Prior to using the ConforMIS iTotal CR, I utilized computer navigation to achieve a reproducible alignment; however, this added substantial time to my procedures and required surgical placement of tracking pins in each patient’s femur and tibia during the operation.  With the iTotal, I am provided a complete operative plan, from the CT scan each patient gets prior to surgery.  Based on these results, I have full confidence in the system to deliver consistent and improved surgical outcomes.”

“This independent study provides compelling new data demonstrating the accuracy of utilizing ConforMIS iJig instrumentation, with its built-in mechanical axis alignment and image guidance, in combination with our individually designed, patient-specific implants,” said Mark Augusti, Chief Executive Officer and President of ConforMIS.  “Importantly, it is consistent with earlier published results.  One of the drawbacks of patient-specific cutting guides when used with standard off-the-shelf implants that are not patient-specific has been the inability to consistently achieve neutral mechanical alignment. Dr. Levengood’s data demonstrate that the ConforMIS iTotal CR system does not share this problem.  This study adds enlightening data and analysis to the growing body of evidence that ConforMIS iJig Instrumentation, when used in conjunction with ConforMIS individually designed, patient-specific iTotal implants, provides superior results compared to other patient-specific instrumentation used with off-the-shelf implants.”

ConforMIS did not provide any economic support for this study.  Dr. Levengood previously has served as an advisor to ConforMIS.

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy.  ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital.  In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.  ConforMIS owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com.

Cautionary Statement Regarding Forward-Looking Statements

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

CONTACT:

Kelly Wakelee
kwakelee@berrypr.com
(212)-253-8241

Investor Contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/728a786b-f59f-4fb5-947c-5e772c9ea94f

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0a97a95b-0207-4472-8c47-59d8a3b3b3ba

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/cb3cb524-e1b7-4e82-a02a-4d4dadbc0177

 

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AngelMD Investor Group Closes Funding Round in Articulus Bio, LLC

Posted On January 4, 2018 By OrthoSpineNews In Recon /  

SEATTLE (PRWEB) JANUARY 02, 2018

AngelMD, a platform that connects medial startups with doctors that provide guidance and investors that provide funding, today announced that its group of physician and investor members has completed a funding round for Articulus Bio, LLC. Articulus Bio is a seed-stage orthopedic medical device company focused on total ankle replacement (TAR). The (patent-pending) Articulus Bio technology takes a unique engineering approach toward solving the problems behind the majority of total joint replacement failures.

While total joint replacement surgeries are seen as a rousing success in the world of orthopedics, they are not without their own issues. Approximately one million hip and knee replacement procedures are performed each year and as many as 50,000 of these cases will likely fail within 10 years. Ankle joint failure rates are considerably more prevalent than the hip and knee, and some ankle devices may have failure rates as high as 40 percent within five to ten years.

The first area of focus for Articulus Bio is to address the wear debris issue — either metal on metal or metal on plastic — caused by friction occurring at the articulating faces of joint surfaces. These wear particles circulate through the body and often cause an immunological response known as osteolysis. The debris “eats away” where the implant junction interfaces with the body, causing a loosening of the implant that ultimately leads to the need for a revision surgery.

“It has been a privilege to collaborate with AngelMD on advancing our Tendonoid™ Web Joint technology,” said Adam Rubenstein, CEO of Articulus Bio. “Our mission is to improve outcomes and quality of life for total joint replacement patients. That requires access to capital, but for us, it’s just as essential to engage the intellectual and technical horsepower of the orthopedic surgeon community to help guide our development. AngelMD played an invaluable role in facilitating these pivotal relationships for us while assisting raising the capital we needed.”

While the Articulus Bio team remains focused on the development of their TAR product, the company has a parallel goal of deploying their platform-based Tendonoid™ Web Joint System across a host of large and small joint sites. The technology utilizes a novel configuration of the previously FDA approved Ultra High Molecular Weight Polyethylene (UHMWPE) biomaterial spun into the Tendonoid Web Joint System structure. The Tendonoid Web Joint System is designed to reduce/eliminate friction/grinding at the articulating joint faces that are observed in prior generations of devices. When the friction/grinding is reduced/eliminated, so too is the wear debris.

“In conversations with physicians and industry experts focused on Total Ankle Replacements, the feedback on the design of this new generation of TAR shows potential for a substantial leap forward in improving patient outcomes and reducing complication,” said Mark Mescher, Sr. Vice President of Professional Relations for AngelMD.

The team is raising capital in order to address specific seed-stage milestones that, on the other side of completion, will inject material value into the company. First they will capture performance data of the Tendonoid™ sub-assembly components. Second, they will prepare and submit a Q-Sub meeting package to FDA and receive regulatory pathway guidance from the agency. Finally, they will continue to build out their intellectual property portfolio.

The goal of Articulus Bio, as the future takes shape, is to take what the company learns from their TAR cases and apply it to many other large and small joints throughout the body. This should allow for total joint replacement surgeries, without the risk of wear debris, to become as commonplace as those performed on hips.

About AngelMD 
AngelMD is an investment and networking platform connecting innovative medical startups, physicians, investors, and industry partners. Leading physicians from all over the US have joined AngelMD to help source, evaluate and advise companies in biotechnology, medical device, and healthcare technology. For more information, visit http://www.angelmd.co.

About Articulus Bio, LLC 
Articulus Bio, LLC is a seed-stage orthopedic medical device company focused on total ankle replacement (TAR). The (patent-pending) Articulus Bio technology takes a unique engineering approach toward solving the problems behind the majority of total joint replacement failures.

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