Health insurers look for ways to cut costs with back surgery

By JAY GREENE /August 26, 2018

  • Insurers adopt prior authorization programs to encourage alternative treatments, save money
  • Blue Cross, HAP and Priority Health have different approval criteria that continue to evolve
  • Back surgeons sometimes find it difficult to manage prior authorizations, but denial rates are low

Back surgery is one of the most overused types of surgery as well as the most common ailment that sends patients to doctors, chiropractors and physical therapists. More than $90 billion a year is spent on low-back pain alone.

On any given day, 31 million Americans experience low-back pain, and it is the leading cause of disability worldwide, according to the 2017 Global Burden of Disease study. Back pain also is one of the most common reasons for missed work.

Controlling costs is a major effort most health insurers are focusing on with patients who want back surgery. In Michigan, Blue Cross Blue Shield of Michigan, Blue Care Network, Priority Health and Health Alliance Plan have programs to ensure members have carefully weighed their options.

Nationally, more than 1.2 million spinal surgeries are performed each year, including spinal fusion and decompression, or discectomy, surgery, according to the National Center for Health Statistics. The fastest-growing types the past decade have been lumbar spinal fusion surgeries that range from $60,000 to $110,000 per procedure.

Some studies have shown that the back surgery failure rate, known as failed back syndrome, is as high as 50 percent. But most spine experts say one-third of patients will have successful outcomes, one-third will have no change and one-third will be worse off.

Since 2007, Priority Health has cut down on back surgery costs by requiring patients who have non-emergency surgery to consult with a rehabilitation doctor, or physiatrist, about treatment options before surgery, said John Fox, M.D., Priority’s medical director.

During the first year of the spine program, Priority had an $8 million reduction in costs. Surgery costs fell 24 percent and imaging 18 percent.

Over the past dozen years, health care costs have risen and the population Priority serves has nearly doubled, Fox said. “Our spine surgery rate was 4.1 per thousand in 2006 and today it’s 2.1 per thousand,” he said. “For the commercial population of just over 500,000, that translates into a cost savings of $36 million per year in avoided costs.”

 

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Photo: Jay Greene/Crain’s Detroit Business

SI-BONE, Inc. Announces France’s National Healthcare System Establishes Exclusive Positive Coverage for the Triangular iFuse Implant System® for MIS SI Joint Fusion

SANTA CLARA, Calif.Aug. 27, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the minimally invasive surgical (“MIS”) treatment of the sacroiliac (“SI”) joint with the iFuse Implant System® (“iFuse”) announced that iFuse will be added to the List of Refundable Products and Services in France (Liste des Produits et Prestations Remboursables – LPPR), meaning that the French National Healthcare System will cover the iFuse ProcedureTM.  Reimbursement, which is exclusive to the iFuse ImplantTM, has been established following the favorable opinion of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS), begins September 6, 2018 and is effective for an initial period of five years.

The CNEDIMTS concluded, in its opinion of December 5, 2017*, that the iFuse Procedure’s observed outcomes, including improvements in quality of life and work status, are sufficient to include iFuse on the list of Products and Services provided for in Article L.165-1 of the Social Security Code. The Commission recommends brand name registration for the iFuse Implant System with the following indications: second-line treatment of sacroiliac joint dysfunction caused by sacroiliac joint disruption or degenerative sacroiliitis in patients who fail to respond to conservative treatment. Before treatment with iFuse, a diagnosis of unilateral or bilateral SI joint dysfunction must have been confirmed with positive responses to at least three out of the five SI joint provocative maneuvers (iliac wing spacing test (distraction), iliac wings approximation test (compression), the vertical compression test of each SI joint (thigh thrust), the sacral test (Faber) and the shear test of the two supine SI joints (Gaenslen), and a positive response to palpation of the SI joint. Patients who meet the above criteria may experience relief from diagnostic injections with anesthetics and/or corticosteroid injections in the sacroiliac joint. If the clinical response to an anesthetic injection is significantly positive, the sacroiliac joint may be considered as the source of the pain, and treatment with iFuse is indicated absent any contraindications.

The commission recommends reserving the use of the iFuse Implant device to surgeons who are accustomed to using image-guided surgery and who have received specific training on the iFuse Procedure.

The iFuse Implant System® implant is included in the LPPR list under the code 3147413, the corresponding act is NEDB454 “Arthrodesis of the Sacro-iliac joint by transparietal way, with radiological guidance”.

*https://www.has-sante.fr/portail/upload/docs/application/pdf/2018-01/ifuse_5_decembre_2017_5386_avis.pdf

The iFuse ImplantTM, available in Europe since 2010, is the only SI joint fusion device believed to be supported by multiple prospective clinical studies, including two randomized controlled trials, showing that the device improves pain, patient function and quality of life. The body of peer-reviewed published clinical evidence, unique to the iFuse Implant, has enabled government and private payors to establish positive coverage exclusive to the iFuse triangular implant. There are over 55 peer-reviewed publications supporting the safety, effectiveness, biomechanical and economic benefits of the iFuse Implant. (www.si-bone.com/results).

About SI joint dysfunction

The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating. SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes. SI joint dysfunction can be identified when a patient points to the source of their pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test6, combined with a number of positive provocative maneuvers that stress the SI joint and elicit pain, followed by diagnostic injections to confirm the diagnosis. The SI joint is the largest of the eight major joints in the human body and is believed to be the last to have a proven surgical treatment.

About SI-BONE, Inc.

SI-BONE, Inc. (Santa Clara, California) is a leading medical device company that developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. In the United States, the iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2018 SI-BONE, Inc. All Rights Reserved. 10217.082718

  1. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
  6. Fortin JD, Falco FJ. The Fortin finger test: an indicator of sacroiliac pain. Am J Orthop (Belle Mead NJ). 1997;26(7):477–480.

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

MiMedx Announces Statistically Significant Results In New Multicenter Clinical Study Of Healing Of Diabetic Foot Ulcers Using EpiFix®

MARIETTA, Ga.Aug. 24, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ : MDXG ), a leading developer and marketer of regenerative and therapeutic biologics, today announced that a new study regarding the use of EpiFix® in the treatment of diabetic foot ulcers (DFUs) has been published in the peer-reviewed journal, International Wound Journal.

The paper is entitled “A Confirmatory Study on the Efficacy of Dehydrated Human Amnion/Chorion Membrane dHACM Allograft in the Management of Diabetic Foot Ulcers: A Prospective, Multicenter, Randomized, Controlled Study of 110 Patients from 14 Wound Clinics.” The paper was authored by: William Tettelbach, MD; Shawn Cazzell, DPM; Alexander M. Reyzelman, DPM; Felix Sigal, DPM; Joseph M Caporusso, DPM; and Patrick S. Agnew, DPM. The electronic publication of the article in International Wound Journal can be found at https://onlinelibrary.wiley.com/doi/full/10.1111/iwj.12976.

This multi-center randomized and controlled trial was led by William Tettelbach, MD, principal investigator and former Executive System Medical Director of Wound Care and Hyperbaric Medicine Services for InterMountain Healthcare. Dr. Tettelbach is now Associate Chief Medical Officer for MiMedx, a position that postdated the completion of the study.

Clinical Study Design and Results

The objective of the study was to determine the safety and effectiveness of EpiFix as compared to standard of care (SOC) therapy for the treatment of non-healing DFUs. The primary efficacy endpoint was the incidence of complete wound closure over a 12-week period. Data from 110 patients meeting study inclusion and exclusion criteria were analyzed in the Intent-to-Treat (ITT) cohort. A total of 98 patients completed the study Per Protocol (Per-Protocol cohort).

ITT analysis requires patients to be included even if they did not fully adhere to the protocol. In comparison, in a Per-Protocol analysis, only patients who completed the entire clinical trial according to the protocol are counted towards the final results.

In the current study on an ITT basis, 70% of patients who received weekly EpiFix had complete healing by 12 weeks versus 50% of patients only receiving weekly SOC (EpiFix 70% vs. SOC 50%, p=0.0338).

For patients completing the study per protocol, 81% of those who received weekly EpiFix treatments achieved complete healing by 12 weeks. In comparison, 55% of patients had complete healing in 12 weeks after receiving weekly SOC alone (EpiFix + SOC 81% vs. SOC 55%, p=0.0093).

In the ITT cohort, adjusting for co-variates associated with healing, Cox regression analysis showed patients treated with EpiFix were more than twice as likely to heal completely within 12 weeks as those not receiving EpiFix  (HR: 2.15, 95% confidence interval 1.30-3.57, p=0.003).

Mechanism of Action     

EpiFix® is a tissue matrix allograft composed of dehydrated human amnion/chorion membrane (dHACM). The Company’s published scientific work indicates that MiMedx dHACM retains a diverse array of regulatory proteins including essential growth factors, cytokines and chemokines, which are regulators in inflammation, wound repair and tissue regeneration.

About MiMedx 

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to provide physicians products and tissues to help the body heal itself. The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements. Statements regarding the safety and efficacy of EpiFix are forward-looking statements. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

Caldwell Cassady & Curry Helps Acantha Win $8.2 Million Patent Infringement Verdict Against Medical Device Giant DePuy Synthes

GREEN BAY, Wisc., Aug. 23, 2018 /PRNewswire/ — The Dallas-based intellectual property and business litigation law firm Caldwell Cassady & Curry has won an $8.2 million patent infringement verdict for Acantha LLC against medical device manufacturer DePuy Synthes, a subsidiary of health care giant Johnson & Johnson (NYSE : JNJ ).

A jury of five women and three men issued the unanimous verdict on Aug. 21, 2018, following seven days of trial before the Hon. Chief Judge William C. Griesbach in the U.S. District Court for the Eastern District of Wisconsin in Green Bay. Jurors reached their verdict following five hours of deliberations.

DePuy Synthes was sued in 2015 based on claims that it had infringed an Acantha patent, U.S. Patent No. RE43,008 (‘008 patent), which covers an orthopedic implant assembly used to join bone segments. Acantha’s ‘008 patent was originally issued in 2001 before being reissued in 2011 by the U.S. Patent and Trademark Office.

The Caldwell Cassady & Curry trial team representing Acantha at trial included Brad CaldwellAustin CurryChris StewartJohn Summers and Seth Reich.

Jurors heard evidence that David Talaber, one of the two co-inventors of the ‘008 patent, informed DePuy Synthes’s predecessors about the patent in writing and by phone the year after it was issued.

Mr. Talaber’s co-inventor, Dr. James Lloyd, later traveled to DePuy’s Massachusetts headquarters in 2006 to explain how Acantha’s patent could help with problems DePuy experienced with its implant devices. The DePuy companies never licensed the patent.

Acantha asserted that DePuy Synthes subsequently infringed the ‘008 patent in a series of spine implant devices, including the Zero-P VA System and the Vectra, Vectra-T, and Vectra-One products.

The Green Bay jury found that the DePuy companies willfully infringed Acantha’s patent, awarding $8.2 million in actual damages. The case is Acantha LLC v. DePuy Synthes Sales Inc., et al., No. 1:15-CV-01257.

Caldwell Cassady & Curry represents companies and individuals in high-stakes civil litigation, including patent infringement cases, trade secrets claims, fiduciary duty cases, class actions, and disputes involving company founders. The firm has tried and won some of the nation’s top verdicts against the largest companies in the world. For more information, visit www.caldwellcc.com.

For more information, contact Bruce Vincent at 214-763-6226 or bruce.vincent@musecommunicationsllc.com.

SOURCE Caldwell Cassady & Curry

Related Links

http://www.caldwellcc.com

First Silony VERTICALE Open Procedures Performed in United States

MIAMIAug. 22, 2018 /PRNewswire/ — Silony Medical is pleased to announce that it has performed its first lumbar cases in the US. Silony offers tailor-made sets of sterile pedicle screws ranging from 4.5 to 10.2mm width in 25 to 100mm lengths. One of the initial users, Dr. Mehta at St. Mary Medical Center in Hobart IN, was very satisfied with the quality, intuition and efficiency of the instrument sets and their multi-functionality given Silony’s clinically driven approach. Furthermore, the hospital´s operating room staff provided very positive feedback in regards to simplicity, handling, and quality of Silony´s products. More than 55,000 screws have been implanted in countries like Germany, UK, AustriaItaly and the Netherlands since late 2013. Silony is a fast growing family-owned spine company, developing and producing all its high-quality products in Germany. Silony is currently present in more than 10 countries and is now successfully entering the US market. All Silony products are developed in close cooperation with an international board of surgeons and other hospital experts.

VERTICALE is a posterior double rod fixation system for stabilizing the thoracic and lumbar spine. The system was developed in close cooperation with experienced and qualified spinal surgeons as well as theatre and sterilization staff in surgical environments. As a result, VERTICALE is a well-designed, modular and versatile fixation system.

The VERTICALE system is made up of polyaxial, monoaxial, uniplanar and iliac screws that are available as short head and long head screws (reduction screws). This range of pedicle screws, in either solid or cannulated and fenestrated versions, combined with 5.5-mm titanium or cobalt chromium rods means that the VERTICALE system is suitable for a wide range of indications. Degenerative spinal diseases can be stabilized in a controlled manner and deformities can be comfortably corrected.

Contact Information

E-mail: 

info.usa@silony-medical.com

Phone number: 

305 916 0016

Website: 

http://us.silony-medical.com/

 

Verticale Open (PRNewsfoto/Silony Medical)

Centinel Spine Announces Initial Cases with FLX™ Platform of 3D Printed All-Titanium Interbodies

NEW YORKAug. 23, 2018 /PRNewswire/ — Centinel Spine, LLC announced today that it has completed initial cases with three different implant portfolios within their FLX™ Platform of Integrated Interbody™ and non-integrated interbody fusion devices.  Centinel Spine is the largest privately-held spine company focused on anterior column reconstruction.

FLX devices are 3D-printed, all-titanium implants which feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, as compared to solid titanium implants.  The devices also feature a proprietary FUSE-THRU™ trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.  Centinel Spine received FDA-clearance for multiple cervical and lumbar interbody fusion device families in May of this year.

“FLX offers me another great material choice to add to my fusion armamentarium,” says Dr. Jason Garber, a Neurosurgeon with Las Vegas Neurosurgical Institute, implanting STALIF C FLX™ Cervical Integrated Interbody and STALIF M FLX™ Lumbar Integrated Interbody devices. “With STALIF® implants made from PEEK, titanium-surfaced PEEK, and now 3D-printed titanium, I have the unique opportunity to provide my patients with optimal care options for their individual and specific needs.”

STALIF FLX Integrated Interbody devices offer a unique advantage over other all-titanium implants—as they are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft.

Dr. Stelios Koutsoumbelis, Chief of Division of Orthopedic Surgery at South Nassau Communities Hospital, performing the first ACTILIF C FLX Cervical Interbody implantation comments, “The FLX implant offers an open bone graft window optimizing graft volume and allowing bone growth throughout the trabecular matrix structure.  The open configuration also allows for CT visualization post-operatively to assess fusion.”

“The initial implantations of these FLX products represent a significant milestone in the evolution of our interbody technologies and advanced material platforms.  Our FLX products merge the proven benefits of the STALIF design with a truly novel, all-titanium lattice technology.  This provides surgeons the flexibility to use multiple implant material options through a single set of instruments to address each patient’s unique pathology,” says Centinel Spine Chairman & CEO, John Viscogliosi.

Centinel Spine—the pioneer of the No-Profile®, Integrated Interbody—has a 30-year global clinical history of success behind these devices for the treatment of degenerative disc disease.  The FDA clearance of the FLX platform is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading spine company, addressing spinal disease anteriorly with the widest breadth and depth of technology platforms.

About Centinel Spine, LLC.

Centinel Spine, LLC is a privately-held spinal device company leading the development and commercialization of the No-Profile, Integrated Interbody fusion technologies. The company recently acquired the prodisc® Total Disc Replacement portfolio, an extensive cervical and lumbar disc replacement platform with the longest history of global clinical use.  For more information on Centinel Spine products and technologies, please visit the company’s website at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica, LLC and Surgicraft, LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column reconstruction spine franchise—providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign”, the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi

SVP, Corporate Finance & Strategic Planning, Centinel Spine, LLC

900 Airport Road, Suite 3B

West Chester, PA 19380

Phone: 484-887-8871

Email: v.gandhi@centinelspine.com

Wendy F. DiCicco

Chief Operating and Chief Financial Officer, Centinel Spine, LLC

900 Airport Road, Suite 3B

West Chester, PA 19380

Phone: 484-887-8837

Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine, LLC

(PRNewsfoto/Centinel Spine, LLC)

Related Links

http://www.CentinelSpine.com

Stimwave Names Industry Veterans Paul LaViolette and Jeffrey Goldberg to Board of Directors

August 23, 2018

POMPANO BEACH, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, announced today that Paul LaViolette, managing partner and chief operating officer of SV Health Investors and former COO of Boston Scientific, and Jeff Goldberg, former president of Al Mann’s medical-technology incubator, joined Stimwave’s Board of Directors.

“Paul is an inspirational thought leader who has helped grow companies who were disruptive in health care into multi-billion dollar enterprises, while improving the lives of millions,” said Stimwave Chairman and CEO of Laura Tyler Perryman. “He will be an outstanding addition to our board.”

LaViolette built and ran medical device businesses for 29 years, and he was chief operating officer at Boston Scientific (BSC). During his tenure, the company grew revenue over 20 times. He integrated two dozen acquisitions and led extensive product development, manufacturing and worldwide commercial organizations.

“It’s an honor and a privilege to come aboard with Stimwave as it deploys its innovative technology to market,” said LaViolette. “Medical devices focused on increased access, minimal invasiveness and state of the art technology are the future of health care, and Stimwave is well positioned to expand the neuromodulation market.”

“Jeff Goldberg served a critical role within Al Mann’s enterprises for many years, and Stimwave holds the same principles of creating a technology platform that can benefit patients’ lives, while increasing the market considerably by reimagining how we deliver neuromodulation,” said Perryman. “Familiarity with industry disruptor products such as Stimwave will be invaluable to our future growth plans as we continue to transform our business at an accelerated pace.”

Goldberg has been an executive and advisor in the health care industry for over 25 years. Recently, he served as chair of the board of Angiotech Pharmaceuticals and Physiotherapy Associates and is now serving as chair of the board of 21st Century Oncology, LifeCare Health Partners, Corizon Health, and M*Modal.

“The opportunity to treat pain without implanting a large battery, like what Laura and the Stimwave team are offering patients and their physicians, represents the same type of dramatic innovation that characterized Al Mann’s most successful companies,” Goldberg said. “I am honored to work with as creative and dynamic a leader with Laura and look forward to our journey together.”

Stimwave’s devices are the premier wireless stimulators, using Wireless Pain Relief® technology that allows them to be 95 percent smaller than any other neuromodulation device on the market. These devices treat back and leg pain, as well as treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.

About Stimwave LLC

Stimwave LLC is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Contacts

Glodow Nead Communications
Lori Puccinelli Stern, Rosemary O’Brien and Sarah Rodgers, 415-394-6500
StimwavePR@GlodowNead.com

Osseus Fusion Systems’ new family of 3D printed titanium spine implants receives FDA approval

by  / 22 August 2018

A Texan medical device company has received FDA approval for five new spinal implants 3D printed in titanium.

The family of five FDA 510(k)-cleared lumbar interbody fusion devices is being brought to market by Osseus Fusion Systems under the brand name, Aries. Osseus has been working to develop advanced technology products to enable minimally invasive surgery since it was founded in 2012. In doing so, the company has developed PL3XUS, its proprietary 3D printing technology which uses powder bed fusion to build parts in titanium.

Aries devices boast 80% porosity, increased bone packability and low stiffness, per Osseus, and are manufactured in 30-micron layers before being sintered. A rigorous post-processing phase then optimises the devices ready for clinical use.

The implants are designed to help surgeons ease back pain, and are said to help with faster healing, improved bone growth and enhanced radiovisibility. They represent the first FDA-cleared 3D printed implants Osseus has developed, and double the volume of the company’s portfolio. Osseus says Aries is the first range of many 3D printed products it is working on, and with more to come, the company believes it now has an edge over its competitors.

 

READ THE REST HERE

Photos: Osseus Fusion Systems / TCT Magazine

Promising ACL surgery outcomes for aging athletes

ROSEMONT, Ill.Aug. 21, 2018 /PRNewswire/ — One of the most common knee injuries is an anterior cruciate ligament (ACL) sprain or tear, and doctors are seeing a greater number of older athletes end up in their offices with the injury. An estimated 200,000 ACL-related injuries occur annually in the United States.

Some patients choose to undergo surgical reconstruction of the ACL while others opt for non-surgical intervention. A new review article published in the August 15th issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) discusses surgical and non-surgical treatment options for patients over the age 40 with ACL injuries and proposes shared decision-making about care between patients and doctors.

“The benefits of staying active throughout your life greatly outweigh the risks,” emphasized lead study author and orthopaedic surgeon Matthew Salzler, MD. “ACL tears are an unfortunate but treatable injury that can occur, especially in sports that require sudden twisting and pivoting movements.”

Aging ACLs have a reduced potential to heal and a lower capacity to bear significant strain, as demonstrated in one study highlighted in the review article that compared rats injected with younger and older human ACL-derived cells. Older ACLs may also show greater degeneration.

The review article authors highlight that deciding between surgical and non-surgical treatment options depends on a patient’s activity level and should be a part of a doctor’s initial evaluation when treating patients for an ACL injury. The patient’s history of knee injuries and functional needs should be considered.

According to the article patients of all ages benefit from the rest, ice, compression and elevation (RICE) approach; therefore, this should be the initial management for ACL injuries. This helps reduce pain and swelling, and protects the knee from additional injury. In addition, early physical therapy may help return range of motion and knee stability.

The review article also highlights that the “rule of thirds” has been used for over 25 years to describe different types of patients. They may be classified as:

  • Copers: Able to resume all of their previous activity without any issues for at least one year after the injury.
  • Adapters: Modify or reduce activity after their injury.
  • Non-copers: Require ACL reconstructive surgery because they can’t get through everyday tasks.

The authors explained that though this pattern is not evidence-based, the concepts are relevant when treating patients over 40 as they’re more likely than younger patients to modify their activity over opting for surgical reconstruction.

The article states that the ideal candidates for reconstructive surgery are generally patients who haven’t shown enough improvement with physical therapy alone, want to participate in sports that require sudden pivoting or cutting – like basketball or skiing – and don’t have extensive degenerative changes.

In two systematic reviews of older patients who underwent ACL reconstruction, improvements and positive outcomes were found in knee stability and patient satisfaction. The Swedish National Anterior Cruciate Ligament Register also reported that while older patients had worse knee injury and osteoarthritis scores before surgery than younger patients, their scores after surgery were markedly better, and they showed the greatest improvement one, two, and five years after surgery.

“The outcomes of ACL reconstruction surgeries in patients over 40 are as good as – if not better than – those in younger patients,” says Dr. Salzler.

For patients leaning towards avoiding surgery, the study authors point out that there is conflicting data on the outcomes of nonsurgical treatment in those older than 40. One study of patients with ACL injuries aged 40 to 59 years that did not have surgery had worse outcomes than those that underwent reconstruction. However, in a separate study of Alpine skiers, those treated without surgery fared better than surgical patients.

“As with younger patients, an insufficient or torn ACL is likely to lead to an increased risk of knee instability, meniscal tears, and arthritis,” Dr. Salzler explains. “Whether a patient undergoes surgery or attempts non-operative management of an ACL tear requires a discussion with their orthopaedist.”

The full study is available at: http://bit.ly/2mq18yI

More information about the AAOS and JAAOS 

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Follow the conversation about JAAOS on Twitter

Disclosures 

From Department of Orthopaedics, Tufts Medical Center, Boston, MA (Dr. Salzler), the Department of Orthopedics, University of Colorado at Denver, Anschutz Medical Campus, Aurora, CO (Dr. Chang), and Boston Sports and Shoulder Center, New England Baptist HospitalWaltham, MA (Dr. Richmond). Dr. Salzler or an immediate family member is a board member or committee member of the American Orthopaedic Society for Sports Medicine. Dr. Richmond or an immediate family member serves as a paid consultant to Histogenics, Mitek, and Visgo Therapeutics; has received royalties and financial or material support from Springer and Wolters Kluwer Health–Lippincott Williams & Wilkins; and is a board member or committee member of the Arthroscopy Association of North America and Eastern Orthopaedic Education Foundation. Neither Dr. Chang nor any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this article. J Am Acad Orthop Surg 2018; 0:1-9 DOI: 10.5435/JAAOS-D-16-00730 Copyright 2018 by the American Academy of Orthopaedic Surgeons.

SOURCE American Academy of Orthopaedic Surgeons

Related Links

http://www.aaos.org

EOS imaging Achieves Its 100th Installation in the United States

August 21, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced that the Methodist Dallas Medical Center installed an EOS® system for low-dose, 2D/3D imaging of adult and pediatric patients. The installation marks the 100th system installed in the United States and the 10th system in Texas.

Methodist Dallas Medical Center is part of the Methodist Health System that operates 10 hospitals in Texas and more than two dozen Methodist Family Health Centers and Medical Groups. The Methodist Dallas Medical Center has developed a comprehensive Neurological and Spine program with surgical staff specializing in back pain, tumors, stroke conditions, spinal disorders and injuries as well as other neurological conditions.

Achieving the 100th EOS® installation in the U.S. and 10th in the state of Texas represent great milestones for our Company that reflect the adoption of the EOS technology as a standard of care in all orthopedic points of care, including the large and high growth community hospitals and private practices market,” said Marie Meynadier, CEO. “Addressing the needs of these care providers in the U.S. has been an important part of our commercial strategy in the last year, and we are happy to see that our investments are prompting an acceleration of the EOS® adoption. Our dynamics in the U.S., our largest and fastest growing market, have reached an excellent pace and together with our momentum in all markets provide confidence in our growth.”

About EOS imaging

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteo-articular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Press Relations (US)
Kirsten Thomas
The Ruth Group
Ph: 508-280-6592
kthomas@theruthgroup.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com