Safety and Efficacy of New Class of Orthopedic Implant for Intramedullary Biologic Stabilization of Fractured Long Bones Studied Out to 1 Year

March 23, 2017

LEXINGTON, Mass.–(BUSINESS WIRE)–CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, announced today it has published safety and efficacy data at one year showing that percutaneous intramedullary fixation can provide for stabilization of bone fractures while avoiding the need for open surgery. Results of this study have been published in the Journal of Orthopaedic Research.

“Our study further evaluates the percutaneous application of the IlluminOss System, which is a light-curable photodynamic bone stabilization device developed by IlluminOss Medical as a safe and biocompatible treatment for fracture stabilization and repair in load-bearing bones, such as the long bones of the leg,” said co-investigator Brett G. Zani, Ph.D., Director of Applied Sciences, CBSET.

“Local biocompatibility evaluations comparing the IlluminOss System to standard K-wire implants showed no significant long-term local tissue reactions associated with either implant, and good systemic biocompatibility of the IlluminOss System over the course of a year,” added co-investigator and CBSET scientist Amanda L. McSweeney.

The IlluminOss System is commercially available in international markets under a CE Mark for approved clinical applications through both a direct sales force and distribution networks. It combines the use of proven medical polymers and traditional balloon catheter technology to provide a completely new technology for patient-specific, percutaneous orthopedic implants. The implant begins as a liquid monomer that is completely contained within a Dacron or PET balloon. Once inside a patient’s bone, it conforms to the geometry of that patient’s intramedullary canal, whereas traditional rigid intramedullary rods have only small discrete contact points. Now, international surgeons have the option to use the IlluminOss product alone or in conjunction with traditional hardware and screws for multiple types of fractures.

“CBSET’s high-quality preclinical evaluation continues to substantiate the application of our bone stabilization system and its potential to be a truly disruptive alternative to traditional fracture repair,” said Robert Rabiner, Chief Technical Officer & Founder of IlluminOss Medical.

“CBSET strives to help innovative companies such as IlluminOss to develop new and disruptive technologies that foster paradigm-shifting improvements in patient care. In this case, for patients requiring fracture-fixation in an orthopedic trauma care unit, access to a new solution that is metal-free and can be performed in a minimally invasive manner, and not open surgery, is exciting, and our organization is proud to have contributed,” said Peter Markham, President, CEO and a co-founder of CBSET.

To learn more about these results and the services provided by CBSET, please contact: Michael Naimark, Director, Business Development: +1-970-988-5273, mnaimark@cbset.org.

* The IluminOss™ System is approved for sale in Europe and for investigational use in the U.S.

About CBSET
CBSET Inc. — 500 Shire Way, Lexington, Mass. — is the preclinical research leader in therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products. Learn more about CBSET’s expert biomedical research services.

Contacts

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

Extremity Reconstruction Market – Detailed Study Analysis and Forecast by 2025

Albany, NY — (SBWIRE) — 03/24/2017 — Global Extremity Reconstruction Market: Overview

The increasing incidence of injuries, abnormalities, and congenital defects in the upper or lower extremity of human body has fuelled the demand for reconstructive surgical procedures. Implant devices for the shoulder, wrist, ankle joints, digits, elbow, and foot are part of the extremity reconstruction market.

The primary driver of the global extremity reconstruction market is the large pool of geriatric population. According to the Centers of Disease Control and Prevention, with a rise in the geriatric population in the U.S., by the year 2040, the number of patients affected by arthritis is expected to increase to 78 million. Since aged people are more prone to injuries, growth in geriatric population is expected to fuel the demand for reconstructive surgical procedures.

Obtain Report Details @ https://www.tmrresearch.com/extremity-reconstruction-market

Global Extremity Reconstruction Market: Key Trends

The rising incidence of joint disorders such as rheumatoid and osteoarthritis arthritis, coupled with the globally increasing incidence of diabetes and obesity, and rising geriatric population are driving the global extremity reconstruction market. Moreover, growing awareness among patients about the advantages of small joint reconstruction implants and enhanced technology such as development of reverse shoulder implants, stemless shoulder implants, and ankle reconstruction implants, which aid in recovering ankle mobility are projected to boost the market. The zest to get back to the active lifestyle, post-injury or trauma will supplement the demand for extremity reconstruction surgeries.

 

READ THE REST HERE

Centrexion Therapeutics to Present Data on CNTX-4975 from the Treatment of Knee Osteoarthritis Pain at IX SIMPAR-ISURA

March 23, 2017

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics, a company focused on advancing the treatment of chronic pain with one of the largest exclusively pain-focused pipelines of non-opioid therapies in active development, today announced it will present 12-week data from TRIUMPH, a Phase 2b clinical trial of CNTX-4975 for the treatment of moderate to severe knee pain associated with osteoarthritis, at the IX SIMPAR-ISURA (Study in Multidisciplinary Pain Research – International Symposium of Ultrasound for Regional Anesthesia and Pain Medicine) meeting taking place March 29 – April 1, 2017 in Florence, Italy.

Full abstracts are available online at http://www.simpar-pain.com/. Details of the poster presentation are listed below. Additional data from the TRIUMPH study will be presented at medical meetings later this year.

Abstract Title (#41): CNTX-4975 Administration in Subjects With Knee Pain Associated With Osteoarthritis: 12-Week Results of a Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study
Poster Viewing: Noon CET, March 30 – 4:00 p.m. CET, April 1, 2017
Poster Discussion: 4:00 – 4:30 p.m. CET, March 31, 2017
Location: Florence Congress Palace

About CNTX-4975

CNTX-4975 is based on Centrexion’s proprietary STRATI® technology (Synthetic TRans cApsaicin ulTra-pure Injection), a highly potent, ultrapure, synthetic form of trans-capsaicin (a medicine traditionally derived from the chili plant). CNTX-4975 is designed to be injected directly into the site of pain to provide rapid onset, large reduction and long duration of relief from moderate to severe pain without affecting touch sensibility or position sense.

CNTX-4975 works by selectively targeting the capsaicin receptor (TRPV1) to rapidly inactivate only the local pain fibers transmitting signals to the brain. With a short half-life, STRATI® is cleared from the body within 24 hours. This approach provides pain relief that can last for months until the ends of the local pain fibers regenerate, while maintaining normal sensation, such as touch, pressure and position, and without the risks of toxicities of NSAIDs and injected corticosteroids or the side effects, including abuse and addiction, associated with opioid treatments.

About Centrexion Therapeutics

Centrexion Therapeutics, Corp. is focused on advancing the treatment of chronic moderate to severe pain with one of the largest exclusively pain-focused pipelines of non-opioid, non-addictive therapies in active development. Centrexion Therapeutics recognizes the needs of over a quarter of a billion people living with chronic pain worldwide, and aims to develop new, safer and more effective therapies that overcome the limitations and challenges associated with current pain treatments. Founded by world-renowned leaders in drug development and well-funded by key investors, Centrexion Therapeutics is building a pain treatment powerhouse to address the substantial and growing global chronic pain epidemic. Centrexion Therapeutics has recently relocated from Baltimore, Md. to Boston, Mass.

For more information about Centrexion, visit http://www.centrexion.com.

Contacts

Pure Communications, Inc.
Julie Normart, +1-415-946-1087
jnormart@purecommunications.com

It’s not magic; it’s science

Steve Collins, Contributor – CFO/COO Oska, Inc.

If you suffer from chronic pain, it’s likely you’ve chased rainbows, been let down by false marketing claims or – at worst – lost hope that anything will emerge to help manage your pain effectively. Additionally, you’ve probably spent considerable amounts purchasing items that just don’t perform as stated. Sadly, for those suffering, things are getting worse. Recent Centers for Disease Control policies have emphasized prescribing less opiate pain-killers and the Drug Enforcement Administration has announced it intends listing kratom, an herbal pain-relief supplement, as a “schedule I” substance. This means that whether you are currently using prescribed narcotic pain-killers, or an herbal substitute, you will have no choice but to identify and use other pain-relief options.

The human body is wondrous, and its capacity to heal itself is amazing. Think of a scraped knee, bruised heel or sprained ankle. The body’s own healing processes kick in automatically in response to injuries. Chronic pain, however, is more challenging to manage. Most times, because chronic pain exists in localized unstable body areas, the natural healing processes need a kick-start. TENs devices, creams, pharmaceuticals and even physical therapy tend to be effective, but only for short periods as they “interrupt” pain rather than actually addressing the source. Ask any doctor or physical therapist the key to recovery, and most will say “exercise”. But if you already experience pain, the mere thought of exercise may fill you with anxiety.

What if it was possible to exercise an injury without leaving your chair, touching your toes or wrestling with a physiotherapist? What if there was an alternative option to swallowing dangerous narcotic or analgesic pain-killers?

Have you ever heard of pulsed electromagnetic field therapy (PEMF)?

PEMF, as a science, has been used for over 60 years with no known adverse effects. NASA uses it as an effective means of countering bone-density loss and muscle atrophy in astronauts exposed to weightless environments for prolonged periods. In fact, it is so effective that the FDA has cleared PEMF to close bone fractures, for mitigating migraines and for orthodontic work. If you think an electromagnetic field sounds “wacky”, consider that Earth generates one and so does your body!

PEMF emits very low-frequency waves that are created many times each second. These waves push and pull on human cells causing them to squeeze and stretch. As a result, cells can breathe more easily, allowing important healing signals to be carried into the cell. These signals then activate its natural recovery response and cause it to exhale even more healing signals into the surrounding area, promoting intensive healing. An injured area is typically not functioning normally, and if the healing process is compromised, pain can become chronic. When PEMF is introduced into the injured area, it acts at the cellular level to kick-start the body’s natural healing process.

A PEMF device produces similar effects as physical exercise, but you won’t feel anything. Typically, PEMF devices deliver three things: reduced pain levels; reduced inflammation; and improved range of motion. Whereas a TENs unit merely interrupts a pain signal, PEMF actually works at the cellular level, allowing for natural healing. Significantly, a PEMF device does not cause the usual discomfort experienced via a TENs unit because it is noninvasive (lacking physical attachment requirements) and is portable (you can use it at home, at work, in the car).

PEMF is a lesser-known therapy amongst consumers, but it provides scientifically superior results. It seems miracles can happen! CDC: we are looking at you!

 

READ MORE ABOUT OSKA HERE

 

 

Integra LifeSciences Launches Press-Fit Reverse Shoulder for Fracture for the Titan™ Modular Shoulder System

PLAINSBORO, N.J., March 15, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation  (Nasdaq:IART), a leading global medical technology company, announced the launch of the Titan™ Press-Fit Reverse Shoulder for Fracture.

The use of the reverse shoulder to treat humeral fractures has increased in recent years. However, heat from cement used to secure the prosthesis can hinder healing of the bone, which negatively impacts patient outcomes.1 The Titan reverse is one of the few prostheses that does not require cement, due to its unique two-piece stem that achieves a direct implant-to-bone press-fit fixation below the fracture line in the humeral canal.

Stems that fixate in the humeral canal have a strong clinical heritage, with published literature showing comparable or better functional results in fracture scenarios compared to published studies of other stem designs.2

Matt Ramsey, MD, of the Rothman Institute said, “This product has revolutionized my treatment of proximal humeral fractures. The Titan Press-Fit Reverse allows me to reliably obtain a solid fit in the canal without having to wait for the cement to dry, and the ability to adjust height and version independent of the stem means no fiddling with a jig or making sacrifices on the fit.”

The Titan Press-Fit Reverse for Fracture was developed in conjunction with Matthew Ramsey, MD; William Geissler, MD; Sanford Kunkel, MD; Jean-Marc Glasson, MD; Phillip Duke, MBBS, FRACS, FA(ORTH)A; and Mark Ross, MBBS, FRACS, FA(ORTH)A.

“The Titan Press-Fit Reverse for Fracture is a cornerstone of our shoulder portfolio.  At Integra, we’re committed to creating products that enhance patient care and enrich the surgeon experience.  Our shoulder franchise is poised to redefine expectations in shoulder arthroplasty with this and other products we have in the pipeline,said Bob Davis, president of Integra’s Orthopedics & Tissue Technologies division.

About Integra
Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care.  Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

For additional information on the release of the Titan™ Modular Shoulder System Press-Fit Reverse for Fracture, please contact PressFit.Fx@integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading “Risk Factors” included in Item IA of Integra’s Annual Report on Form 10-K for the year ended December 31, 2015 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

1 Formaini, NT, Everding, NG, Levy, JC, Rosas, S. Tuberosity healing after reverse shoulder arthroplasty for acute proximal humerus fractures: the “black and tan” technique. J Shoulder Elbow Surg 2015 Nov;24(11):e299-306. doi: 10.1016/j.jse.2015.04.014. Epub 2015 Jul 2.

2 Ross, M, Hope, B, Stokes, A, Peters, SE, McLeod, I, Duke, PFR. Reverse Shoulder Arthroplasty for the treatment of three-part and four-part proximal humeral fractures in the elderly. J Shoulder Elbow Surg 2015 Feb;24(2):215-22. doi: 10.1016/j.jse.2014.05.022. Epub 2014 Aug 29.

CONTACT: Integra LifeSciences Holdings Company

Investors
Angela Steinway                                              
609-936-2268                                                                    
angela.steinway@integralife.com

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

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

First Ray Receives FDA 510(k) Clearance for Expanded Stealth Staple™ Product Line

LOGAN, Utah, March 15, 2017 /PRNewswire/ — First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for new additions to the Stealth Staple™ System product family.

Previously, the company received clearance for its “Standard” size implants in different lengths, manufactured from titanium alloy. The new FDA clearance includes: “Standard” size implants manufactured from PEEK, “Small” size implants manufactured from titanium alloy or PEEK, and “Mini” size implants manufactured from titanium alloy. Standard size implants are well suited for hindfoot fusions and first tarsometatarsal joint fusions. Small size implants are well suited for midfoot fusions, first metatarsophalangeal fusions and carpal fusions. Mini size implants are well suited for carpometacarpal joint fusions, lesser metatarsophalangeal fusions, and fixation of Akin osteotomies. Surgeons now have the choice for radiopaque and, for the Standard and Small sizes, radiolucent implants.

The Stealth Staple™ System, an intraosseous small bone fixation system, represents a significant advancement for the treatment of arthrodesis, osteotomies and bone fractures. Current standard-of-care devices used to treat these indications are primarily bone plates and bone screws, or bone staples. Due to the prominence above the bone surface associated with these standard-of-care devices, there are notable clinical rates of device related pain, soft tissue irritation, and second surgeries for hardware removal. Since the Stealth Staple™ is completely contained within the bone upon implantation, clinical complications related to prominent hardware may be substantially reduced.

Another significant advancement provided by the Stealth Staple™ is the creation of controlled and evenly distributed compression across the opposing bone surfaces of an osteotomy or fracture. Finite element analysis and biomechanical testing have demonstrated superior strength, superior bone compression and superior resistance to gap formation compared to bone plate and screw systems (data on file).

First Ray is a development stage medical device company incubated and operated by Surgical Frontiers.  Inquiries regarding distribution and commercialization partnerships are welcome.

About Surgical Frontiers

Surgical Frontiers funds, launches and operates start-up companies to develop advanced surgical technologies that are ready for clinical use. Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Contacts:

Mr. Lane Hale
Executive Vice President
150433@email4pr.com
www.surgicalfrontiers.com
800-230-3710

SOURCE First Ray

The Arthrosurface OVO™ – A Primary Stemless Total Shoulder System

FRANKLIN, Mass., March 14, 2017 /PRNewswire/ — Arthrosurface, Inc. announced today they will be highlighting the OVO™ Primary Stemless Shoulder system along with recent data published supporting their proprietary inlay glenoid shoulder product at the 2017 AAOS conference in San Diego, CA March 15-18 at Booth #2145. The OVO Primary Stemless Shoulder system is intended for primary total shoulder arthroplasty. The unique design consists of a Cobalt Chromium stemless, non-spherical humeral head and a polyethylene inlay glenoid (UHMWPE).

Stemless implants were originally used for young patient with osteoarthritis and minimal bone deformity. The uses have expanded to all age groups with a wide range of pathologies with excellent results. It can be used in all patients in lieu of a standard total shoulder arthroplasty with the advantages of being bone preserving, anatomical, and in appropriately selected patients, able to do as a short stay or same day procedure.

“The OVO Primary Stemless Shoulder system is an excellent choice for the patient who suffers from osteoarthritis of the glenohumeral joint and who desires to maintain an active lifestyle post-surgical intervention,” said Joe Darling, Executive Chairman of Arthrosurface. “In a traditional stemmed implant design, there are lifelong restrictions placed on the patient post-surgery; limits on the amount of weight that can be lifted and certain activities such as yoga are no longer permitted. This is due to the amount of healthy bone that must be removed to allow a long titanium stem to be placed deep inside the humeral canal.   In a stemless implant the amount of bone removal is far less than a stemmed system, related complications are avoided, and minimal lifestyle restrictions are placed on the patient following postoperative recovery and rehabilitation.”

The Arthrosurface OVO™ Primary Stemless Shoulder system is the only system on the market today that offers a non-spherical humeral head which matches the native anatomy more closely than circular head designs offered by the other stemmed and stemless arthroplasty systems. Independent studies have shown that a non-spherical head optimizes the natural movement of the shoulder.

In addition, Arthrosurface is the only system which offers an inlay glenoid.  Glenoid loosening is a significant concern post-surgery and has been attributed to the interaction of the humeral head implant against the outer edges of an onlay glenoid implants, creating a “rocking horse” effect. Recent published data reported no loosening of the Arthrosurface inlay glenoid after 4,000 cycles, whereas all onlay designs tested were clinically loose after approximately 1100 cycles.

The inherent advantages of the OVO Primary Stemless Shoulder system resonate with clinicians which is reflected in double-digit growth rates annually since the market introduction in 2009. The inlay glenoid is expected to be commercially available in Europe later this year.

About Arthrosurface

Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. The product offerings include devices, instruments and biologics designed to preserve and restore the joints so patients can maintain an active lifestyle. The Company offers a variety of unique systems that provide less invasive technologies for surgeons that can be used to treat a wide range of joint conditions. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 13 years. For more information, please go to our website at www.Arthrosurface.com.

SOURCE Arthrosurface, Inc.

Related Links

http://www.arthrosurface.com

Kappa Delta awards honor innovative orthopaedic research

SAN DIEGO, March 16, 2017 /PRNewswire-USNewswire/ — The Kappa Delta Sorority and the Orthopaedic Research and Education Foundation (OREF) today presented four awards to scientists conducting outstanding musculoskeletal disease or injury research with the goal of advancing patient treatment and care. Honored at the 2017 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS), these award winners have made invaluable discoveries in:

  • Using lower extremity biomechanics in patients with ankle osteoarthritis and ankle arthroplasty to direct clinical care;
  • Advancing precision medicine for clubfoot treatment through basic research;
  • Kinematics of the normal and injured wrist: the importance of the midcarpal joint; and
  • The impact of arthroplasty implant registries over the past five decades.

Using lower extremity biomechanics in patients with ankle osteoarthritis and ankle arthroplasty to direct clinical care
The 2017 Kappa Delta Young Investigator Award was presented to Robin Queen, PhD, FACSM, associate professor of biomedical engineering and mechanics at Virginia Tech in Blacksburg, Va., and associate professor of orthopaedic surgery at Virginia Tech Carilion School of Medicine for her research on the impact of ankle osteoarthritis and total ankle replacement on gait mechanics and balance.

Each year, there are approximately 50,000 new cases of ankle osteoarthritis, a debilitating disease that leads to profound skeletal and functional changes, including deformity, severe and recurrent pain, cartilage breakdown and gait dysfunction. Because of the new generation of implants, this was a critical time to examine the impact of ankle osteoarthritis and total ankle arthroplasty on total body mechanics and function. Dr. Queen examined the impact of ankle osteoarthritis and ankle replacement on balance, ankle range of motion, patient outcomes, and movement symmetry to improve long-term health and function.

“It was important for us to understand this patient population in a way that we never have, and to improve their quality of life post surgery, while decreasing the need for additional surgeries,” said Dr. Queen. “We are working to change the way surgeons look at patient recovery. We want them to examine movement and physical performance, not just patient reported outcomes. We need to begin to address the impact that ankle disease and surgery has on the entire body through a more holistic approach as we advance postoperative care in order to improve long-term health and mobility.”

Dr. Queen hopes this research will emphasize the importance of assessing measures like physical performance and not just patient recorded outcomes to assess recovery and to determine what additional postoperative intervention programs are necessary for individual patients.

Advancing personalized medicine for clubfoot through translational research
The 2017 Kappa Delta Ann Doner Vaughn Award was presented to Matthew Dobbs, MD, for his research on advancing personalized medicine for clubfoot. Dr. Dobbs is the Dr. Asa C. and Mrs. Dorothy W. Jones professor of orthopaedic surgery at Washington University in St. Louis. The research was co-authored by Christina Gurnett, MD, PhD, professor Department of Neurology and Division of Pediatric Neurology at Washington University School of Medicine.

Clubfoot is one of the most common pediatric orthopaedic disorders with an estimated one per 1,000 live births. If left untreated, it can result in foot and leg deformities, pain that limits mobility and social stigma. While the Ponseti method has revolutionized clubfoot treatment, it’s not effective for all patients.

Twenty-five percent of patients with clubfoot have a family history of clubfoot. Dr. Dobbs and his wife, Dr. Gurnett co-founded the Musculoskeletal Genetics Laboratory at Washington University where they leveraged scientific advances including human gene sequencing, molecular genetic engineering of mouse models and magnetic resonance imaging (MRI), as well as new treatment technologies to understand and target specific abnormalities.

Their work helped discover mutations in the PITX1, TBX4 and HOXC genes that cause familial clubfoot and vertical talus. And since no one had used MRI to examine the legs of clubfoot patients, they began to look for hypomorphic muscle, bone and vasculature differences in patients.

“Not all cases of clubfoot are the same, so it doesn’t make sense to treat everyone the same,” said Dr. Dobbs. “To improve the lives of all children with clubfoot, we believe it’s critical not only to understand the genetic and morphological abnormalities contributing to foot development, but also to use this information to devise personalized treatment paradigms.”

They started a large, multi-center, randomized clinical trial, to help predict response to treatment and find ways to alter treatment to make it even more effective. Their research has led to the creation of an algorithm to develop to a new classification system; improved brace design to improve patient compliance with the development of the Dobbs foot abduction brace; optimized treatment methods for neglected and syndromic clubfoot; and a new non-operative treatment for congenital vertical talus called the Dobbs method.

“Receiving this award is a true honor. It is our hope that we can continue to develop personalized therapies that minimize the extent of surgery by addressing specific muscular, skeletal, vascular or neuronal abnormalities,” said Dr. Dobbs.

Kinematics of the normal and injured wrist: the importance of the midcarpal joint
Scott W. Wolfe MD, chief emeritus of hand surgery and attending orthopaedic surgeon at the Hospital for Special Surgery in New York City, received the 2017 Kappa Delta Elizabeth Winston Lanier Award for his research titled “Kinematics of the normal and injured wrist: the importance of the midcarpal joint.” The research was co-authored by Joseph J. (Trey) Crisco, III, PhD, Henry F. Lippitt professor of orthopaedics and professor of Engineering (Research) at Brown University.

The eight carpal bones that comprise the wrist joint represent the most complex articular system in the human body–each capable of moving in different degrees or directions dependent on the position, motion and force generation of the hand in space. Any instability of the wrist caused by injury can generate disabling symptoms that prevent normal daily or occupational activities and lead to debilitating, degenerative arthritis in a very short time.

“Our work can be described in three stages, roughly corresponding to the three decades of our collaborative efforts, namely, 1990s: development of non-invasive technology to measure normal carpal bone kinematics during wrist motion; 2000s: application of that technology to understand “functional” kinematics of the normal and injured wrist; and 2010s: conceptualization and development of improved methods for treatment of degenerative arthritis based on our understanding of functional kinematics,” said Dr. Wolfe.

Dr. Wolfe has long recognized the dramatic evolution of computed tomography (CT) and its application to 3D visualization of small bones and joint fractures about the upper limb. Within five years of starting their research, they were able to generate movies of individual wrist bones moving–something that had never been done before–by using the latest CT equipment and advanced technology developed by Dr. Crisco.

In addition to being the first to map the wrist’s movement in the dart thrower’s motion, they were then able to create devices to treat wrist instability including the novel midcarpal total wrist arthroplasty system, which is currently pending FDA approval. Their midcarpal kinematic hemi-arthroplasty has already received CE approval and is currently used in the U.K.

“This award means an enormous amount to us,” said Dr. Wolfe. “It validates what we’ve done for three decades, cements the importance of our research to orthopaedic and clinical care of patients, and it energizes us to double down and take this to the next step.”

Drs. Wolfe and Crisco have already applied for grants to continue their research initiatives.

Arthroplasty implant registries over the past five decades: development, current and future impact
The 2017 OREF Clinical Research Award was presented to Henrik Malchau, MD, PhD-professor of orthopaedics at Harvard Medical School and vice chief orthopaedics and co-director of the Harris Orthopaedic Laboratory Massachusetts General Hospital in Boston-for his research studying the impact of arthroplasty implant registries throughout the world. The research was co-authored by Daniel Berry, MD; Charles Bragdon, PhD; Göran Garellick, MD, PhD;  William H. Harris, MD, ScD; Peter Herberts, MD, PhD; Johan Kärrholm, MD, PhD; David Lewallen, MD; Lars Lidgren, MD, PhD; and Otto Robertson, MD, PhD.

The development of arthroplasty registries in Sweden and the United States has promoted the concept of evidence-based medicine over the past 50 years. The Mayo Clinic Total Joint Registry and the Harris Joint Registry (Massachusetts General Hospital) have greatly contributed to the advancement of arthroplasty surgery, and have served as an important role of identifying poorly performing implants and techniques in the U.S.

The Swedish Knee Arthroplasty Registry and the Swedish Hip Arthroplasty Registry have established the infrastructure, analysis and reporting mechanisms and leadership that have enabled other countries to develop registries around the world.

“I have spent my entire career developing and promoting the use of registries to collect regional, national and global data,” said Dr. Malchau. “As a result, we have been able to identify medical devices and practices that have high rates of failure, while promoting best practices for arthroplasty patients. These registries have supplied the scientific bases for decision making in literally all aspects of arthroplasty patient care.”

As a result of this research, there are now international efforts underway to promote and increase collaboration among various national registries, including the American Joint Replacement Registry to pool data, establish standards and guidelines, and to develop a system of early detection and warning regarding practices and implants that exhibit inferior performance.

About the Kappa Delta Awards
In 1947, at its golden anniversary, the Kappa Delta Sorority established the Kappa Delta Research Fellowship in Orthopaedics, the first award ever created to honor achievements in the field of orthopaedic research. The first annual award, a single stipend of $1,000, was made available to the Academy in 1949 and presented at the AAOS meeting in 1950. The Kappa Delta Awards have been presented by the Academy to persons who have performed research in orthopaedic surgery that is of high significance and impact.

The sorority has since added two more awards and increased the award amounts to $20,000 each. Two awards are named for the sorority national past presidents who were instrumental in the creation of the awards: Elizabeth Winston Lanier and Ann Doner Vaughn. The third is known as the Young Investigator Award.

The fourth award, also providing $20,000, is the OREF Clinical Research Award. Established in 1995, the award recognizes outstanding clinical research related directly to musculoskeletal disease or injury. All submitted manuscripts are reviewed, graded, and selected by the American Academy of Orthopaedic Surgeons’ Research Development Committee. For more information about the manuscript submission process, please visit aaos.org/kappadelta.

Previous Kappa Delta and OREF Clinical Research Award winners

The American Academy of Orthopaedic Surgeons
With more than 39,000 members, the American Academy of Orthopaedic Surgeons (AAOS) is the world’s largest medical association of musculoskeletal specialists. The AAOS provides education programs for orthopaedic surgeons and allied health professionals, champions and advances the highest quality musculoskeletal care for patients, and is the authoritative source of information on bone and joint conditions, treatments and related issues.

Visit AAOS at:
Newsroom.aaos.org for bone and joint health news, stats, facts, images and interview requests.
ANationinMotion.org for inspirational patient stories, and orthopaedic surgeon tips on maintaining bone and joint health, avoiding injuries, treating musculoskeletal conditions and navigating recovery.
Orthoinfo.org for patient information on hundreds of orthopaedic diseases and conditions.
Facebook.com/AAOS1

CONTACT: Kayee Ip, 312-543-3211, 847-384-4035, ip@aaos.org; Lauren P. Riley, 708-227-1773, 847-384-4031, pearson@aaos.org

This information is being sent to you by:
American Academy of Orthopaedic Surgeons
9400 W. Higgins Road, Rosemont, IL , 60018,
http://www.aaos.org

Zimmer Biomet Showcases New Product Innovation, Novel Digital Health Offering and Robotic Technology at AAOS 2017

WARSAW, Ind., March 14, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced plans to highlight its latest commercial offerings and preview its next generation of technological innovations at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting this week in San Diego, CA.  The Company’s state-of-the-art booth (#4333) will feature an immersive and interactive tour of its newly launched digital technology and clinical services offering, Zimmer Biomet Signature Solutions, alongside more than 50 new products from its vast and diversified portfolio.

“We’re proud and excited to showcase our most innovative new commercial offerings to the largest gathering of orthopaedic professionals,” said David Dvorak, President and CEO of Zimmer Biomet. “New this year is a virtual booth experience designed to bring Zimmer Biomet Signature Solutions to life through a guided tour, a sneak preview of our emerging robotics platform and other technologies in our deep pipeline.”

Following is a snapshot of the key highlights being featured at the Zimmer Biomet booth (#4333) at AAOS 2017:

  • Zimmer Biomet Signature Solutions
    • Guided tours through the virtual experience every 15 minutes. Members of the press can reserve a spot by contacting Monica Kendrick at monica.kendrick@zimmerbiomet.com.
  • Robotic Technology
    • Catch a glimpse of the future of personalization and intelligent instrument technology through innovative robotics.i
  • Knees
    • Vanguard® Individualized Design (ID), advances soft tissue preservation and balancing through independent medial and lateral articular surface constraint and thickness options.
    • OSSTM Orthopedic Salvage System, a comprehensive modular platform providing surgeons with intraoperative flexibility often required during limb salvage procedures.
    • Persona® Medial Congruent® Bearing, designed to recreate more natural feeling motion of the human knee by maximizing knee joint stability while allowing mobility.
  • Hips
    • Hip Preservation portfolio of options designed to treat conditions leading up to osteoarthritis and potentially preventing the need for total hip replacement.
    • Trabecular MetalTM acetabular cups, which National Joint Registry analysis has recently shown are 21 percent less likely to be re-revised due to infection (statistically significant, p-value=0.036).ii
    • The latest in dual mobility, Microplasty® and revision implant options designed to address the distinct needs of individual patients while simplifying surgical workflow.
  • Personalized Solutions
    • A comprehensive technology-based portfolio of guides, tools and software to support surgical planning, intraoperative guidance and optimal component placement.
  • Bone Cement
    • StageOneTM and StageOne Select Spacer Molds, designed to mold a temporary knee, hip and shoulder spacer for patients undergoing a two stage revision due to an infected total joint.
  • Diagnostics
    • Synovasure® Laboratory Panel for the detection of Periprosthetic Joint Infection (PJI), now includes Microbial ID. These diagnostic tests provide a fast and easy method to diagnose PJI based on the flagship test, which determines the concentration of Alpha Defensin in synovial fluid. Microbial ID detects the presence of microbes in the synovial fluid in a matter of hours.
  • Extremities
    • Vault Reconstruction System (VRS), the first commercially available patient-matched glenoid implant, cleared to specifically treat patients with severe glenoid bone loss and a deficient rotator cuff.
    • L2LTM Radial Head System, a simple, smooth design solution for replacing the proximal radial head in patients with fractures.
  • Foot and Ankle
    • Deformity correcting products available through our partnership with Nextremity Solutions, Inc., including the Nextra®Hammertoe Correction System, the MSP™ Metatarsal Shortening System and the Re+Line® Bunion Correction System.
    • Subchondroplasty® Procedure for foot and ankle surgery, a minimally invasive outpatient intervention that addresses the defects associated with subchondral bone marrow lesions.
  • Trauma
    • A.L.P.S.® Proximal Humerus Plating System, designed to minimize the risk of complications commonly associated with proximal humerus fractures, such as varus collapse, articular screw penetration and subacromial impingement.
    • N-Force Fixation System® with N-Force Blue, an augmented fixation system, integrating fenestrated screws and a Bone Substitute Material into a single construct to provide improved metaphyseal void fill and increase structural support of the implant.
    • RibFix Blu® Thoracic Fixation System, designed and used for the stabilization and rigid fixation of fractures in the chest wall, including sternal reconstructive surgical procedures, trauma or planned osteotomies.
  • Sports Medicine
    • Quattro® Link, a knotless anchor that brings control and efficiency to soft tissue repair.
    • BioWickTM SureLock®, a rotator cuff implant that is an interpositional bioresorbable scaffold wick.
    • SpeedSnareTM Surgical Suture Passer, which allows the ability to pass a suture through single or multiple ports.
    • Gel-One® Cross-Linked Hyaluronate, the first low-volume viscosupplement available in a single-injection formula, for the treatment of pain in osteoarthritis of the knee that does not respond adequately to other conservative treatments.
  • Biologics
    • nSTRIDE® Autologous Protein Solution (ex-US use only), a single-shot autologous anti-inflammatory for treatment of knee osteoarthritis.
    • AmnioFloTM, allograft derived from human amniotic fluid, for joint cushioning and lubrication.
  • Surgical
    • The IntelliCart™ System Duo Fluid Carts, the foundation for infectious waste technology with market-leading 34-liter capacity, extra quiet vacuum pump, clog-free suction manifolds and portable smoke evacuation.
    • Bactisure™ Wound Lavage, clear, low-odor, aqueous solution designed to remove structurally resistant forms of bacteria, including biofilms, on all wound types.
    • The VasoPress® System, reduces the risk of blood clots associated with deep vein thrombosis by propelling the venous blood out of the deep veins while patients are undergoing surgical procedures or immobile for an extended period of time.
  • Spine
    • Mobi-C® Cervical Disc, the first cervical disc replacement device approved for both one and two-level procedures.
    • Vitality® Spinal Fixation System, an adaptable system designed for spinal fixation in complex thoracolumbar procedures.

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.

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 and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the 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.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, 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.

i Concept device – not for sale in the US

ii 1. According to NJR data from 2003 to 2015 where 9,573 Trabecular Metal and 30,452 non-Trabecular Metal cups were used in revision THA and based on hazard ratios adjusted by patient gender, age group, and indications (OA/non-OA).

2. NJR data shows a higher percentage of TM cups were used with antibiotic bone cement compared to all other non-TM cementless cups.

SOURCE Zimmer Biomet Holdings, Inc.

Global Extremities Market with Focus on Shoulder Implants: Industry Analysis & Outlook 2017-2021 – Research and Markets

March 15, 2017

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Global Extremities Market with Focus on Shoulder Implants: Industry Analysis & Outlook (2017-2021)” report to their offering.

The global extremity market is expected to grow in the future due to the increasing ageing population and obese population, rise in health expenditure and rising diabetic prevalence. Key trends of this market include adoption of minimally invasive surgeries & pre-operative/intra-operative planning software, rising demand of reverse shoulder implants and low reimbursement pressure. However, there are some factors which can hinder the market growth including post-surgery complications and shortage of trained surgeons.

The U.S. was a major contributor in the global extremity market, supported by a rise in sports injuries among young people and increasing cases of osteoarthritis and osteoporosis. The U.S. is likely to experience upcoming growth of the extremity market with technological innovations and rising procedural volume growth in the shoulder extremity segment. Also, the shoulder extremity segment was the largest contributor of the extremity market in the U.S. and is likely to bring growth in the future with increasing numbers of reverse shoulder and stemless shoulder procedures.

The report profiles the key players of the market, including Zimmer Biomet, Johnson & Johnson, Exactech Inc. & Wright Medical Group N.V.

Market Dynamics

Growth Drivers

  • Increase in Ageing Populace
  • Rise in Healthcare Expenditure
  • Increase in Obese Population
  • Increase in Diabetic Prevalence
  • Active Lifestyle in Young Demographic
  • Increasing Awareness of Extremity Treatment

Key Trends

  • Adoption of Minimally Invasive Surgeries
  • Pre-Operative/Intra-Operative Planning Software in Shoulder Cases
  • Low Reimbursement Pressure
  • Mergers and Acquisitions
  • Rising Demand for Reverse Shoulder Implants

Challenges

  • Post-Surgery Complication
  • Shortage of Trained Surgeons

Companies Mentioned

  • Exactech, Inc.
  • Johnson & Johnson
  • Wright Medical Group N.V.
  • Zimmer Biomet Holding Inc.

For more information about this report visit http://www.researchandmarkets.com/research/zqp9z6/global.

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
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Related Topics: Orthopedic Devices