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

Soft Tissue Regeneration Raises Series C Financing and Rebrands to Biorez

Biorez, Inc., formerly known as Soft Tissue Regeneration, Inc., today announced the close of a $1.5 million investment following preliminary results of the first in-human study of its novel implant for anterior cruciate ligament (ACL) reconstruction.

The breakthrough approach makes use of a proprietary tissue-engineered scaffold that stabilizes the knee, facilitates the body to regrow new ACL tissue, and then fully resorbs, leaving only new, functional tissue.

Connecticut Innovations, Connecticut’s leading source of financing and ongoing support for Connecticut’s innovative, growing companies, led the investment round. Vertical Group and KLP Ventures, an affiliate of Launch Capital, also participated in the round.

“Biorez has learned a great deal through their early stages of development and testing,” said Dan Wagner, managing director at Connecticut Innovations, and a Biorez board member. “With a new CEO at the helm and a new path ahead, we look forward to supporting the progress of this company and technology in the future.”

“Typically, a torn ACL is surgically reconstructed using a tissue graft harvested from the patient or a cadaver,” said Kevin Rocco, CEO of Biorez. “Neither option is ideal for patients, but both biologic grafts remodel into new functional tissue over time. We have developed an off-the-shelf, synthetic scaffold constructed from biocompatible polymers that harnesses the same regenerative remodeling process.”

Biorez will be sharing the detailed results of the human trial in private meetings with key partners, surgeons, and researchers during the American Association of Orthopedic Surgeons (AAOS) meeting in San Diego, from March 14 through March 18, 2017. Biorez is the first company to clinically investigate a tissue-engineered scaffold for ACL reconstruction in a human trial.

“The clinical study has validated our unique approach, and given us a first-mover advantage to further optimize our technology,” said Rocco. “We look forward to publishing our results.”

About Biorez, Inc.
Biorez, Inc. is a privately-held, early-stage regenerative medicine company engaged in developing bioresorbable scaffold implants to regenerate functional tissue in vivo. Its lead product candidate is an off-the-shelf implant for ACL reconstruction that spares harvesting of patient donor-tissue, and provides a better alternative to cadaver-based materials. The company plans to commercialize its lead ACL technology, as well as expand its platform to develop new and innovative clinical solutions. To learn more, visit http://www.biorez.com.

DePuy Synthes Companies Announces New ATTUNE® Revision Fixed Bearing Tibial Base and Cemented Stem

SAN DIEGO, March 15, 2017 /PRNewswire/ — Today, DePuy Synthes*, part of the Johnson & Johnson Family of Companies, announced the launch of the first ATTUNE® Knee revision options, the ATTUNE Revision Fixed Bearing Tibial Base and the 14×50 mm Cemented Stem. The Tibial Base is designed to address a range of patient needs, from complex primary to partial revision of ATTUNE Primary Knees. The announcement was made in San Diego, coinciding with the American Academy of Orthopaedic Surgeons Annual Meeting.

The ATTUNE Revision Fixed Bearing Tibial Base, which is compatible with either fixed bearing posterior stabilized or cruciate retaining tibial inserts, incorporates the proprietary technologies of the ATTUNE Knee such as the LOGICLOCK™ Tibial Base locking mechanism that is designed to enable enhanced kinematics, stability and wear reduction.1 The ATTUNE Revision Fixed Bearing Tibial Base can be used with a 14×50 mm Cemented Stem that can be added intra-operatively at the discretion of the surgeon for patients with clinical needs that require supplemental fixation.

According to Rajit Kamal, Global Knee Platform Leader, DePuy Synthes Joint Reconstruction, “DePuy Synthes worked with renowned experts around the world to develop the ATTUNE Knee System. The ATTUNE Revision Fixed Bearing Tibial Base and Cemented Stem were developed to address more complex clinical needs and expand treatment options for patients. It will also extend DePuy Synthes leadership in the category of revision solutions.”

DePuy Synthes Companies developed the ATTUNE Knee System to improve the stability and motion of knee replacement, which are important to patient satisfaction. The ATTUNE Knee System can help patients return to their normal activities sooner than anticipated2-3, while also enabling surgeons and health systems to improve clinical outcomes, reduce costs and increase patient satisfaction.

Implant survivorship data from the 2016 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) confirmed positive early results for the primary ATTUNE Knee.4 These data add to other recent registry evidence which has shown that survivorship for the primary ATTUNE Knee compares favorably to other knee systems in its class.5 In addition, one-year results from two worldwide studies have shown improved patient reported outcomes measures with the primary ATTUNE Knee compared to other leading knee systems.6

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive portfolios of orthopaedic solutions in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, neurological, 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.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the effectiveness and value of the ATTUNE Knee System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns for health care products and services; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements”, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

*DePuy Synthes presents the products and service of DePuy Synthes, Inc. and its affiliates

The third-party trademarks used herein are trademarks of their respective owners
DSUS/JRC/0217/2035 March 2017

References:

1. Leisinger, S., Hazebrouck, S., Deffenbaugh, D., Heldreth, M. (2011) Advanced fixed bearing TKA locking mechanism minimizes backside micromotion. International Society for Technology in Arthroplasty (ISTA) Annual Meeting.

2. Clatworthy, M. (2015). An Early Outcome Study of the ATTUNE® Knee System vs. the SIGMA® CR150 Knee System. DePuy Synthes Companies White Paper. DSUS/JRC/0814/0418.
In an IRB approved early outcomes study, physiotherapists collected data on 40 patients implanted with ATTUNE® Knees and 40 patients with SIGMA® CR150 knees. The results demonstrated that patients implanted with the ATTUNE Knee had statistically significant improvements in some early outcomes, other outcomes demonstrated a trend favoring the ATTUNE Knee, and some outcomes were equivalent

3. Etter, K., Lerner, J., de Moor, C, Yoo, A., Kalsekar, I. (2016). PMD10-Comparative Effectiveness of ATTUNE® Versus Triathlon™ Total Knee Systems: Real-World Length of Stay and Discharge Status.” Value in Health 19(3): A298.
Premier Perspective™ Database analysis including 38 hospitals, representing 1,178 primary, unilateral TKAs with the ATTUNE Knee and 5,707 primary, unilateral TKAs with Triathlon™. The analysis found that the patients implanted with the ATTUNE Knee had statistically shorter length of stay and were more frequently discharged home vs. a skilled nursing facility compared to the TKAs with Triathlon™.

4. Australian Orthopaedic Association National Joint Replacement Registry Annual Report. (2016). Tables KT9 and KT22. Retrieved from: https://aoanjrr.sahmri.com/documents/10180/275066/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty

Smith & Nephew previews NAVIO™ Robotics-assisted Total Knee Application at AAOS ahead of full market release in Q2 2017

LONDON, March 14, 2017 /PRNewswire/ — Smith & Nephew (NYSE: SNN; LSE: SN), the global medical technology business, today announces the upcoming full market release of its NAVIO hand-held robotics-assisted total knee arthroplasty (TKA) system. Smith & Nephew will be hosting live hands-on demonstrations for surgeons at the 2017 Annual American Academy of Orthopaedic Surgeons meeting in San Diego, CA, March 15-17 (booth # 5133).

The NAVIO Surgical System total knee application is expected to enter full market release in the second quarter of 2017, 510(k) pending, with Smith & Nephew’s JOURNEY II, LEGION and GENESIS II Total Knee Systems.

The NAVIO robotic-assisted total knee application is designed to deliver consistent and accurate results through the utilization of a surgeon controlled robotics-assisted hand piece, coupled with NAVIO specific cut guides. This unique combination yields an intuitive and efficient workflow for the entire surgical team.  In addition, the versatile NAVIO planning software enables precise implant alignment and ligament balance, without the need for a pre-operative CT scan.  Eliminating the dependency on pre-operative imaging allows the surgeon to seamlessly plan for either a unicompartmental or total knee procedure at the time of surgery.

“I have experience with several robotic systems and my experience with the NAVIO Surgical System has been phenomenal. Both NAVIO UKA and TKA applications allow me freedom as a surgeon, unlike other robotic options, because it is imageless. I can easily plan and correct for significant deformities and retained hardware with confidence. I love the direct interface with the system itself, putting me back in control.

Additionally, the cost of the system including the capital investment, lack of advanced imaging and its portability make it affordable for both hospitals and ASCs”  says Jimmy Chow, M.D,  Director of Orthopaedics: Hip & Joint, Phoenix St. Luke’s Medical Center.

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 more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE: SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

 

SOURCE Smith & Nephew

Related Links

http://www.smith-nephew.com

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

BONESUPPORT™ Founder Lars Lidgren Receives the 2017 OREF Clinical Research Kappa Delta Award

Lund, Sweden, 16 March, 2017 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces that its founder Lars Lidgren, is a member of a  group of Swedish and US Knee and Hip surgeons from Lund and Gothenburg, Sweden, Boston and Rochester U.S. that has received the 2017 OREF Clinical Research Kappa Delta Award. The award was made for the group’s outstanding research contribution leading to improved prosthetic survival and patient outcomes.

The OREF Clinical Research Kappa Delta recognizes outstanding clinical research related directly to musculoskeletal disease or injury. Henrik Malchau, MD, PhD, part of the Swedish and US group, will present the study “Arthroplasty Implant Registries Over The Past Five Decades: Development, Current and Future Impact” The award will be given at the AAOS meeting, San Diego, California on Thursday, March 16 at 11:00 am in the Ballroom 20.

Lars Lidgren, M.D., Ph.D. Hon. Member AAOS., founder of BONESUPPORT, said: “I’m delighted that clinical research on joint replacements, one of the most common surgical procedures today, has gained this very prestigious award. I am confident that our long term research based on arthroplasty registries will continue to help shape the development of new innovative technologies to provide patients with improved orthopaedic outcomes.”

 

Contact Information

Citigate Dewe Rogerson

David Dible, Andrea Bici, Mark Swallow

+44 (0)20 7282 2949/1050/2948

bonesupport@citigatedr.co.uk 

Notes to Editor 

About the OREF Clinical Research Kappa Delta Award 

This award recognizes outstanding clinical research related directly to musculoskeletal disease or injury. Eligible applicants must be members of the American Academy of Orthopaedic Surgeons, the Orthopaedic Research Society, the Canadian Orthopaedic Association, and the Canadian Orthopaedic Research Society. The winning paper is presented by the author at the Orthopaedic Research Society’s annual meeting, and the award is presented to the recipient by an OREF representative at the Academy’s annual meeting during the Kappa Delta Award presentations.

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ is a registered trademark.

 

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.
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New Report Demonstrates The Clinical And Economic Value Of The ATTUNE® Knee System In Today’s Value-Based Environment

SAN DIEGO, March 14, 2017 /PRNewswire/ — Today, DePuy Synthes*, part of the Johnson & Johnson Family of Companies, released a new report, “Improving the Value of Primary Total Knee Arthroplasty: the ATTUNE® Knee System,” that analyzes the ATTUNE Knee’s current clinical and economic data. The report concludes that in a value-based healthcare environment with cost constraints and growing procedure volumes, the value of a knee replacement implant is measured not only by how long the implant lasts (implant survivorship), but also through patient reported outcomes and the economic benefits of the procedure.

The report, which was released alongside the American Academy of Orthopaedic Surgeons Annual Meeting in San Diego, is authored by David Fisher**, M.D., Director of the Total Joint Center of Excellence at OrthoIndy Hospital in Indianapolis, Indiana, and Professor David Parkin, an Honorary Visiting Professor at City, University of London and a Senior Visiting Fellow, Office of Health Economics.

The report analyzes approaches for evaluating primary total knee arthroplasty (TKA) from a clinical and health economic perspective, and assesses the current data from DePuy Synthes’ ATTUNE Knee Evidence Generation Program. This program, the largest of its kind in DePuy Synthes’ history, includes a wide range of data from company-initiated studies, investigator-initiated studies, independent studies and national joint registries.

In their analysis, Dr. Fisher and Professor Parkin conclude that, “Based on available data, the ATTUNE Knee appears to be advancing outcomes for patients and creating value for clinicians, providers and payors in a challenging and dynamic healthcare environment.”

Click to Tweet: New @DePuySynthes report released today demonstrates the clinical and economic value of the ATTUNE® Knee System #AAOS17 http://bit.ly/2mjUTL8

This report comes at a time when the entire episode of patient care is a major focus for global healthcare providers, placing a laser-like focus on both improving patient outcomes and managing costs. The bundled payments program in the United States and the “Payments for Results” system in England are two examples of the drive to minimize the total cost of care while maintaining quality. Against this backdrop, data from a comprehensive evidence generation program can help provide evidence to support decisions about a device’s overall value.

“The success of any knee replacement is multifactorial, and the data on the ATTUNE Knee gives me confidence that I’m using a knee replacement that is delivering value for patients and the healthcare system,” said Dr. Fisher.

Added Professor Parkin: “Quality of life, as measured by patient reported outcomes, has been shown to be a driver of cost effectiveness in knee replacement. The evidence that I’ve seen about the effectiveness of the ATTUNE Knee in improving patient reported outcomes suggests it can deliver a better quality of life for patients compared to other leading knee systems. Therefore, the ATTUNE Knee may potentially play a role in helping reduce some of the healthcare and societal costs associated with knee osteoarthritis.”

According to the analysis, the ATTUNE Knee has thus far demonstrated favorable survivorship, improved patient reported outcomes versus other knee systems, as well as potential economic benefits:

  • Survivorship: The published report from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) showed that the ATTUNE Knee’s estimated cumulative percent revision was 1.39% at three years (98.61% survivorship) for 4,463 knees, comparing favorably to the class of Cemented Total Knee Arthroplasty that has an estimated cumulative percent revision of 1.50%1. In addition, per the 2016 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), in which 4,831 ATTUNE Knees are being tracked, the ATTUNE Knee’s estimated cumulative percent revision was 0.5% (ATTUNE Cruciate Retaining Knee) and 0.4% (ATTUNE Posterior Stabilized Knee) at one year.2 This compares favorably to the overall class of cemented TKA at one year, which has an estimated cumulative percent revision of 1.0 percent.
  • Patient Reported Outcomes: DePuy Synthes has taken the lead in this area by helping generate and validate a new measure, the Patient’s Knee Implant Performance (PKIP), to specifically assess the functional status of a patient’s knee from their own perspective. Results of a study using PKIP as well as other commonly used generic and condition-specific patient reported outcome measures showed that, at one year, study participants implanted with the ATTUNE Knee had statistically significant improvements compared to other leading knee systems in terms of confidence in stability during activity, decreased anterior knee pain, activities of daily living and quality of life.3
  • Health Economics: A U.S. hospital database analysis showed 39% lower odds of patient discharge to a skilled nursing facility when implanted with an ATTUNE Knee, compared to patients who received total knee replacement with a Triathlon® Knee.4 This may potentially impact patient satisfaction and reduce healthcare costs. Post discharge costs are a significant portion of the overall episode of care. One study showed that up to 35% of episodic costs were related to post hospital discharge care5 and another showed it was up to 50%.6

To read this report and learn more about ATTUNE Knee Evidence, visit www.ATTUNEevidence.com.

About DePuy Synthes Companies
DePuy Synthes Companies, part of the Johnson & Johnson Family of 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.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the effectiveness and value of the ATTUNE Knee System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns for health care products and services; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including in the sections captioned “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements”, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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

**Consultant to DePuy Synthes Companies

The third party trademarks used herein are the trademarks of their respective owners.

DSUS/JRC/0217/2031 March 2017

References:

1

National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, 13th Annual Report. (2016). Table 3.24

(a). Available from: www.njrreports.org.uk

2

Australian Orthopaedic Association National Joint Replacement Registry Annual Report. (2016). Tables KT9 and KT22. Retrieved from:
https://aoanjrr.sahmri.com/documents/10180/275066/Hip%2C%20Knee%20%26%20Shoulder%20Arthroplasty

Medtronic Announces New Bone Cement Indication for Treating Sacral Fractures

DUBLIN – March 14, 2017 – Medtronic plc (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon(TM) Xpede Bone Cement for fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty – expanding the product’s indications beyond treatment of vertebral fractures due to osteoporosis, cancer or benign lesions.

Sacral insufficiency fractures (SIFs) are a common cause of debilitating lower back pain in the elderly, with incidence ranging from 1 to 5 percent in at-risk populations.1,2 According to the National Osteoporosis Foundation, about 54 million Americans have osteoporosis and low bone mass, placing them at increased risk for a fracture. Breaking a bone is a serious complication of osteoporosis, especially with older patients. Osteoporotic bone breaks are most likely to occur in the hip, spine or wrist, but other bones can break, too – including the sacrum.3

“Sacral insufficiency fractures are associated with a tremendous amount of pain and debilitation for individuals who have them,” said Dr. Douglas Beall, chief of Radiology Services at Clinical Radiology of Oklahoma. “Having this new indication with Kyphon Xpede Bone Cement to use in the treatment of sacral fractures will help to address this patient population.”

A recent multi-center retrospective study of 243 patients with osteoporotic SIFs treated with sacroplasty reported significant pain relief for patients immediately following the procedure and after one-year follow-up; authors indicated that there were no major complications or procedure related deaths. The study reported a low procedure-related complication rate with 1 of 243 subjects (0.4 percent) having symptomatic leakage requiring decompression.2

“We are pleased to expand our therapies for interventional physicians treating osteoporotic patients to include those suffering from sacral insufficiency fractures,” said Jeff Cambra, general manager of the Interventional Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic. “As the pioneers in balloon kyphoplasty for treating vertebral compression fractures, this expanded indication for Kyphon Xpede Bone Cement demonstrates our long-term commitment to continuously innovate and empower physicians to deliver the best clinical solutions to their patients.”

Kyphon Xpede Bone Cement is a quick-to-dough bone cement that provides ease of handling and allows sufficient time for careful, minimally invasive use. When paired with the Kyphon(TM) Cement Delivery System, clinicians can minimize their radiation exposure by standing up to four feet away from the radiation source during injection, which has been measured to reduce hand radiation exposure by 70 percent.4

About Sacral Insufficiency Fractures
Sacral insufficiency fractures (SIFs) are a common cause of debilitating back pain. SIFs mimic the symptoms of lumbar spine pathology and are commonly missed or underdiagnosed. Since the sacral ala is composed predominantly of cancellous bone – the first to be reduced in cases of osteoporosis and other metabolic conditions – it remains the most common region for SIFs.1,2

About Kyphon Xpede Bone Cement
Kyphon Xpede Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.

Risks of acrylic bone cements include cement leakage which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as:

  • Cardiac arrest
  • Cerebrovascular accident
  • Myocardial infarction
  • Pulmonary embolism
  • Cardiac embolism

Payer coverage for sacroplasty may vary. Medtronic recommends providers review all payer coverage policies and/or call payers to determine coverage criteria and appropriate coding.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Balloon kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.

-end-

  1. Sudhir G., et al. Sacral Insufficiency Fractures Mimicking Lumbar Spine Pathology. Asian Spine J 2016;10(3):558-564
  2. Kortman K, et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. 2013 Sep 1;5(5):461-6.
  3. National Osteoporosis Foundation Website. www.nof.org
  4. Medtronic data on file. The mean radiation reduction at the hands was 77.79 percent (p<0.001). Based on an internal testing of 24 total cadaveric procedures (n=12 using Kyphon(TM) CDS and n=12 using Kyphon(TM) Bone Filler Device). Dosimeters were placed on the wrist and fingers to measure radiation when delivering bone cement into the vertebral body. Radiation result reported is based on adherence to the Directions for Use.

Contacts:
Victor Rocha
Public Relations
+1-901-399-2401

Ryan Weispfennig
Investor Relations
+1-763-505-4626

Corin Group Launches Optimized Positioning System (OPS™) for Hip Replacement at AAOS

SAN DIEGO, March 14, 2017 /PRNewswire/ — Every patient moves differently, and now surgeons can take this into account when performing hip replacement surgery thanks to a new technology from Corin Group that helps determine the best positioning of an implant and its components based on how patients really move during daily activities.

Corin announced the U.S. launch of its Optimized Positioning System (OPS™) System at the American Academy of Orthopaedic Surgeons (AAOS) in San Diego. The technology may lead to one of the most significant changes to the way hip replacements are performed in more than 30 years.

“This new technology challenges the traditional approach of placing implants in generic safe zones,” said James Huddleston III, MD, associate professor of orthopaedic surgery at the Stanford University Medical Center. “Now we can get more specific and tailor the implant position for each patient. This should help reduce the dislocation rate and even possibly reduce wear.”

Utilizing pre-operative functional simulation and planning and a unique intra-operative positioning system that employs 3D printing and laser guidance, OPS helps surgeons determine the best position and orientation for a hip implant based on specific patient anatomy and movement.

“While hip replacement surgery is considered one of the most successful operations in medical history, we are always looking for ways to improve it, particularly ways we can improve function and performance and reduce the potential for dislocation and premature wear of bearing surfaces,” said Douglas Dennis, MD, an orthopaedic surgeon in Denver, CO. “This new technology may be an advance that helps us do this.”

In the U.S., the first-ever functional, patient-specific hip replacement procedures using OPS were performed in November 2016, shortly after FDA clearance. More than 3,000 procedures have been done in Europe and Australia, where the system was previously approved for use.

“No two patients are the same. We are offering a patient-specific solution that gives the surgeon the information and tools necessary to enable an optimal hip replacement procedure,” said Paul Berman, President Corin USA. “Feedback from surgeons who have used OPS has been excellent and interest in the system from the orthopaedic community is very high.”

About Corin Group

Corin is a European orthopaedic manufacturer based in the UK that markets its products throughout the world.

Corin is committed to:

…improving patient satisfaction with personalized technologies that optimize our clinically proven joint replacements
…delivering a personal approach to our customers, combining the spirit of our local companies with the strength of our global, integrated organization
…empowering and rewarding our global talented teams to deliver excellence to our customers

For further information about Corin, please visit www.coringroup.com.

This news release contains forward-looking statements. These statements appear in a number of places in this news release and include statements regarding our intentions, beliefs or current expectations, concerning, among other things, our results of operations, turnover, financial condition, liquidity, prospects, growth, strategies, new products, the level of new launches and the markets in which we operate. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ markedly from those in the forward-looking statements as a result of various factors. We undertake no obligation publicly to revise any forward-looking statements, except as may be required by law.

SOURCE Corin USA

Related Links

http://www.coringroup.com