WEST CHESTER, Pa., Oct. 11, 2017 /PRNewswire/ — DePuy Synthes* is launching the MAXFRAME™ Multi-Axial Correction System, an external circular fixation device used to gradually correct bone or soft tissue deformities in the arm, leg, foot or ankle. The MAXFRAME System’s unique 3D planning software helps improve accuracy of the deformity correction plan, which may reduce overall treatment time while potentially improving procedural efficiency and reducing costs. The device represents DePuy Synthes’ commitment to improving patient satisfaction, procedure efficiency and clinical outcomes in deformity correction.

Limb deformities can be congenital, developmental or acquired as the result of fracture, infection, arthritis or tumor. Left uncorrected, these deformities may lead to amputation and could have a potential cost burden of $500,000ⁱ per patient to the healthcare system. External circular fixation products currently on the market require precise X-rays and manual measurements by surgeons, and any inaccuracies can prolong treatment. Patients suffering from limb deformities may require an average of 37 outpatient visits over 12 months,^{ii iii} and one in three patients will experience a residual deformity.^iv

Unlike other computer-assisted external circular fixation systems, the MAXFRAME System’s 3D planning software creates accurate patient treatment plans using advanced algorithms, which eliminates the need for manual measurements and requires fewer inputs than any other system on the market. This can potentially lead to a reduction in the number of patient X-rays required, thus reducing procedural complexity, radiation exposure for both the patient and surgeon, and overall costs, while reducing treatment time for the patient.

Patients undergoing treatment with the MAXFRAME System are responsible for adjusting the struts on the device as per their custom treatment plan. These adjustments have been made easier with the system’s newly introduced ASSURE-STRUT™ Technology, wherein each time the patient adjusts the device, there is an audible click as the strut correctly locks into place.

“The MAXFRAME System incorporates three clinically important advantages that help provide great accuracy of correction for the patient and streamline the surgical phase of care,” said Dr. J. Spence Reid, MD, Professor and Chief of Trauma Division, Department of Orthopaedics and Rehabilitation. “The software eliminates significant sources of error inherent in earlier methods by removing the need to determine reference ring mounting parameters, as well as the requirement of ring orthogonality. The system also allows maximum flexibility in the location of strut attachment points on the ring which makes frame application easier, particularly in complex cases, and the ASSURE-STRUT™ Technology allows the patient to confidently make strut adjustments.”

MAXFRAME Patient Care Program
To support patients, DePuy Synthes has developed the MAXFRAME Patient Care Program, which includes a patient app featuring a character named “MAX,” and additional online content is available at www.maxframepatients.com. The program helps patients and their caregivers prepare for surgery, manage treatment and share their experiences through social media channels at the end of their treatment journey.

“There is a significant unmet need for treatment options that reduce both the burden to patients with limb deformities as well as surgical complexity,” said I.V. Hall, Worldwide Platform Leader, Trauma, CMF, Biomaterials and Veterinary Portfolios, DePuy Synthes. “With the launch of the MAXFRAME System, we are building on our long history of innovation, excellence in service and support for surgeons with unique 3D planning software and digital tools that help address these needs and enhance patient and surgeon satisfaction.”

Product Indications
The MAXFRAME System is indicated for the following treatments in adults and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed), pseudoarthrosis of long bones, limb lengthening (epiphyseal or metaphyseal distraction), joint arthrodesis, infected fractures or nonunions, correction of bony or soft tissue deformities, and correction of segmental defects.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies**, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes Companies 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

ⁱ MacKenzie EJ, Jones AS, Bosse MJ, et al. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. The Journal of bone and joint surgery. American volume. Aug 2007;89(8):1685-1692.
ⁱⁱ Lerner J, Holy CE, Menzie A. Cost of post-operative care after implantation of multiplanar stereotactic-assisted external fixation systems. Poster presented at: 21^st Annual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Meeting, May 21-25, 2016; Washington, DC, USA.
ⁱⁱⁱ Fenton P, Bose D. Patient-reported outcomes following treatment of tibial non-union with circular frames. Strat Traum Limb Recon. 2014;9(1):33-5.
^iv Kucukkaya M, Karakoyun O, Armagan R, Kuzgun U. Calculating the mounting parameters for Taylor Spatial Frame correction using computed tomography. Journal of orthopaedic trauma. Jul 2011;25(7):449-452

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its subsidiaries.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

DSUS/TRM/1017/1620

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

10 Oct 2017 – By Nextremity

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World” Warsaw, IN, is announcing the limited release of its newest product, the Axi+Line™ Proximal Bunion Correction System for the treatment of hallux valgus deformity, also known as a bunion. This announcement comes shortly after Nextremity Solutions announced the limited release of another new product, the PiroVue™ Gastrocnemius Recession System for the treatment of equinus deformities in patients.

According to a 2015 study in Foot & Ankle International^® entitled, “A New Measure of Tibial Sesamoid Position in Hallux Valgus in Relation to the Coronal Rotation of the First Metatarsal in CT Scans”, patients with hallux valgus deformities (bunions) had a “more pronated first metatarsal than the control group”. The study showed that 87.3% of the patients sampled with hallux valgus deformity also had abnormal frontal plane rotation of the first ray.

Nextremity Solutions currently offers the Re+Line^® Bunion Correction System, which specifically focuses on the treatment of hallux valgus deformities of lesser angles. However, the Axi+Line Proximal Bunion Correction System addresses treatment of deformities of larger angles and addresses correction in the frontal plane.

READ THE REST HERE

Vancouver, BC — (ReleaseWire) — 10/05/2017 –According to a new series of reports on the U.S. market for orthopedic small bone and joint devices by iData Research (www.idataresearch.com), elbow open reduction internal fixation (ORIF) is growing due to the use of anatomic plates which are low profile designed specifically for the olecranon, coronoid and distal humerus. The fastest growing procedure of the elbow is complete replacement which is prescribed in cases of arthritis, fractures which cannot be managed using other techniques and for revision of the elbow. The elbow repair market is segmented by primary elbow and radial head implants with a combined market value in the U.S. of just under $50 million in 2016.

“Radial head implants are primarily used for traumatic fixation, as degeneration of radial head articulation is not a frequent occurrence,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “Fractures of the radial head typically result from falls on outstretched hands; therefore, the demand for these products increases as the population ages.”

The primary elbow implant market is sub-segmented into semi-constrained and unconstrained devices. The majority of unit sales are semi-constrained due to greater durability and the higher complication rate of unconstrained devices. Only Wright Medical’s Latitude™ EV Total Elbow Prosthesis can be installed unconstrained and, of those devices, just under half are done this way. The radial head market meanwhile, is the fastest growing segment with both units sold and ASP expected to grow over the next several years.

Zimmer Biomet is the leading competitor in the U.S. elbow repair market. They have experienced strong growth in the past few years and offer a full range of products for the orthopedic elbow surgeon. Zimmer Biomet’s Coonrad-Morrey total elbow product has a long history in the market with over 25 years of clinical use, set the standard for primary elbow replacement. The Coonrad-Morrey is the most popular primary elbow joint replacement in the world and is designated for rheumatoid arthritis, osteoarthritis and fractures.

READ THE REST HERE

ENGLEWOOD, Colo., Sept. 26, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach and facilitate reproducible results that benefit both the surgeon and patient.

The addition of Posterior Plates to the Gorilla® Ankle Fracture Plating System further expands Paragon 28’s robust foot and ankle specific portfolio.  The Gorilla® Ankle Fracture Plating System now offers surgeons 44 total plates in seven families to address distal fractures of the fibula and tibia.  The Posterior Plates are offered across four families and provide surgeons 20 unique options to address fractures of the tibia and fibula from a posterior approach.

Paragon 28 Gorilla® Ankle Plating System – Posterior Plates

Posterolateral Fibula Plate

• Narrower in design than the anatomic and straight fibular plates to allow for better fit when placed on the posterior and posterolateral surfaces of the fibula
• Distal screw configuration is oriented to avoid anatomic structures when used with a lateral or posterior incision
• Can also be used as an anti-glide plate in order to buttress the distal fragment from shifting proximally

Posterolateral Tibia Plate

• Contoured to match the anatomy of the posterior tibia
• The two most distal screw holes are angled superiorly to avoid the concave surface of the tibia
• Lateral plate placement helps avoid Flexor Hallucis Longus (FHL) tendon

Posteromedial Tibia Plate

• Designed for a posterior pilon variant fracture
• Contoured to match the anatomy of the posterior tibia

Trimalleolar Fracture Plate

• Designed for the posterior malleolar fracture of a trimalleolar fracture
• Plate has a slight concavity to minimize the need for interoperative bending to match the posterior tibia
• Plate is designed to prevent superior translation of the fracture fragment, as an anti-glide concept

Paragon 28 is grateful for the significant contributions Dr. Christopher Zingas, MD, Dr. John Kwon, MD and Dr. Michael Houghton, MD made as the surgeon designers of this system.

Product Page:
http://www.paragon28.com/products/ankle-fracture-plating-system/

CONTACT: Jim Edson, Director of Product Management and Marketing, jedson@paragon28.com

SOURCE Paragon 28

PLAINSBORO, N.J., Sept. 21, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced the first Cadence^® Total Ankle System has been implanted by Dr. David Pedowitz with the Rothman Institute in Philadelphia, Pennsylvania in the Cadence Total Ankle System non-randomized, prospective, multi-center post-market study.

“While this patient represents only one of many who have already benefited from the Cadence Total Ankle System, she is the first of my patients who will be a part of this important study, documenting the unique benefits of this new system in terms of ease of use, patient satisfaction, and survivability,” said Dr. David Pedowitz.

The primary objective of the study is to evaluate 2-year implant survivorship in subjects who received the Cadence Total Ankle System for primary ankle arthroplasty. Implant survivorship will further be evaluated at 5 and 10 years post-operatively. All patients in the study will receive the Cadence Total Ankle System.

About Cadence
Cadence Total Ankle System, is a new ankle prosthesis developed in partnership with four world leading foot and ankle surgeons – Dr. Tim Daniels (University of Toronto, Toronto, Canada), Dr. David Pedowitz (Rothman Institute, Philadelphia, Pennsylvania), Dr. Selene Parekh (Duke University, Durham, North Carolina) and Dr. Christopher Hyer (Orthopedic Foot & Ankle Center, Westerville, Ohio). To date, more than 350 Cadence total ankle procedures have been successfully performed in seven countries.

The Cadence system has garnered positive feedback among its users for advancements in implant and instrument design, along with a streamlined surgical technique. Cadence incorporates several features to accommodate various patient anatomies, reduce potential clinical complications, and address common challenges associated with ankle arthroplasty procedures. Key implant features include:

• Side-specific, anatomical tibial components, designed to avoid fibular impingement.
• Side-specific, anatomical talar components, designed to minimize resected talar bone and to preserve vascularity in the ankle.
• Bearing insert components manufactured from a highly crosslinked ultra-high molecular weight polyethylene (HXL UHMWPE) for improved wear characteristics, and patent pending-biased sagittal profile options to address patients with subluxed talar anatomy.

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.

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, 2016 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.

Integra LifeSciences Holdings Corporation

Investor Relations Contact:

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

Media Contact:

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

CHARLOTTE, N.C., Sept. 18, 2017 (GLOBE NEWSWIRE) — Two Charlotte, N.C.-based orthopedic hand surgeons are pioneering new amputee surgeries that are offering patients unparalleled use of their upper extremities. OrthoCarolina hand surgeons Glenn Gaston and Bryan Loeffler are performing and developing multiple new surgical techniques for upper extremity amputees, including Targeted Muscle Reinnervation (TMR), which transplants nerves and allows them to reinnervate, or grow into, another muscle. TMR surgery enables nerve signals that have been transferred into a new muscle to control prostheses as a normal human arm would, using nerve impulses sent directly from the brain.

One of Dr. Gaston and Loeffler’s most recent and notable TMR patients is 32-year old mother of three Tiffany Johnson who lost her right arm when she was bitten by a shark while snorkeling off the coast of the Bahamas in June. The surgeons amputated Johnson’s arm just below the elbow joint. With badly damaged muscles and skin, the surgeons’ challenge was to keep the amputation below the elbow to ensure functional and sustained use of the limb. They transferred nerves that controlled the hand from the severed limb to another part of the arm, reinserting those nerves into another muscle. In their new location Johnson’s nerves can function as they would have previously. She is in the process of learning to use her new myoelectric hand, which is controlled by signals from her brain.

“Reassigning nerves to another part of the limb allows a patient easier control of their prosthesis and can also significantly reduce the phantom pain often felt by amputees,” said Dr. Gaston. “Even when a limb is gone, nerves are still available for the body to use.”

Drs. Loeffler and Gaston are developing other innovative forms of TMR by adapting the principles to other parts of the body including the forearms and legs. They also completed the first surgery for the prosthetic hand with individual finger control in 2016.

Beyond TMR, the doctors are leading experts in other advanced nerve reconstruction surgeries for adults and children with spinal cord injuries as well as brachial plexus injuries. They lead the the OrthoCarolina Reconstructive Center for Lost Limbs, a multidisciplinary clinic intended to help upper extremity amputees by offering patients the latest surgical innovations and technology to help them restore maximum limb performance and live life to the fullest. Cutting-edge techniques and surgeries include targeted muscle reinnervation, the STARFISH procedure (developed by the OrthoCarolina Hand Center), and flexion osteotomies to improve prosthetic fit and control.  The Clinic coordinates with local and regional prosthetists and utilizes the most advanced myoelectric prostheses available.

“By coming to the clinic individuals who have amputations can meet with multiple healthcare providers and address variety of daily challenges that affect their lives, including general health and wellness, mobility, independence and more,“ said Dr. Loeffler. “It is also a chance for patients to meet others who have their same injuries or who have had similar surgeries, which goes a long way in dealing with the emotional part of their injury.”

Drs. Gaston and Loeffler have recently received awards from the American Academy of Orthopaedic Surgeons (AAOS) and have spoken at numerous international meetings about their work in the field of upper extremity reconstruction for amputees. Read more at orthocarolina.com.

About OrthoCarolina
With expert physicians and care providers in locations throughout our region, OrthoCarolina is one of the nation’s leading orthopedic practices and your destination for comprehensive orthopedic care. Our expertise in the areas of foot and ankle, hand, hip and knee, shoulder and elbow, spine, sports medicine and pediatrics to offer a continuum of care unmatched in our region — and throughout the country.

OrthoCarolina. You. Improved.

Connect with OrthoCarolina at orthocarolina.com or on Facebook, Twitter and YouTube.

Contact:
Logan Stewart
704.323.2486
logan.stewart@orthocarolina.com