DePuy Synthes Launches The First 3D Simulation Assisted Orthopaedic External Circular Fixation Device For Patients With Limb Deformity

WEST CHESTER, Pa., Oct. 11, 2017 /PRNewswire/ -- DePuy Synthes* is launching the MAXFRAMEtm 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-STRUTtm 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-STRUTtm 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.

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SOURCE DePuy Synthes