Advanced technology from DePuy Synthes offers greater resistance to
intraoperative rod flattening, addressing unmet clinical need for surgeons
RAYNHAM, MASS. – October 14, 2022 – Today, Johnson & Johnson MedTech* announced that DePuy Synthes**, the Orthopaedics Company of Johnson & Johnson, received 510(k) clearance from the Food and Drug Administration (FDA) for its ALTALYNE™ Ultra Alignment System for adolescent spinal deformities, such as scoliosis. Designed to address unmet clinical needs related to intraoperative rod flattening, the ALTALYNE™ Ultra Alignment System offers a 5.5 millimeter profile with 36 percent greater resistance to rod flattening than a standard 6.0-millimeter Cobalt Chromium rod.1
Scoliosis is an abnormal curvature of the spine, and adolescent idiopathic scoliosis (AIS) is the most common spinal deformity in the pediatric population, with worldwide prevalence ranges from 0.47 percent to 12 percent.2,3,4, 5, 6, 7 Surgical treatment of AIS traditionally involves three-dimensional correction with rods and fusion of the spine. A significant challenge associated with the surgical treatment of AIS is intraoperative rod flattening, which can hinder achieving and maintaining the desired corrected spinal contour and restored balance that would enable patients to move more efficiently throughout their day-to-day lives.
Rods with a higher bending yield strength are more resistant to intraoperative flattening, which means the rods can maintain their customized contour and thereby help surgeons achieve the desired restoration for their patients.8 The ALTALYNE™ Ultra Alignment System can deliver greater bending yield strength in a lower profile through advanced material science that employs a specific Cobalt Chromium alloy.1 While this alloy has been used previously in spinal wires, the ALTALYNE™ Ultra Alignment System is the first application of this metal in spinal rods.
“For more than 35 years, DePuy Synthes has been committed to developing products to address urgent and unmet clinical needs in the spinal deformity space,” said Russell Powers***, Worldwide President, DePuy Synthes, Spine. “The ALTALYNE™ Ultra Alignment System was developed based on feedback from pediatric spinal deformity surgeons who told us that intraoperative rod flattening is a significant treatment challenge. With today’s clearance, we can provide surgeons with a new treatment option that uses technologically advanced materials and instrumentation to deliver greater bending yield strength than traditional rods, and most importantly, the potential for better patient outcomes.”
For more information on the ALTALYNE™ Ultra Alignment System and other DePuy Synthes Spine specialty products, visit here.
About Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.
About DePuy Synthes
DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS™ Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide.
Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow. For more information, visit www.depuysynthes.com.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding ALTALYNE™ Ultra Alignment 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; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in the Johnson & Johnson Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other 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.
*Comprising the surgery, orthopaedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
**DePuy Synthes represents the products and services of DePuy Synthes Products, Inc. and its affiliates.
***Russell Powers is an employee of Medical Device Business Services, Inc.
1. DePuy Synthes. Altalyne Calculation of Rod Bending Yield Strength and Stiffness Memorandum, February 11, 2021. Adaptiv #103782175 Rev. 1.
2. US Preventive Services Task Force et al. “Screening for Adolescent Idiopathic Scoliosis: US Preventive Services Task Force Recommendation Statement.” JAMA vol. 319,2 (2018): 165-172. doi:10.1001/jama.2017.19342
3. Tatar O, Ekinci S, Akpancar S, Turgut H. (2016). Current concepts of adolescent idiopathic scoliosis. Minerva Ortop Traumatol 2016, ;67(3):156-62.
4. John P. Horne, R. F. (2014). Adolescent Idiopathic Scoliosis: Diagnosis and Management. Am Fam Physician, 1;89(3):193-198.
5. Konieczny, Markus Rafael et al. “Epidemiology of adolescent idiopathic scoliosis.” Journal of children's orthopaedics vol. 7,1 (2013): 3-9. doi:10.1007/s11832-012-0457-4Choudhry MN, Ahmad Z, Verma R. “Adolescent Idiopathic Scoliosis”. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143.
6. Sung S, Chae HW, Lee HS, Kim S, Kwon JW, Lee SB, Moon SH, Lee HM, Lee BH. “Incidence and Surgery Rate of Idiopathic Scoliosis: A Nationwide Database Study”. Int J Environ Res Public Health. 2021 Aug 1;18(15):8152. doi: 10.3390/ijerph18158152
7. Choudhry MN, Ahmad Z, Verma R. “Adolescent Idiopathic Scoliosis”. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143.
8. DePuy Synthes. EXPEDIUM® Advance Reduction Derotation System Vertebral Body Derotation Spondylolithesis Reduction Fracture Reduction Surgical Technique. 2018. Adaptiv #103407668 Rev. 1.
Manufactured or distributed by:
Medos International Sarl
CH-2400 Le Locl
© DePuy Synthes 2022. All rights reserved.
Please refer to the instructions for use for a complete list of indications, contraindications, warnings and precautions.