Johnson & Johnson
08/29/2024 | Press release | Distributed by Public on 08/29/2024 07:36
DePuy Synthes Launches MatrixSTERNUM™ Fixation System for Enhanced Chest Stability Following Cardiac Surgery
DePuy Synthes Launches MatrixSTERNUM™ Fixation System for Enhanced Chest Stability Following Cardiac Surgery
Innovative system, now available in the U.S., offers strength, speed and contourability,1-4, ‡,§,¶,||#, addressing critical patient need in cardiac procedures3,4
August 29, 2024
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WEST CHESTER, Penn. - August 29, 2024 - Today, DePuy Synthes, The Orthopaedics Company of Johnson & Johnson* and part of Johnson & Johnson MedTech**, announced the launch of the MatrixSTERNUM™ Fixation System, a plate and screw fixation system to help stabilize and secure the front part of the chest wall after procedures like open-heart surgery and chest surgery.5,6 This advanced system is designed to meet patients' needs in the operating room3,4||,§§ by providing stronger locking strength, faster chest fixation, and thinner, low-profile plates as compared to competitive offerings.1-4 ‡,§,¶,||,#
Every year in the U.S., approximately 200,000 people undergo coronary artery bypass graft (CABG) surgery, making it the most common type of heart surgery.7 As the demand for improved chest fixation techniques increases, there is a clear need for innovations that promote better healing, reduce complications and speed up recovery. Recent research indicates that using rigid plates for chest fixation can help lower complications for patients who are at high risk, improve survival rates both during and after surgery and shorten hospital stays.8
"We are committed to developing products that not only meet but exceed the specific needs of heart surgery patients and healthcare providers," said Oray Boston***, Worldwide President, DePuy Synthes Trauma, Extremities, Craniomaxillofacial, Animal Health and Sports. "The MatrixSTERNUM™ Fixation System is a new advancement for post-operative chest stabilization, with stronger, faster and thinner solutions that streamline the procedure and offer surgeons greater flexibility to meet patient needs."
MatrixSTERNUM™ Fixation System delivers three times greater locking strength compared to the market leading product,1‡,§ improving fixation of the sternum during the critical healing period after surgery. Its multi-hole screw guides allow for a more rapid and precise plate fixation process, significantly reducing procedure time.2,3‡,§,|| Additionally, the system features 1.5 mm low-profile plates, which are both thin and highly contourable, making the plates less noticeable under the skin.1#
"After trialing the system, I am quite impressed with how easy it is to use, its intentional and versatile design, and the high quality of the instruments for attaching the plates. I've yet to find another system that allows me to fully plate the sternum in under three minutes," said Dr. Tyrone Galbreath, DO, MHA, FACS, board-certified cardiothoracic surgeon at UT Health East Texas†. "The MatrixSTERNUM™ Fixation System makes it simple to secure the sternal plates, and I am excited to starting using the system when it launches!"
The MatrixSTERNUM™ Fixation System is now available nationwide, offering surgeons a new option for cardiac procedures that supports stabilization following major chest surgeries. For more information on the System, please visit here.
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 healthcare 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 http://www.depuysynthes.com/.
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. For more information, visit https://thenext.jnjmedtech.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 the MatrixSTERNUM™ Fixation 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, Inc., Medical Device Business Services, Inc., 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 Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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. None of either DePuy Synthes, Inc., Medical Device Business Services, Inc., nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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Footnotes
*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, Inc.
***Oray Boston is an employee of Medical Device Business Services, Inc.
† Dr. Tyrone Galbreath, DO, MHA, FACS is a paid consultant for DePuy Synthes.
The third-party trademarks used herein are the trademarks of their respective owners.
Important Information: Prior to use, refer to the instructions for use supplied with the device(s) or indications, contraindications, warnings and precautions.
US_DPS_CMFP_388927
‡Pre-clinical test data/results may not necessarily be indicative of human clinical performance (or outcomes).
§Determined by 7 of 7 surgeons, who evaluated MatrixSTERNUM™ Fixation System in the lab.
¶ Cantilever Bending testing showed that the MatrixRIB™ and MatrixSTERNUM™ Self-Drilling Locking Screws have a higher screw-plate locking strength (203 +/- 2.53 vs. 54.1 +/- 1.45N) vs. the Zimmer Biomet Self-Drilling Locking Screws. Locking screws and plate holes between the relevant plates are identical in MatrixSTERNUM™ Fixation System and MatrixRIB™ System as demonstrated in Engineering Rationale (Windchill#501986434).
|| Seven surgeons and two physican assistants took part in a Time Study, with a total of 17 simulations for the Zimmer Biomet SternaLock® Blu plate and screws construct and 25 simulations for the MatrixSTERNUM™ Fixation System plate and screws construct. Average time to perform fixation steps for MatrixSTERNUM™ Fixation System was 42 ±10 s, and was 76 ±19 s for Zimmer Biomet SternaLock® Blu. Results suggested a reduction of 43% (±15%) to perform fixation steps when using MatrixSTERNUM™ Fixation System with the 8-hole Screw Guides.
# With the exception of Star Plate, which is 1.6 mm thick, MatrixSTERNUM™ Fixation System 1.5 mm plates are thinner than the Zimmer Biomet SternaLock Blu Plates, the KLS Martin Sternal Plating System Plates, and the Stryker SternalPlate System Plates, which ranged from 1.6 - 2.0 mm.
††Determined by 7 of 7 surgeons, who evaluated MatrixSTERNUM™ Fixation System in the lab.
§§Compared to Zimmer Biomet SternaLock Blu, Zimmer Biomet SternaLock EZ and Stryker SternalPlate System, who offer a range of 5 - 12 plates in their portfolio, MatrixSTERNUM™ Fixation System offers 15 plates.
References
1. DePuy Synthes. Engineering Rationale - Comparison of Performance of MatrixSTERNUM Plate-Screw Locking Strength to Competitive Plating System. 17/06/2024. Windchill#501986434.
2. DePuy Synthes. MatrixSTERNUM Human Performance Evaluation - Time Study Protocol. 03/05/2024. Windchill#501503510
3. DePuy Synthes. MatrixSTERNUM Marketing Claims Surgeon Questionnaire Report. 07/05/2024. Windchill#501503525
4. DePuy Synthes. Memo Comparison of MatrixSTERNUM and competitor products. 20/05/2024. Windchill#501983380
5. U.S. Food and Drug Administration. K233967. Indications for Use. 05/09/2024
6. U.S. Food and Drug Administration. K233967. 510(K) Summary. 05/09/2024
7. Jan A, Hayat MK, Khan MAA, Ullah R. Trends in per-operative parameters and postoperative complications associated with coronary artery bypass graft surgery (CABG); A four-year retrospective study. Pak J Med Sci. 2021 Nov-Dec;37(7):1734-1739. doi: 10.12669/pjms.37.7.4315. PMID: 34912387; PMCID: PMC8613026.
8. Tam DY, Nedadur R, Yu M, Yanagawa B, Fremes SE, Friedrich JO. Rigid Plate Fixation Versus
Wire Cerclage for Sternotomy After Cardiac Surgery: A Meta-Analysis. Ann Thorac Surg. 2018;106(1):298-304.
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