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New Self-Tensioning DYNACORD Suture Launches in Key European Markets
Innovative Design of DYNACORD Suture to Help Address Loss of Tension and Gap Formation Observed with Use of Orthopaedic Sutures
ZUCHWIL, SWITZERLAND – 17 June 2020 – The Johnson & Johnson Medical Devices Companies* announced today that the DePuy Synthes** Mitek Sports Medicine division, a leading developer of sports medicine products and soft tissue repair devices, now offers DYNACORD Suture in select European markets. The high-strength, self-tensioning DYNACORD Suture is intended to be used in procedures such as soft tissue approximation in rotator cuff repairs.
Unlike other high-strength orthopaedic sutures which may experience laxity, DYNACORD Suture is specifically designed to shorten when compression is lost, thereby minimizing gap formation.1,2 Through axial contraction, DYNACORD Suture has been shown in pre-clinical testing to mitigate suture laxity, creep, knot slippage or the loss of compression due to load spikes.‡ 1,4,5
“The idea of a suture that minimizes tissue gapping and gently improves tendon-to-bone contact was born based on observations during daily practice such as loss of suture tension immediately after tying and/or after inadvertent overload episodes during early rehabilitation. I believe that DYNACORD Suture and its innovative technology could help address unmet needs in soft tissue repairs,” said design surgeon Prof. Dr. med. Ralph Hertel of the Shoulder and Elbow Center, Bern, Switzerland.†
Rotator cuff tears are a common cause of shoulder pain and dysfunction amongst athletes and the aging population. In fact, in 30% to 70% of shoulder pain cases, the pain is related to disorders of the rotator cuff, and the incidence of rotator cuff tears varies between 5% and 40%.6 In rotator cuff repairs, which are intended to reduce pain and restore function, shoulder surgeons reattach the tissue to the upper arm utilizing sutures and anchors. However, structural failure of the repair occurs in a substantial number of cases and can lead to an unsatisfactory result. One meta-analysis of more than 8,000 rotator cuff repairs showed a mean re-tear rate of 26.6%.7 Furthermore, the revision rate for large to massive rotator cuff tears has been reported to be as high as 90%.8
DYNACORD Suture was designed to address the key goals of an ideal rotator cuff repair, including higher initial fixation strength, contact area and contact pressure at the tendon-bone interface, minimal gap formation, and sustained mechanical stability.8 The suture consists of two outer sheaths of braided fibers and a core comprised of silicone and salt, and when it is used in a repair, the salt particles within the silicone core dissolve, leaving behind a porous structure. These small voids then fill with surrounding fluid as the core hydrates, causing the braided sheath to expand outward and the suture to shorten in length if there is a loss in tension, thereby reducing laxity and helping to maintain footprint compression.
“The self-tensioning aspect of DYNACORD Suture is a great advancement. Maintaining suture tension protects my repairs from laxity and helps the suture stay in place for longer periods of time,” said Emilio Calvo, M.D., Head of the Department of Orthopedic Surgery and Traumatology and Professor of Orthopedics at Fundación Jiménez Díaz in Madrid, Spain.† 1,3
Compared to a leading Ultra-High Molecular Weight Polyethylene (UHMWPE) suture tested, DYNACORD Suture also delivers superior knot security and 28% lower abrasiveness for a more secure repair.‡ 4,9 Furthermore, in an in-vivo ovine tendon repair model, self-tensioning resulted in no strangulation nor necrosis of tissue.‡ 3
“The European launch of DYNACORD Suture demonstrates our ongoing commitment to introducing innovative solutions for sports medicine surgeons to help make continued advancements in the field of soft tissue repair,” said Wulf Radermacher, European Lead for DePuy Synthes Mitek Sports Medicine, Synthes GmbH. “Our core objective is to continue to create innovative soft tissue repair solutions designed to equip orthopaedic surgeons with trusted and versatile choices to help them improve patient care.”
DYNACORD Suture is now available in select markets in Europe, the Middle East and Africa. The suture is offered in conjunction with HEALIX ADVANCE Anchors, as well as in free-strand form with and without needles.
About Johnson & Johnson Medical Devices Companies
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopaedics, vision and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.
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 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.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding DYNCORD Suture. 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, any of the other Johnson & Johnson Medical Devices Companies 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 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, 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, the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, vision and interventional solutions businesses within the Johnson & Johnson's Medical Devices segment.
**DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
†Paid consultant to DePuy Synthes, Inc.
‡Animal and bench testing results may not necessarily be indicative of clinical performance
1 DePuy Synthes. Approximation Force Design Verification Report. Ref# 103394861.
2 DePuy Synthes. Compression Study. Ref# 103653516.
3 Favorito P. J., et al. Safety evaluation of a laxity-minimizing suture at 5 days and 6 weeks after repair of a sheep infraspinatus tendon. J Shoulder Elbow Surg. 2019 Jan;28(1):164-169.
4 DePuy Synthes. Bench-top test results. Results of Knot Security Evidence Generation Study. Ref# 103412391.
5 DePuy Synthes. Results of Cycling Load Evidence Generation Study. Notebook 2017-06 page 86,89. Notebook 2017-11 page 19,51.
6 Oliva F, Piccirilli E, Bossa M, et al. I.S.Mu.L.T - Rotator Cuff Tears Guidelines. Muscles, Ligaments and Tendons Journal. 2015 Oct-Dec;5(4):227-263. DOI: 10.11138/mltj/2015.5.4.227.
7 McElvany, D., McGoldrick, E., Gee, A., Neradilek, M., and Matsen, F. Rotator Cuff Repair: Published Evidence on Factors Associated with Repair Integrity and Clinical American Journal of Sports Medicine. Published online 21 April 2014.
8 Yeh ML, et al. Current Biomechanical Concepts of Suture Bridge Repair Technique for Rotator Cuff Tear. International Journal of Orthopaedics 2015;23(3):284-288.
9 Owens, B., Algeri, J., Liang, V., and DeFroda, S. Bench-top test results. Rotator cuff tendon tissue cut-through comparison between 2 high–tensile strength sutures. Journal of Elbow and Shoulder Surgery. https://doi.org/10.1016/j.jse.2019.02.028. Published 10 May 2019.
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