SAN DIEGO, June 20, 2018 /PRNewswire/ -- Johnson & Johnson Medical Devices Companies* through the DePuy Synthes** franchise today announces the U.S. launch of DYNACORD Suture to repair soft tissue such as the rotator cuff in the shoulder. Part of the DePuy Synthes Mitek Sports Medicine portfolio, DYNACORD Suture is available on HEALIX ADVANCE Anchors and adds to DePuy Synthes' innovative solutions designed to help address unmet patient needs in soft tissue repair. DYNACORD Suture was launched today at the San Diego Shoulder Institute's 35th Annual Course.
An estimated 25 percent of people over the age of 60 have a full tear of the rotator cuff in which the rotator cuff tendon no longer fully attaches to the head of the upper arm bone.1 The goal of arthroscopic rotator cuff surgery is to reattach the tissue to the upper arm using suture and an anchor. These types of repairs have been shown to reduce pain, improve motion and restore function for patients. However, failure can occur in approximately 20 percent of surgeries2 due to loss of suture tension, which causes gaps to form in the tissue or between the tissue and bone.
To help address complications like these, DYNACORD Suture responds to changes in repair tension that occur over time to promote stability during the healing process. The suture shortens when tension is lost to maintain strong tissue to bone compression, called approximation, throughout the healing period and reduce loss of suture tension and gap formation.
"The scientific support for DYNACORD Suture's safety and effectiveness is solid and the benefit of a suture that can actually take up slack in a repair will help me better serve my patients," said Dr. F. Alan Barber***, orthopaedic surgeon. "I am excited to be able to provide this technology."
This is how DYNACORD Suture performs in the body:
DYNACORD Suture consists of two outer sheaths of braided fibers and a core made of silicone and salt. This internal salt-filled core helps DYNACORD Suture maintain a stable repair environment.
When DYNACORD Suture is placed in the body during surgery, the salt particles within the silicone core dissolve, leaving behind a porous structure within the silicone core.
These small voids are filled with surrounding fluid as the core hydrates, which causes the braided sheath to expand outward, and the suture to shorten in length. This happens if the repair loses tension, to help the suture maintain the stable repair environment throughout the healing process.
"The launch of DYNACORD Suture provides us with a unique opportunity to respond to a very real patient need," said Stephanie Chamberlain, Global Platform Leader Mitek Sports Medicine and Shoulder Reconstruction. "We have a comprehensive portfolio of sutures and anchors for soft tissue repair, and we continue to bring differentiated innovation to the market that can truly address surgeon and patient needs."
DYNACORD Suture on HEALIX ADVANCE Anchors is currently in limited launch in the U.S. with full launch expected in the third quarter of 2018.
About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional solutions and specialty surgery with an offering directed at delivering clinical and economic value to health care systems worldwide.
About DePuy Synthes
DePuy Synthes provides one of the most comprehensive orthopaedics 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.
*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
**DePuy Synthes represents the products and services of DePuy Synthes, Inc. and Medos International.
*** Dr. F. Alan Barber is a consultant to DePuy Synthes Mitek Sports Medicine.
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 DYNACORD 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 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, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company'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 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.
1 Aliprandi, A et al. Reporting rotator cuff tears on magnetic resonance arthrography using the Snyder's arthroscopic classification. World J Radiol 2017 March 28; 9(3): 126-133. 2 Lädermann A, Denard PJ, Burkhart SS. Management of failed rotator cuff repair: a systematic review. J ISAKOS. 2016 Jan;1(1):32-37.