Rotator Cuff Tear Arthropathy

MINNEAPOLIS, Oct. 24, 2024 /PRNewswire/ -- Inovedis Inc., a cutting-edge medical technology start-up, has announced a major milestone in soft tissue repair with the first U.S. patients receiving treatment using their revolutionary SINEFIX™ Rotator Cuff Repair System. This breakthrough system aims to transform the approach to rotator cuff surgery by addressing not just biomechanical fixation, but the critical role of blood flow in tendon-to-bone healing. Rotator cuff repairs have historically been plagued by high failure rates despite advancements in surgical techniques. Many traditional methods focus on strengthening the fixation of the tendon to the bone, but new findings suggest that overemphasis on fixation might actually hinder the healing process. The key lies in minimizing tension and evenly distributing pressure over the largest possible contact surface between tendon and bone, promoting better circulation and biological healing. "Rotator cuff surgery requires biomechanical stability, but excessive tension can compromise blood flow and slow healing," explained Dr. Brian Cohen, an orthopedic surgeon involved in the U.S. launch of SINEFIX™. "Despite improved fixation methods, retear rates remain high. The SINEFIX™ implant controls compression without straining the tendon, preserving blood flow and potentially setting a new standard in rotator cuff repair." The SINEFIX™ system, designed for tendon ruptures up to 2 cm, features a simplified two-step process using a PEEK plate and two PEEK anchors, equipped with additional teeth to prevent tendon slippage. This design keeps the tendon vital by maintaining blood circulation, which is essential for biological healing. The system eliminates the need for complex suture management, making it a more accessible technique for surgeons and improving patient outcomes. "Rotator cuff repair surgeries are among the most common soft tissue procedures, with over half a million performed each year in the U.S. alone," said Dr. Stefan Welte, co-founder of Inovedis and inventor of the SINEFIX™ system. "Unfortunately, traditional methods using suture anchors have not yielded significant improvements in patient recovery. Our vision is to revolutionize biomechanical fixation and enhance biological healing. The success of these first cases in the U.S. brings us closer to that goal." Tom Anstead, CEO of Inovedis Inc., emphasized the importance of the technology in reducing surgery time and cost while enhancing patient care. "The simplicity of SINEFIX™'s surgical technique, which eliminates the need for knot tying, is a critical step toward making this groundbreaking technology available to surgeons worldwide. Our first successful cases in the U.S. mark a significant achievement for our team." As Inovedis continues to pioneer advancements in orthopedic repair, the introduction of SINEFIX™ represents a potential turning point in the treatment of rotator cuff injuries, offering new hope for improved recovery and long-term healing. ABOUT INOVEDIS Inovedis is a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions. Since its founding in 2019, Inovedis has been developing SINEFIX™ to simplify rotator cuff tear surgery and improve patient outcomes. SINEFIX received FDA clearance in 2023. SINEFIX is not approved for sale outside the U.S. To learn more, visit our website and follow us on LinkedIn. MEDIA CONTACT: Ronda Taylor [email protected] SOURCE Inovedis Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Researchers have developed a python-tooth-inspired device as a supplement to current rotator cuff suture repair, and found that it nearly doubled repair strength. Their biomimetic approach following the design of python teeth helps to reattach tendons to bone more securely. The device not only augments the strength of the repair but can also be customized to the patient. Most people, when they think about pythons, visualize the huge snake constricting and swallowing victims whole. But did you know that pythons initially hold onto their prey with their sharp, backward-curving teeth? Medical researchers have long been aware that these teeth are perfect for grasping soft tissue rather than cutting through it, but no one has yet been able to put this concept into surgical practice. Over the years, mimicking these teeth for use in surgery has been a frequent topic of discussion in the lab of Dr. Stavros Thomopoulos, a professor of orthopedics and biomedical engineering at Columbia University. Biomimicry key to new study A leading researcher focused on the development and regeneration of the tendon-to-bone attachment, Thomopoulos is particularly interested in advancing tendon-to-bone repair, necessary for rotator cuff repair and anterior cruciate ligament reconstruction. In a paper published today by Science Advances, his team reports that they have developed a python-tooth-inspired device as a supplement to current rotator cuff suture repair, and found that it nearly doubled repair strength. "As we grow older, more than half of us will experience a rotator cuff tear leading to shoulder pain and decreased mobility," said Thomopoulos, who has joint appointments at Columbia Engineering and Columbia's Vagelos College of Physicians and Surgeons as the Robert E. Carroll and Jane Chace Carroll Professor of Biomechanics (in Orthopedic Surgery and Biomedical Engineering). "The best medical intervention is rotator cuff surgery, but a remarkably high percentage of these repairs will fail within just a couple of months. Our biomimetic approach following the design of python teeth helps to reattach tendons to bone more securely. The device not only augments the strength of the repair but can also be customized to the patient. We're really excited about the potential of our device to improve the care of rotator cuff injuries." Rotator cuff injuries Among the most prevalent tendon injuries, rotator cuff tears affect more than 17 million people in the United States each year. The incidence of injury increases with age: more than 40% of the population over 65 years old experience a rotator cuff tear. Because rotator cuff tears typically occur at the tendon-to-bone insertion site, rotator cuff repair is aimed at anatomically restoring the tendon attachment. Surgical repair is the primary treatment for restoring shoulder function, with more than 600,000 procedures performed annually in the United States at a cost of $3 billion. However, successfully reattaching tendon to bone remains a significant clinical challenge. High failure rates occur following surgery, with rates increasing with patient age and tear severity. These rates range from 20% in younger patients with minor tears to a staggering 94% in elderly patients with massive tears. The most common failure of rotator cuff repairs is sutures tearing through the tendon at the two or four grasping points where forces concentrate. While there have been advancements in rotator cuff repair techniques over the past 20 years, the fundamental approach of sewing two tissues together has remained largely unchanged, still relying on sutures transferring tension at high-stress grasping points. Following tendon-to-bone reattachment surgery, sutures can tear through tendons at these points of high stress, a phenomenon known as "suture pull-through" or "cheesewiring," leading to repair-site gapping or rupturing. "We decided to see if we could develop a device that mimics the shape of python teeth, that would effectively grasp soft tissues without tearing, and help reduce the risk of tendon re-tearing after rotator cuff repair," said Iden Kurtaliaj, the study's lead author and a former biomedical engineering PhD student in the Thomopoulos' lab. The device The team's original idea was to copy the shape of python teeth, but they went much further, using simulations, 3D printing, and ex vivo experiments on cadavers to explore the relationship between tooth shape and grasping vs. cutting mechanics. Kurtaliaj manufactured a range of tooth designs, optimized individual teeth, arrays of teeth, and finally a rotator cuff-specific array of teeth. The end result was a biomimetic device, made of a biocompatible resin -- an array of teeth atop a curved base -- capable of grasping, not cutting, tendon. The teeth are relatively small -- 3mm high for a human rotator cuff, about half the length of a standard staple -- so that they won't poke through the tendon. The base can be customized via 3D printing to match the patient-specific curvature of the humeral head at the supraspinatus tendon attachment site (the most commonly torn rotator cuff tendon). "We designed it specifically so that surgeons won't need to abandon their current approach -- they can simply add the device and increase the strength of their repair," Kurtaliaj noted. The team Kurtaliaj led the research as a PhD student under the mentorship of Drs. Stavros Thomopoulos and Guy Genin, the Harold and Kathleen Faught Professor of Mechanical Engineering at Washington University in St. Louis, with input for clinical implementation from Dr. William Levine, Chair of the Department of Orthopedic Surgery at Columbia University's College of Physicians and Surgeons. "Due to our laboratory's close collaboration with orthopedic surgeons, we were especially fortunate to get input from Dr. Levine, along with other surgeons at Columbia, throughout the device's design development process," said Thomopoulos. Next steps The researchers are now working to develop a bioabsorbable version of the device that would degrade as the rotator cuff heals back to bone, further enhancing its clinical applicability. They are also preparing for a pre-submission meeting with the FDA to facilitate the transition of their device into the market.

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it will sponsor tennis players participating in The Championships, Wimbledon 2024 to spotlight its advanced Sports Medicine portfolio alongside some of the greatest athletes in the world. Smith+Nephew endeavours to help people live their ‘Life Unlimited’ by aiding in their recovery from injury and get them back to doing what they love. Click to play video - Smith+Nephew Proud Player Sponsor at The Championships, Wimbledon 2024 Tennis is an elegant sport but can be rough on the body – especially to a player’s joints. Two common injuries1,2 that tennis players suffer are rotator cuff tears in the shoulder and meniscus tears in the knee. Smith+Nephew offers advanced solutions for both of these injuries that are supported by clinical evidence and time-tested results. Smith+Nephew’s comprehensive Advanced Healing Solutions portfolio is redefining biological healing in rotator cuff repair. Backed by 10 years of clinical evidence and more than 100,000 procedures completed globally since its introduction in 2014, the REGENETEN Bioinductive Implant has had a transformative impact, offering a better solution for more than 1 million3 patients having surgery for a rotator cuff tear each year. The collagen-based implant supports the body’s natural healing response to facilitate the formation of new tendon-like tissue to biologically augment the existing tendon and change the course of rotator cuff tear progression.4-10 Smith+Nephew also has an established track record of success in knee repair including a 30-year legacy of saving the meniscus rather than removing it. One of the most frequently published meniscal repair devices on the market, the FAST-FIX◊ Family of meniscal repair solutions has helped surgeons repair hundreds of thousands11 of meniscal tears over the past 30 years due to its ease of use,12 high fixation strength,*13-16 and strong, reliable repairs.17-19 With an 88% mean success rate of all-inside repairs,20 the FAST-FIX Family has truly helped patients return to a Life Unlimited. “Both Smith+Nephew and the players participating in Wimbledon share a common thread as leaders in their respective fields and being among the best at what they do,” said Christie Van Geffen, Senior Vice President of Global Marketing for Sports Medicine at Smith+Nephew. “It’s an honour to sponsor players competing in this year’s Championship and we look forward to helping athletes all over the world get back to performing at the highest level.” If you would like to find out more about Smith+Nephew’s leading Sports Medicine technology portfolio – including the REGENETEN Bioinductive Implant and FAST-FIX Family of meniscal repair solutions – please visit www.smith-nephew.com. - ends – Media Enquiries Dave Snyder +1 (978) 749-1440 Smith+Nephew david.snyder@smith-nephew.com *As demonstrated in biomechanical testing References Dines, JS et al. Tennis Injuries: Epidemiology, Pathophysiology, and Treatment. J Am Acad Orth Surg. 2015;23(3):181-189Majewski M et al.Epidemiology of athletic knee injuries: A 10-year study. The Knee. 2006;13(3):184-188iData Research. Rotator cuff repair and reconstruction market size, share and trends analysis (2023). Available at: https://idataresearch.com/product/rotator-cuff-repair-reconstruction-market-size-share-and-trends-analysis-global-2023-2029-medsuite-includes-grafts-allografts-xenograft-synthetic-and-1-more/#. Accessed December 19, 2023.Ruiz Ibán MA, Navlet MG, Marco SM, et al. Augmentation of a transosseous equivalent repair in posterosuperior non-acute rotator cuff tears with a bioinductive collagen implant decreases the re-tear rate at one year. A randomised controlled trial. Arthroscopy. Published online 12/27/2023.Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J. 2016;6(1):16-25.Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study. J Shoulder Elbow Surg. 2018 27(2):242-251.Van Kampen C, Arnoczky S, Parks P, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: a histological evaluation in sheep. Muscles Ligaments Tendons J. 2013;3(3):229-235.Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283Bokor DJ, Sonnabend DH, Deady L, et al. Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up. Muscles, Ligaments Tendons J. 2019;9(3):338-347.McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA, 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2):491-500.Internal Smith+Nephew sales data from 2023 FY STGP RMSmith+Nephew 2015.Ver/Val, Protocol/Report, FAST-FIX 360 Delivery System. Internal Report. 15000994 Rev. E.Smith+Nephew 2004. Suture performance in standard arthroscopic knots - Effects of material and design. Internal Report. 1061539 Rev. A.Smith+Nephew 2007. Internal Test Request - ULTRA FAST-FIX. Internal Report. ITR-3457.Smith+Nephew 2010.The biomechanical performance of the FAST-FIX 360 meniscal repair system. Internal Report. DOF 10600596.Smith+Nephew 2007.Evaluation of the mechanical properties of the ULTRA FAST-FIX meniscal repair system in a bovine meniscus model. Internal Report. DOF 10600342Uzun E, Misir A, Kizkapan TB, et al. Evaluation of Midterm Clinical and Radiographic Outcomes of Arthroscopically Repaired Vertical Longitudinal and Bucket-Handle Lateral Meniscal Tears. Orthop J Sports Med. 2019;7(5):1 - 8.Shearman A, Foster A, Wilson A, Risebury M, Yasen S. Excellent medium-term survival of an all-inside tensionable knotted suture device justifies repair of most meniscal tears encountered during reconstructive knee ligament surgery. Knee Surg Sports Traumatol Arthrosc. 2020:1-8.Laurendon L, Neri T, Farizon F, Philippot R. Prognostic factors for all-inside meniscal repair. A 87-case series. OTSR. 2017;103(7):1017 - 1020.Johnson, D., Souter, P., Sedgwick, M.. Clinical Performance of an All-inside Meniscal Repair Device: A Systematic Literature Review with Meta-analysis. ISAKOS. 2023. 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