Cranial Nerve Injuries

WUXI, China, March 7, 2024 /PRNewswire/ -- Silk Road Medical (NASDAQ: SILK), a medical device company based in California USA and Genesis MedTech Group have signed an exclusive distribution agreement to introduce the TCAR® core products, ENROUTE® Transcarotid Neuroprotection System and ENROUTE® Transcarotid Stent System, in China. TCAR (Transcarotid Artery Revascularization) is an innovative minimally invasive surgical procedure used to treat carotid artery disease, a condition characterized by the narrowing or blockage of the carotid arteries in the neck. This narrowing or blockage can restrict blood flow to the brain and increase the risk of stroke. Since its establishment in 2019, Genesis MedTech Group has continuously strived to enhance its peripheral interventional portfolio, offering comprehensive solutions to both physicians and patients. Through its commercial team and distribution network, patients in China will now have access to the core TCAR products, the ENROUTE® Neuroprotection System and Stent Delivery System. TCAR has shown to reduce the risk of stroke, death, myocardial infraction (MI), and Cranial Nerve Injury (CNI). It is a less invasive procedure with lower rates of procedural complications and an overall improvement in outcomes, contributing to a positive impact on healthcare. Carotid artery disease often occurs in the middle-aged and elderly population, especially among those with atherosclerosis. The condition is characterized by the buildup of plaque, and over time can cause narrowing or blockage of the carotid arteries, affecting blood supply to the brain and leading to diseases such as ischemic stroke. In recent years, stroke has become the second leading cause of mortality worldwide. In China, it now ranks as the primary cause of death and disability. Each year, over 17 million strokes affect individuals over 40 years old. Notably, around one third of ischemic strokes are caused by carotid artery disease. In the United States, TCAR is rapidly replacing traditional procedures. As of the end of 2023, over 85,000 TCAR procedures have been performed. Before the introduction of TCAR, moderate to severe carotid artery disease was generally treated clinically with two surgical methods: Carotid Endarterectomy (CEA) and Transfemoral Carotid Artery Stenting (TFCAS). However, CEA involves a large incision and carries a higher risk of complications, posing a risk of damage to the cranial nerves of patients. Studies have also shown a higher risk of stroke during TFCAS as compared to TCAR and CEA. Based on clinical studies, TCAR is an advancement in the management of carotid artery disease. Professor Chen Zhong, Chairman, Vascular Surgery Group of Chinese Medical Association, President, Vascular Surgery Physicians Branch of Chinese Medical Doctor Association and Chief Physician, Vascular Surgery at Beijing Anzhen Hospital, commented, "There is considerable evidence showing that TCAR offers advantages for patients with symptomatic carotid artery stenosis or those at anatomical or surgical risk." Silk Road Medical's CEO, Chas McKhann stated, "This agreement represents a promising initial step towards expanding the reach of the TCAR therapy with the offering of our ENROUTE Neuroprotection System and Stent Delivery System to more patients worldwide, including those in China. We are very pleased to have partnered with Genesis MedTech, a respected leader in medtech, who shares our vision for the potential impact of TCAR in preventing strokes." "Enabling TCAR to be made accessible to the patients in China certainly marks another milestone in our efforts to bring innovative treatments to our patients. Together with Silk Road Medical, we remain dedicated to make better healthcare more accessible, improving patient care and outcomes." shared Warren Wang, Genesis MedTech Group's Chairman and CEO. ABOUT GENESIS MEDTECH Genesis MedTech Group is a medical device company headquartered in Singapore. Founded by a group of professionals and entrepreneurs with MedTech experience globally, the company's product portfolio focuses on multi-therapy medical device products for emerging markets with sales and distribution through its established commercial network. Genesis MedTech Group covers the entire industry value chain of research and development, production, quality management, supply chain, marketing, and sales. For more information, visit ABOUT SILK ROAD MEDICAL and TCAR Silk Road Medical, Inc. (NASDAQ: SILK), is a medical device company located in Sunnyvale, California, and Plymouth, Minnesota, that is focused on reducing the risk of stroke and its devastating impact. The company has pioneered a new approach for the treatment of carotid artery disease called TransCarotid Artery Revascularization (TCAR). TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. For more information on how Silk Road Medical is delivering brighter patient outcomes through brighter clinical thinking, visit and connect on Twitter, LinkedIn and Facebook. References SOURCE Genesis MedTech

SAN FRANCISCO, Feb. 12, 2024 /PRNewswire/ -- In adolescent athletes who underwent anterior cruciate ligament reconstruction (ACLR), the younger the athlete at the time of primary ACLR and an earlier return to sport (RTS) were significantly associated with an increased rate of secondary ACL injuries, according to new study presented at the 2024 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). The study, " Predictors of Anterior Cruciate Ligament Reinjury and Return to Sport in Adolescent Athletes," found that when the age of primary ACLR increases by one year, the rate of secondary ACL injury decreases by 29% and a one-month delay in RTS decreases the rate of a secondary ACL injury by 17%. "In our practice, we noticed we are seeing a larger prevalence of ACL injuries in this younger population, but we haven't seen literature that specifically looks at the high school age population," said Bhargavi Maheshwer, MD, lead author and third-year orthopaedic surgery resident at University Hospitals in Cleveland, Ohio. "Many of these athletes were returning for revisions or second opinions after having a retear or a contralateral ACL tear, so it is important to outline the trends behind the risk of having an ACL reinjury. Specifically, the variables that are associated with the higher risk of sustaining these injuries and what can we do from a patient education standpoint to address those variables." ACL injuries in adolescent athletes are increasing mainly due to the rise of younger athletes playing in competitive sports at an earlier age and an increased awareness of ACL injuries.[i],[ii] For younger athletes, an ACL injury can have a major impact. For example, there is significant downtime associated with an ACL tear, which may lead to mental health issues, they are 10 times more likely to develop early arthritis, and there is a 25-35% increased risk of experiencing a secondary ACL tear.[iii] Additionally, up to 14% of adolescents who undergo ACLR do not return to their previous level of play.[iv] The researchers sought to identify recent epidemiologic trends of ACL injuries and recurrent tear rates in high school athletes, and determine variables related to sustaining a secondary ACL injury. Using a prospectively maintained database from a single institution, the team retrospectively reviewed data for all patients under the age of 18 who underwent primary ACLR from 2015-2020. Patients were eligible if they were 13-18 years old, participated in a high school sport, and underwent evaluation and primary ACLR at a single institution. To be included, patients had to have a follow-up duration of six months or more and had not undergone a prior revision ACLR. Outcomes included postoperative complications, re-operations, time to RTS (defined as the number of months following ACLR until the patient was cleared to return to the sport by the operating surgeon), and time to retear or reinjury. Odd ratios were calculated for baseline patient characteristics and the association with the risk of retear. Multivariate Cox regression analysis was performed to identify the relationship between retear and potential risk factors. The results included: A total of 431 adolescent patients were included with a median follow up of over five years – 20.2% (87) sustained a secondary ACL injury and 79.8% (344) did not. Nine percent (39) of patients with a secondary ACL injury experienced a graft failure and 11.2% (48) had a contralateral ACL injury (ACL injury on the uninjured knee). Complication rates were low (n=22 6.1%), with 11 patients experiencing arthrofibrosis (3%), one patient (0.2%) with a superficial wound infection managed with antibiotics and one patient (0.2%) with deep infection that required operative irrigation and debridement. Patients with a secondary ACL injury were older than those who did not have another ACL tear (mean age at surgery 16.2 ± 1.3 years versus 15.6 ± 1.5 years, respectively, p=0.003). After adjusting for all variables, a younger age at primary ACLR and time to RTS were significantly associated with an increased rate of secondary ACL injury. "Nine months is the minimum that we consider it safe to return to sport following ACLR as a rapid return to sport puts you at greater risk of a recurrent injury," said James Everett Voos, MD, FAAOS, orthopaedic surgeon, chairman of orthopaedics at University Hospitals and head team physician for the Cleveland Browns. "For our younger athletes, we should take the time to ensure they are fully recovered and have had a chance to rehabilitate since they are often skeletally immature and still growing. As orthopaedic surgeons, we need to customize the treatment plan for each athlete as not all ACLs are the same, and counsel patients about their type of injury and when to return to the sport based on their rehabilitation and age." # # # 2024 AAOS Annual Meeting Disclosure Statement About the AAOS With more than 39,000 members, the American Academy of Orthopaedic Surgeons is the world's largest medical association of musculoskeletal specialists. The AAOS is the trusted leader in advancing musculoskeletal health. It provides the highest quality, most comprehensive education to help orthopaedic surgeons and allied health professionals at every career level to best treat patients in their daily practices. The AAOS is the source for information on bone and joint conditions, treatments and related musculoskeletal healthcare issues; and it leads the healthcare discussion on advancing quality. Follow the AAOS on Facebook, X, LinkedIn and Instagram. SOURCE American Academy of Orthopaedic Surgeons

Final results from inspIRE study demonstrate 80% freedom from atrial arrhythmia recurrence at 12 months in patients with optimal Pulsed Field Ablation applications First look results from admIRE study suggests similar outcomes IRVINE, Calif., Feb. 2, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced 12-month results from the company-sponsored inspIRE study, "Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation (PFA) Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE," presented as a late-breaking presentation at the 29th Annual International AF Symposium.1 Interim results from the company-sponsored admIRE study, titled "PFA Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study," were also shared in a late-breaking presentation.2 Both the inspIRE and admIRE studies were conducted using the Biosense Webster VARIPULSE™ Platform, consisting of the VARIPULSE™ Catheter – a fully integrated variable-loop multielectrode catheter; the TRUPULSE™ Generator – a multichannel PFA generator; and the CARTO™ 3 System VARIPULSE™ Service Pack Software, which provides full integration with the world's leading 3D cardiac mapping system. The CARTO™ System enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms. "Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures," said Jasmina Brooks, President, Biosense Webster, Inc. "The encouraging outcomes from clinical trials with VARIPULSE™ fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation." Data from inspIRE Demonstrate 80% of Patients Achieved Freedom from Recurrence with Zero Primary Adverse Events The inspIRE study evaluated the safety and effectiveness of the VARIPULSE™ Platform for the treatment of drug-refractory paroxysmal AFib in Europe and Canada.1 In the study, the primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AFib, Atrial Tachycardia, or Atrial Flutter) was 75.6%. Among participants receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint.1 The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the VARIPULSE™ Platform to the CARTO™ 3 System. The safety results demonstrated a primary adverse event rate of 0.0%ii.1 "High efficacy of 80% freedom from atrial recurrence at 12 months and a strong safety profile are promising evidence of the capabilities of the VARIPULSE™ Platform," said Vivek Y. Reddy, M.D., Director of Electrophysiology at the Mount Sinai Fuster Heart Hospital and The Helmsley Trust Professor of Cardiac Electrophysiology at the Icahn School of Medicine at Mount Sinai, corresponding author for the inspIRE study publication.iii "As the VARIPULSE™ Platform was designed to integrate seamlessly with the CARTO™ 3 Mapping System, this technology should be able to effectively treat patients with atrial fibrillation with low radiation exposure to patients and lab staff alike." admIRE Pilot Results Show All Pilot Phase Patients Achieved Acute Success and 80% Remained Free from Atrial Arrhythmia Recurrence After One Year Twelve-month outcomes data from the pilot phase of the admIRE study, which assessed the safety and efficacy of the VARIPULSE™ Platform among U.S. patients, were presented as a late-breaker at the AF Symposium.2 Among 20 patients who completed the 12-month follow-up visit, 100% achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.2 No procedure or device-related primary adverse events were reported in the pilot phase of the study.2 For patients who had received ablation, median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively, as a result of the CARTO™ integration.2 "The results observed in the pilot phase of the admIRE study point to the promise of the VARIPULSE™ Platform in treating patients with paroxysmal AFib," said David Newton, M.D., Clinical Cardiac Electrophysiologist, Memorial Health University Medical Center, Savannah, Georgia.iv "These initial results are encouraging and demonstrate the potential for the VARIPULSE™ Platform to become a key component of the suite of tools electrophysiologists have at their disposal to perform catheter ablations." AFib is the most common type of cardiac arrhythmia and affects more than 6 million people in the United States and nearly 38 million people worldwide.3,4 Approximately 1 in 4 adults over the age of 40 are at risk for developing AFib.5 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options, and the importance of early treatment to avoid disease progression.6 Catheter ablation is a safe and effective procedure when drugs don't work to help restore the heart's incorrect electrical signals, which cause an abnormal heart rhythm.7 About inspIRE The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by PFA System With Irreversible Electroporation [IRE]) (NCT04524364) was a prospective, multi-center, single-arm study of drug-refractory PAF, conducted at 13 institutions in Canada and Europe, from March 2021 to May 2022. In the study, PVI was performed with the VARIPULSE™ Platform. Follow up with 24-hour Holter monitoring was performed at three, six, and 12 months. Remote rhythm monitoring was performed weekly from three to five months; monthly, from six to 12 months; and for symptoms. The primary effectiveness endpoint (PEE) was acute PVI plus freedom from all atrial arrhythmia (AFib, Atrial Tachycardia, or Atrial Flutter), at 12 months. This final analysis of the study focused on the pivotal phase (Wave II) per-protocol population of 186 patients with 12 months of follow up. About admIRE The admIRE study (Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the Biosense Webster IRE Ablation System) (NCT05293639) is a prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the VARIPULSE™ Platform when used for isolation of pulmonary veins in treatment of patients in the United States with symptomatic drug refractory paroxysmal AFib. Pulmonary vein isolation (PVI) was achieved using the VARIPULSE™ Platform. The study consisted of a pilot phase, which assessed initial device safety and effectiveness, and a pivotal phase, which assessed these against pre-specified performance goals. The primary safety endpoint was incidence of early onset (within seven days) primary adverse events; atrio-esophageal fistula (within 90 days); cardiac tamponade or perforation (within 30 days); and PV stenosis (within 12 months). Acute procedure success (defined as confirmed entrance block at the end of procedure) and freedom from documented atrial arrhythmia recurrence at 12 months were also assessed. About the VARIPULSE™ Platform The VARIPULSE™ Platform is Biosense Webster's Irreversible Electroporation ablation system. The fully integrated platform includes the VARIPULSE™ Catheter, TRUPULSE™ Generator, and CARTO™ 3 Mapping System VARIPULSE™ Service Pack Software. In January 2024, Biosense Webster announced that the VARIPULSE™ Platform received its first regulatory approval from the Japan Ministry of Health, Labour and Welfare for the treatment of symptomatic drug refractory recurrent paroxysmal AFib using PFA. In the U.S., the VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory authorities. In Europe, the TRUPULSE™ generator received CE mark in late 2023 and VARIPULSE™ Catheter is pending CE mark. About Biosense Webster Biosense Webster, Inc. is the global market leader in the science and technology behind the diagnosis and treatment of cardiac arrhythmias. Part of Johnson & Johnson MedTech, the specialized medical-technology company is headquartered in Irvine, California, and works across the world to advance the tools and solutions that help electrophysiologists identify, treat, and deliver care. Learn more at biosensewebster.com and connect on LinkedIn and X, formerly Twitter. About Johnson & Johnson MedTechii At Johnson & Johnson MedTech,i 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. 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 VARIPULSE™ Platform clinical trials. 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 Biosense Webster, Inc., and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; 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 healthcare products and services; and trends toward healthcare 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 January 1, 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 sec.gov, jnj.com or on request from Johnson & Johnson. None of Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. © Johnson & Johnson Biosense Webster, Inc. 2024. All rights reserved. US_BWI_THER_303927.1 i Johnson & Johnson MedTech comprises the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's MedTech segment. ii Primary adverse events were defined as myocardial infarction, thromboembolism, transient ischemic attack, diaphragmatic paralysis, pneumothorax, heart block, pulmonary edema, vagal nerve injury, pericarditis, major vascular access complication or bleeding, death, stroke, or any other cerebrovascular accident. Atrioesophageal fistula and PV stenosis occurring >7 days post ablation along with cardiac tamponade or perforations occurring within 30 days of the ablation procedure were also considered primary adverse events. iii Nemocnice na Homolce entered into a clinical trial agreement with Johnson & Johnson Medical NV/SA for their participation in the inspIRE Study. Dr. Reddy served as a study coinvestigator. Dr. Reddy was compensated for consultancy purposes for his Multielectrode IRE Catheter Program Study Advisory Committee membership. Dr. Reddy was not compensated for this authorship contributions. iv Memorial HCA Savannah entered into a clinical trial agreement with Biosense Webster, Inc. for their participation in the admIRE Study. Dr. Newton served as a study coinvestigator. Dr. Newton serves as a consultant for BWI. Dr. Newton was not compensated for this authorship contributions. 1 Reddy V, Grimaldi M, Duytschaever M, Anic A. Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE [abstract]. In: AF Symposium.; February 2-4; Boston. 2 Newton D, Natale A, Mansour M, Nair D, Senn T. Pulsed Field Ablation Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study [abstract]. In: AF Symposium.; February 2-4; Boston. 3 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum in: Int J Stroke. 2020 Jan 28;1747493020905964. PMID: 31955707. 4 Kornej J, Börschel CS, Emelia J. Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century. Circulation Research. 2020 June;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340 5 Staerk, et al. 2018 Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ 2018;361:k1453 doi: 10.1136/bmj.k1453 6 Kuck KH, Lebedev DS, Mikhaylov EN, et al. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace 2021;23(3)362-369. doi: 10.1093/europace/euaa298. 7 Natale, A. Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. Journal of the American College of Cardiology, 2014;64(7),647–656. doi: 10.1016/j.jacc.2014.04.072 SOURCE Biosense Webster