STEMI - ST elevation myocardial infarction

CÚRAM SFI Research Centre for Medical Devices researchers have published in Nature Communications a key study establishing a new pre-clinical model to develop clinically relevant treatments for heart attacks. This research resulted from an established collaboration of CÚRAM with European institutions in Italy (University of Milano-Bicocca), France (University of Paris Est Créteil), Sweden (University of Gothenburg) and Lithuania (Lithuanian University of Health Sciences). Heart attacks (myocardial infarction (MI)) occur due to an acute complication of coronary artery disease and are a major cause of global mortality. The two main types of heart attack are ST-elevation (STEMI) and Non-ST elevation (NSTEMI). A non-ST-elevation is a type of heart attack that usually happens when your heart's oxygen needs are unmet. This condition gets its name because it doesn't have an easily identifiable electrical pattern like with an ST elevation that can be read from an electrocardiogram (ECG). Currently, preclinical models of heart attack mimic only full-thickness STEMI and hence cater only for an investigation into therapeutics and interventions directed at the NSTEMI subset of heart attack. In this new study, researchers have developed a preclinical model of NSTEMI by adopting a novel surgical procedure that closely resembles the complexity of clinical cases in humans. Researchers validated the presented model by comparing it with an established method to achieve STEMIs. They performed a detailed analysis at the main acute and late time points after the induction of NSTEMI, at 7 and 28 days, respectively. Dr Paolo Contessotto and Dr Renza Spelat said: "Advanced analyses on the affected heart tissue highlighted a distinctive pattern of alterations in the tissue, especially in the sugar moieties (glycans) which compose cardiac cell membranes and extracellular matrix (the network of proteins and other molecules that surround, support, and give structure to cells and tissues in the body). Identifying such changes in molecular elements that can be accessed and treated with injectable drugs sheds light on how we can develop targeted pharmacological solutions to correct these changes." Professor Abhay Pandit, CÚRAM Scientific Director and senior author of the study, said: "There is a need in the field to adopt clinically relevant models to study NSTEMI pathophysiology and reveal its functional differences with STEMI induction. This new model will facilitate the translation of future research in the field, enabling the discovery of new clinically relevant treatments for patients." Dr Mark Da Costa, Clinical Investigator at CÚRAM and senior author of the study, said: "Currently, NSTEMI is the most common presentation of acute heart attack. The concern is that NSTEMI patients have lower in-patient (during their admission for the primary NSTEMI) and short-term mortality rates but significantly higher long-term mortality than those of STEMI patients. A Danish registry study of 8,889 patients showed that the 5-year mortality after NSTEMI was 16%, and another registry study highlighted a 10-year survival rate of only around 50%. To the best of our knowledge, there are currently no models that can reproduce both the functional and histological characteristics of NSTEMIs. This novel model may specifically serve as a preclinical foundation to study interventions that could combat the short and long-term effects of NSTEMI." Ends Notes for editors Link to complete manuscript: Nature Communications volume 14, Article number: 995 (2023) This study was funded by the European Commission funding under the AngioMatTrain 7th Framework Programme (Grant Agreement Number 317304) and by the research grant from Science Foundation Ireland (SFI) co-funded under the European Regional Development Fund under Grant Number 13/RC/2073 and13/RC/2073_P2 to A.P

KIRKLAND, Wash.--( BUSINESS WIRE )-- Cardiac Dimensions ®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the appointment of Angie Swenson as Vice President of Clinical Operations. Ms. Swenson has spent most of the last 20 years leading clinical trials in the U.S., Europe, Japan and Canada and collaborating on reimbursement strategies for therapies targeting cardiovascular disease developed by leading medtech innovators. Most recently, she served as Vice President, Clinical and Regulatory for HLT, Inc., developer of transcatheter aortic heart valve replacement (TAVR) technology, where for five years she led their early feasibility studies. Prior to that, she was an Associate Director of Clinical Research for C.R. Bard subsidiary Lutonix, overseeing global clinical trials for its drug coated balloons for angioplasty. As Clinical Director for therapeutic hypothermia firm Velomedix, she managed all aspects of a multicenter pilot study of its technology in acute STEMI patients. For St. Jude Medical, she handled overall management of a large multicenter heart valve clinical trial supporting FDA clearance and approvals in Europe, Australia, Canada and Japan, as well as post-market heart valve and renal denervation studies. Earlier in her career, she worked for Beckman Coulter as a Clinical Studies Scientist validating projects for FDA submissions. Her broad experience also includes serving as a medical technologist for Cardiac BioMarkers Trial Lab managing cardiac in vitro diagnostics trials for external sponsors, and as a medical technologist for Hennepin County Medical Center. She holds a Bachelor of Science degree in Medical Technology from Minnesota State University and a certificate in Clinical Trial Management from the University of Chicago Graham School. “Angie’s rich experience in the successful planning and execution of clinical trials and approvals for medtech therapies addressing important valvular and other cardiovascular diseases is ideally suited to our innovative therapy for mitral valve disease,” said Cardiac Dimensions CEO Rick Wypych. “We look forward to benefitting from her insights and expertise as we focus on enrolling the U.S. pivotal EMPOWER Trial of our Carillon™ Mitral Contour System and exploring reimbursement strategies to support it.” About the Carillon Mitral Contour System Cardiac Dimensions is reimagining the solutions available to patients suffering from heart failure by providing a therapy that allows patients to live longer, higher quality lives. Our product, the Carillon Mitral Contour System , is a groundbreaking, non-surgical, minimally invasive device developed to treat patients with mitral valve insufficiency. The Carillon therapy is the only indirect, no-touch mitral valve repair option designed to produce an annuloplasty effect while initiating left ventricular remodeling and improving long-term survival for patients. The Carillon therapy can also be used alongside other heart failure treatments should they be needed. To date, thousands of patients have been treated with the Carillon system throughout the world. Positive safety and performance data on Carillon therapy encompassing more than 350 patients has been published from four previously completed studies and a real-world registry of the Carillon system. Additionally, the pivotal EMPOWER Trial of the Carillon system is currently enrolling patients in the U.S., as well as in select centers worldwide. The EMPOWER Trial is a randomized, blinded, sham-controlled study of a broad population of patients with heart failure caused by early- through late-stage mitral regurgitation defined as MR grades 1-4. Upon FDA approval, it would be the only medical device solution commercially available as front-line therapy for earlier-stage MR patients with MR grade 1-2 not adequately managed with medications. The Carillon Mitral Contour System has obtained the CE Mark and Therapeutic Goods Approval (TGA) and is approved for sale in Australia and Europe. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com . About Cardiac Dimensions Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, secondary mitral regurgitation contributes to heart failure, a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon system addresses the underlying mechanical problem of secondary mitral regurgitation with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany. Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.

CHELMSFORD, Mass.--(BUSINESS WIRE)-- ZOLL, an Asahi Kasei company, announced today that the first patient has enrolled in the REAL SSO2 post-market observational study to assess the clinical utility and cost-effectiveness of TherOx SuperSaturated Oxygen (SSO2) Therapy compared to PCI alone in standard of care treatment for ST-elevation myocardial infarction (STEMI) patients. The first patient was enrolled by the interventional cardiology team at St. Mary’s Medical Center in West Virginia, led by site investigator Mehiar El-Hamdani, MD and study coordinator Cheryl Kane, RN. SSO2 Therapy is used immediately after stenting is performed for left-anterior descending (LAD) STEMI heart attacks — the most severe type — and within six hours of symptom onset. SSO2 delivers high levels of dissolved oxygen directly to the heart to recover damaged tissue. Data have shown that SSO2 Therapy is associated with lower rates of heart failure and death within one year,1 and it is the only therapy approved by the FDA to reduce infarct size.2 The REAL SSO2 study is a prospective, real-world multi-center, post-market observational study enrolling 750 patients, including both SSO2-treated and control subjects. The study is intended to further demonstrate the clinical and economic value of SSO2 Therapy and evaluate post-event interventions, rehospitalization, and quality of life measures. The real-world data will be collected from the site enrollments in addition to case data from the American College of Cardiology (ACC) CathPCI patient registry. A complete overview of the study can be found on ClinicalTrials.gov. “SSO2 Therapy is the newest treatment modality in improving care for STEMI patients, and we are thrilled to be leading this study aimed at demonstrating value beyond the acute clinical benefits,” said Robert Yeh, MD, co-principal investigator and interventional cardiologist at Beth Israel Deaconess Medical Center. “Given the significant reduction in infarct size already demonstrated through previous clinical studies,1 we expect to see longer-term improvements in this patient population as compared to primary percutaneous intervention (PCI) alone.” In addition to Dr. Yeh, the study’s co-principal investigator is David Cohen, MD, Director of Clinical Outcomes & Research at Cardiovascular Research Foundation in New York, NY. “The REAL SSO2 study is an important step towards positioning SSO2 Therapy as a standard of care,” said Christopher Barnabas, President of ZOLL Circulation. “ZOLL is pleased to partner with top institutions and the ACC on this research, and we believe the study outcomes will further demonstrate the positive impact SSO2 Therapy can have for patients who suffer severe heart attacks.” About ZOLL ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit . About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit . Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit . Copyright © 2023 ZOLL Medical Corporation. All rights reserved. TherOx and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation and/or its subsidiaries in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners. 1 Stone, G.W. et al. Circ Cardiovasc Interv; 2; 366-375. Sep 2009. 2