The Latest Cardiac and Vascular News
DISRUPT BTK II one-year outcomes data demonstrate the strong safety profile and consistent effectiveness of the Shockwave Peripheral IVL system to help support wound healing and limb preservation LAS VEGAS, November 3, 2025 – Johnson & Johnson MedTech, a global leader in the field of circulatory restoration, today announced the one-year results […]
–The STORM-PE RCT data presented at the VIVA 2025 Conference showed PE patients treated with CAVT in combination with anticoagulation demonstrated significantly greater improvements in thrombus burden reduction, heart rate, oxygen requirement, and functional outcomes compared to those who received only anticoagulation –Results of STORM-PE demonstrating superior efficacy of […]
PALO ALTO, Calif. and NEEDHAM, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) — Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, announced today that the Company will present data from its anti-CD47 research at the American Heart Association (AHA) Annual Scientific Session 2025, taking place in New Orleans, Louisiana, November 7 – 10, 2025. AHA Abstracts Cardioprotection in a Rat Model of Ischemic Injury by a Novel Anti-CD47 Fusion Protein Presentation: Sa3080 (Heart Failure, Cardiomyopathy & Pulmonary Hypertension)Time: Saturday, November 8th at 10:30am CTPresenting Author: Pierre E. Signore, PhD Anti-CD47 Therapy Induces Early Macrophage-Specific Transcriptomic Changes Associated with the Resolution of Inflammation in a Murine Model of Atherosclerosis Presentation: Su4023 (Genetics and Genomics)Time: Sunday, November 9th at 11:30am CTPresenting Author: Derek Klarin, MD The posters will be available on the Bitterroot Bio website after the presentations. About Bitterroot BioBitterroot Bio, Inc. is a pioneer in the field of cardio-immunology, which investigates the interplay between the immune system and cardiovascular health. Bitterroot Bio’s research seeks to uncover critical roles that immune modulators play in the progression of cardiovascular disease. By targeting these diseases in this novel way, Bitterroot Bio’s mission is to transform the lives of patients suffering from cardiovascular diseases. For more information, please visit https://www.brbio.com or follow us on Facebook LinkedIn, or X. Media Contact: Pablo Fenton (Bitterroot Bio), media@brbio.com
Pivotal trial evaluated the safety and efficacy of the Hēlo™ Thrombectomy System for the removal of blood clots from the lungs MENLO PARK, Calif., Nov. 3, 2025 /PRNewswire/ — Dr. Andrew Klein, ENGULF National Co-Principal Investigator at Piedmont Hospital in Atlanta, today presented the…
Building on the Merck Foundation’s longstanding commitment to advancing access to high-quality health care, new national initiative supports grants to 11 organizations across the country RAHWAY, N.J.–(BUSINESS WIRE)–The Merck Foundation announced today the launch of the Collaborative for Equity in Cardiac Care, a $22 million, five-year initiative aimed at enhancing […]
PROWL Registry evaluates the Pounce™ Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. Updated safety and performance data from 160 patients with symptomatic infrainguinal vessels will be shared. EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in […]
SOUTH JORDAN, Utah, Nov. 03, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced 24-month efficacy findings from the non-randomized AVG cohort of the WAVE trial. Results of the AVG cohort were presented during the Late-Breaking Clinical Trials session at the annual VIVA Foundation3 Venous Endovascular Interventional Strategies (VEINS) conference held in Las Vegas, NV.
NEW HOPE, Pa., Nov. 03, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today announced that company management will host a business update call on Wednesday, November 12th at 8:00 AM ET. The business update will focus on recent significant clinical, strategic and financing developments, including the Company’s additional strategic investment from and collaboration expansion with Medtronic, its new strategic capital relationship with Ligand, its new right of first refusal agreement with Terumo, acceleration of enrollment in the BACKBEAT pivotal study of AVIM Therapy, the initiation of patient enrollment in the Virtue SAB US pivotal IDE coronary trial. Conference Call DetailsWednesday, November 12, at 8:00 AM Eastern Time Toll Free: 877-407-9039International: 201-689-8470Conference ID: 13756518Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1738644&tp_key=c80bc7995c About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind drug delivery angioplasty balloon system designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com
TUCSON, Ariz., Nov. 03, 2025 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first U.S. and Canadian commercially-approved total artificial heart, today announced it will exhibit at the annual meeting of the American Heart Association (AHA) being held November 7th through 10th in New Orleans, Louisiana. At the annual meeting of the AHA, Picard will showcase its SynCardia™ Total Artificial Heart (or “STAH”), which is the most widely used and extensively studied artificial heart in the world, at booth #3408. Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical, Inc. commented, “We are excited to attend the annual meeting of the American Heart Association to share the latest developments related to our innovative and life-saving artificial heart, the Syncardia Total Artificial Heart, or STAH. We look forward to having discussions with physicians and attendees at AHA about patient eligibility, the latest clinical data and helpful resources, and sharing insights from patients who have had real-world experiences with the STAH.” About the American Heart Association (AHA) and its Annual Meeting #AHA25 brings together the full spectrum of cardiovascular science—from foundational science and translational breakthroughs to clinical trials and real-world application. Each year, thousands of professionals come together to exchange ideas, build lasting collaborations, and accelerate progress in cardiovascular health on a global scale. The AHA has grown into the nation’s oldest and largest voluntary organization dedicated to fighting heart disease and stroke. A shared focus on cardiovascular health unites its more than 35 million volunteers and supporters as well as its more than 3,300 employees. Learn more here. The AHA has invested more than $6 billion in research, making it the largest not-for-profit funding source for cardiovascular and cerebrovascular disease research next to the federal government. About Picard Medical and SynCardia Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world. For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov. Forward-Looking Statements This release may contain forward-looking statements within the meaning of federal securities laws. Such statements are based on current expectations and are subject to risks and uncertainties that may cause actual results to differ materially. The Company undertakes no obligation to update or revise any forward-looking statements. Contact: InvestorsEric RibnerManaging DirectorLifeSci Advisors LLCeric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLCIR@picardmedical.com General/MediaBrittany Lanzablanza@syncardia.com
Data to highlight the precision of AI-powered Heartflow Plaque Staging framework in predicting long-term cardiovascular outcomesMOUNTAIN VIEW, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it will present new late-breaking data highlighting the clinical and economic value of Heartflow Plaque Analysis at the American Heart Association (AHA) Scientific Sessions 2025, taking place November 7-10 in New Orleans. The late-breaking Plaque Analysis data evaluate risk prediction with Heartflow Plaque Staging* and will remain under embargo until the featured science presentation, “Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction” on Sunday, November 9, at 12:30 p.m. CST. Timothy Fairbairn, M.D., principal investigator for the FISH&CHIPS study, Liverpool Heart and Chest Hospital NHS Foundation Trust, and Associate Professor at the University of Liverpool, will present the study. With seven abstracts at this year’s AHA Scientific Sessions, Heartflow is significantly advancing the scientific foundation for Plaque Analysis as a key advance guiding cardiovascular risk prediction and personalized treatment. As the established leader in AI-driven coronary care, Heartflow continues to invest in high-quality research to benefit all stakeholders in the healthcare system, fully demonstrating the utility of the Heartflow One platform in transforming CAD into a manageable disease. “Heartflow’s presentations at the AHA Scientific Sessions reflect our ongoing investment in clinical research to validate Plaque Analysis with Heartflow Plaque Staging, empowering cardiologists to personalize treatment plans using non-invasive precision technology,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “By providing AI-driven insights into plaque quantification, we’re helping clinicians see the full picture of coronary artery disease and building more effective pathways for diagnosis, management, and prevention.” Heartflow’s data presentations at AHA will include: Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction Session: Pan Vascular Interventions: Anatomy and Interventions Across Various Vascular BedsPresenter: Timothy Fairbairn, M.D.Date: Sunday, November 9Time: 12:30-12:38 p.m. CSTLocation: Clinical Science Zone 1‚ Moderated Digital Poster 5 Improvements in Diagnostic and Therapeutic Cardiovascular Risk Assessment Through Total Plaque Volume Burden: An Analysis of the FISH&CHIPS StudyFinalist for the Quest Diagnostics Early Career Investigator Award for Preventive Cardiovascular Medicine Research Session: Quest Diagnostics Early Career Investigator Award for Preventive Cardiovascular Medicine Research CompetitionPresenter: Shyon Parsa, M.D., Internal Medicine Resident at Stanford University HospitalDate: Sunday, November 9Time: 10:30-10:40 a.m. CSTLocation: 208-209 Population Changes in AI Coronary Plaque Volumes over 7 Years Session: New Frontiers in Cardiovascular Risk: Trends and Drivers in Cardiovascular Mortality and OutcomesPresenters: Allen Taylor, M.D., F.A.C.C., F.A.H.A., Chairman of Cardiology, MedStar Heart and Vascular Institute and Professor of Medicine at Georgetown University and Matthew Budoff, M.D., Professor of Medicine at the David Geffen School of Medicine at the University of California Los Angeles (UCLA) Medical CenterDate: Saturday, November 8Time: 10:30-11:30 a.m. CSTLocation: Population Science Zone AI-enabled Plaque Phenotype Analysis of Coronary Computed Tomography Angiography Findings in Patients with Nonacute Chest Pain using FFRCT: Results from the PRECISE Trial Session: Imaging Insights from Multicenter Clinical TrialsPresenter: Jonathon Leipsic, M.D., F.R.C.P.C., M.S.C.C.T., Professor and Chair of Radiology and Professor of Cardiology at the University of British ColumbiaDate: Saturday, November 8Time: 11:34-11:39 a.m. CSTLocation: Clinical Science Zone 1‚ Moderated Digital Poster 8 Cost-Effectiveness of AI-Enabled Coronary Plaque Analysis for Management of Stable Coronary Artery Disease Session: Transforming Cardiac Imaging and Risk Assessment Through AIPresenter: Daniel D’Attilio, Director, Healthcare Economics and Outcomes Research, HeartflowDate: Saturday, November 8Time: 12:36-12:41 p.m. CSTLocation: Clinical Science Zone 1‚ Moderated Digital Poster 4 Statin Use Mitigates Androgen Deprivation Therapy-Associated Coronary Atherosclerosis in Prostate Cancer: A Secondary Analysis of the REVELUTION Randomized Clinical Trial Session: Cardiac Amyloidosis and Cardiometabolic ConundrumsPresenter: Marly van Assen, Ph.D., Co-director of the Translational Laboratory for Cardiothoracic Imaging and Artificial Intelligence, Head of CT and AI Research, and Assistant Professor, Emory UniversityDate: Saturday, November 8Time: 2:27-2:32 p.m. CSTLocation: Clinical Science Zone 2‚ Moderated Digital Poster 19 Accelerated Coronary Atherosclerosis Following Relugolix Versus Leuprolide Androgen Deprivation Therapy in Men with Prostate Cancer (REVELUTION): An Open-Label Randomized Controlled Trial Session: Where Cancer and Cardiovascular Disease Collide: Risks, Disparities, and Evolving EvidencePresenter: Marly van Assen, Ph.D., Co-director of the Translational Laboratory for Cardiothoracic Imaging and Artificial Intelligence, Head of CT and AI Research, and Assistant Professor, Emory UniversityDate: Saturday, November 8Time: 3:15-3:20 p.m. CSTLocation: Population Science Zone‚ Moderated Digital Poster 12 Heartflow invites AHA attendees to a Heart Theater Symposium exploring how AI-driven plaque quantification is transforming CAD management: AI-Plaque Analysis: The Paradigm Shift in CAD Management Moderator: Seth Martin, M.D., M.H.S., FAHA, Professor of Medicine and Cardiologist at Johns Hopkins School of MedicinePanelists: Fatima Rodriguez, M.D., F.A.C.C., Section Chief of Preventive Cardiology and Associate Professor in the Division of Cardiovascular Medicine at Stanford University, and Ron Blankstein, M.D., Director of Cardiac Computed Tomography at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical SchoolDate: Sunday, November 9Time: 3:15-4:00 p.m. CSTLocation: Heart Theater 1 *Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework and its safety and effectiveness have not been reviewed by the FDA. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for nearly 500,000 patients worldwide. Key benefits include: Proprietary data pipeline: Built from more than 110 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 96%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, GDPR, HIPAA, CCPA, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com
