The Latest Cardiac and Vascular News
Building on results of the landmark SELECT trial, SCORE shows cardiovascular (CV) risk reduction with use of semaglutide 2.4 mg in a real-world environment1 SCORE is a retrospective, observational analysis of 27,963 patients with obesity or overweight and established cardiovascular…
–Data presented at the American College of Cardiology Annual Scientific Session show that the reduction of bleeding with abelacimab compared to rivaroxaban (Xarelto) was even greater in patients ≥75 years old compared to younger patients –Another analysis from AZALEA-TIMI 71 shows abelacimab, as compared to rivaroxaban (Xarelto), was associated with a greater absolute benefit in patients who are at higher risk for bleeding CAMBRIDGE, Mass., March 29, 2025 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a transformative, clinical-stage biopharmaceutical company developing innovative therapies for the treatment of cardiovascular metabolic diseases, is presenting two new analyses from its landmark AZALEA-TIMI 71 study at the American College of Cardiology Annual Scientific Session (ACC.25) demonstrating the novel Factor XI inhibitor abelacimab significantly reduced bleeding in patients regardless of age or bleeding risk. These data will be presented today during the moderated poster sessions from 2:30-4:30pm CT. In the first analysis, the safety of abelacimab, a novel Factor XI inhibitor, was compared to rivaroxaban, a direct oral anticoagulant (DOAC), by patient age. Inhibition of Factor XI with abelacimab significantly reduced the relative risk of major or clinically relevant non-major (CRNM) bleeding compared with rivaroxaban regardless of age, with potential for greater absolute risk reduction (ARR) with older patients. The ARR in patients 75 years of age and older was 6.2% compared to 4.2% in patients less than 75 years. In addition, abelacimab consistently reduced bleeding risk in patients 75 years of age and older regardless of renal function, body mass index (BMI), and the use of concomitant antiplatelet therapy. “Patients with atrial fibrillation, particularly older patients, are frequently at a high risk of bleeding. There is a need for safer anticoagulants that can prevent thrombotic events while minimizing excess bleeding,” said Christian T. Ruff, MD, MPH, senior investigator of TIMI Group, director General Cardiology, Brigham and Women’s Hospital, and associate professor, Harvard Medical School. “These data show that abelacimab significantly reduced the risk of major or CRNM bleeding, particularly among people over 75 who are vulnerable to such risks, and, if approved, could be a safer alternative for patients needing anticoagulation therapy.” In the second analysis, the safety of abelacimab was compared to rivaroxaban across a spectrum of bleeding risk, which was determined by using the direct oral anticoagulant (DOAC) score, a clinical tool leveraged to assess the risk of bleeding in patients who are prescribed DOACs. In patients with atrial fibrillation, abelacimab reduced rates of bleeding relative to rivaroxaban regardless of bleeding risk, with greater absolute safety benefit in those at higher bleeding risk. In the rivaroxaban arm, the rates of major or CRNM bleeding per 100 patient years increased stepwise across risk categories from 5.6% in the low risk category to 21.2% in the very high risk category. In contrast, the rates of bleeding in patients in the pooled abelacimab arm were 2.5% in the low-risk category to 7.1% in the very high-risk category. The ARR increased from 3.1% in the low risk category to 14.1% in the very high risk category (p-trend for ARR
ATLANTA, March 28, 2025 /PRNewswire/ — MiRus is pleased to announce the launch of the US multi-center Early Feasibility Study of the Siegel™ 8-Fr aortic transcatheter heart valve (THV). The first two cases were successfully performed this week by Pradeep K. Yadav MD, Director of…
OXFORD, England, March 28, 2025 /PRNewswire/ — Ultromics, a pioneer in AI-driven cardiology solutions, has unveiled the latest enhancement to EchoGo® Heart Failure: the introduction of a first-of-its-kind AI-powered probability scoring system for assessing heart failure with preserved…
FORT MILL, S.C., March 26, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced their attendance at three upcoming conferences through April 2, 2025.
NEW YORK–(BUSINESS WIRE)–Powerful Medical, a leader in AI-driven cardiovascular diagnostics, announces that its PMcardio STEMI AI ECG model has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). This designation recognizes PMcardio as a breakthrough technology for the detection of ST-elevation myocardial infarction (STEMI) and STEMI […]
BEIJING, March 25, 2025 /PRNewswire/ — Jenscare Scientific Co., Ltd. (“Jenscare” or the “Company”) (HKEX: 9877), an innovative medical device company with TTVR breakthroughs and is entering commercialization stage for its TAVR (AR) product, released its annual results for year ended…
Coronary Artery Disease (CAD) is the most common heart disease and most frequent cause of death in the U.S., with over 20 million adults affected by this condition Abbott’s investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by using sound…
Robust Evidence of Disease Reversal in Severe Knock Out Mice Model Supports Tenaya’s Clinical Development Plan to Evaluate TN-201 as a Potential Treatment for Patients with MYBPC3-associated Hypertrophic Cardiomyopathy Robust Evidence of Disease Reversal in Severe Knock Out Mice Model Supports Tenaya’s Clinical Development Plan to Evaluate TN-201 as a Potential Treatment for Patients with MYBPC3-associated Hypertrophic Cardiomyopathy
New class, biomimetic TAVR demonstrates sustained hemodynamic performance to one-yearMINNEAPOLIS and BRISBANE, Australia, March 21, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris® or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced one-year results for patients treated with its proprietary, balloon expandable, DurAVR® Transcatheter Heart Valve (THV) System. Rishi Puri, M.D. PhD presented the data at a late breaking clinical trial session at Sydney Valves on Friday 21 March 2025, 10:30am (AEST), titled: “Pioneering a New Class of Biomimetic TAVR with Sustained 1-Year Performance.” One-year Results Highlights: DurAVR® THV demonstrated a favorable hemodynamic profile sustained to one-year, with an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler Velocity Index (DVI) of 0.58.At one-year, clinical safety outcomes show positive results with no valve or cardiovascular related mortality and importantly no prosthesis-patient mismatch (PPM*) reported in these small annuli patients (aortic annulus area 395.80 + 37.26mm2).Current commercial devices have demonstrated rates between 11.2% to 35.3% PPM1, a predictor of valve failure and disease progression. Anteris Chief Medical Officer, Chris Meduri, M.D., commented: “The one-year data for DurAVR® THV continues to validate its groundbreaking hemodynamic performance, demonstrating sustained excellent effective orifice area (EOA) and low mean gradients. Most notably, this is the only transcatheter valve to show zero prosthesis-patient mismatch (PPM) in small annuli patients—an achievement that sets a new standard in TAVR. PPM is a well-established predictor of valve failure and disease progression, and eliminating it has profound implications for long-term patient outcomes. These results reinforce the transformative potential of DurAVR® as we move toward pivotal trials.” Sixty-five (65) patients have completed the primary endpoint measure at 30 days (previously reported as rolling cohorts at multiple medical conferences through 2023-2024). The DurAVR® THV System continues to demonstrate a consistent safety and efficacy profile, with high implant success across the clinical program. The one-year data builds on the existing body of clinical evidence and will be included in the planned Investigational Device Exemption (IDE) submission to the U.S. FDA to seek approval to conduct the DurAVR® THV randomized, global pivotal study. *Prosthesis‐patient mismatch (PPM) happens when a prosthetic valve, after being implanted, doesn’t have a large enough opening (EOA) to accommodate the patient’s blood flow needs, based on their body size. The result is higher than expected gradients. PPM affects a significant proportion of transcatheter aortic valve (TAVR) patients, particularly patients with a small aortic annulus and has been associated with impaired long-term survival following surgical aortic valve replacement (SAVR)2. 1. Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchétché D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7. PMID: 38587261. 2 Ferrara J, Theron A, Porto A, Morera P, Luporsi P, Jaussaud N, Gariboldi V, Collart F, Cuisset T, Deharo P. Prosthesis-Patient Mismatch in Small Aortic Annuli: Self-Expandable vs. Balloon-Expandable Transcatheter Aortic Valve Replacement. J Clin Med. 2022 Apr 1;11(7):1959. doi: 10.3390/jcm11071959. PMID: 35407567; PMCID: PMC8999619. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including the time for the presentation of the one-year data results and the inclusion of the one-year data in the IDE submission. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. Authorisation and Additional information This announcement was authorised for release on the ASX by the Board of Directors. For more information: Investor Relations Investor Relations (US)investor@anteristech.com mchatterjee@bplifescience.comDebbie Ormsby Malini Chatterjee, Ph.D.Anteris Technologies Global Corp. Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200 +1 917 330 4269 Websitewww.anteristech.comX@AnterisTechFacebookwww.facebook.com/anteristechLinkedInhttps://www.linkedin.com/company/anteristech
