New Evidence Further Defines Distinct Clinical Considerations for Transcatheter Aortic Valve Replacement (TAVR) in Aortic Regurgitation (AR) and Advances Understanding of the Trilogy® System in Patients with Left Ventricular Assist Devices (LVADs)
Coronary/Structural Heart
Amarin Reaffirms the Proven, Guideline-Recommended Role of VASCEPA® (Icosapent Ethyl) in an Evolving Triglyceride Treatment Landscape
Clinically Validated, Increasingly Prescribed, Widely Reimbursed, and Affordable, VASCEPA Expected to Benefit from Increased Attention to Patients with Severely Elevated TriglyceridesDUBLIN, Ireland and BRIDGEWATER, N.J., June 30, 2026 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular disease worldwide, applauds the recent FDA approval of injectable apolipoprotein C-III (APOC3) therapies for the treatment of severe hypertriglyceridemia (sHTG), defined as triglycerides (TG) greater than or equal to 500 mg/dL.i These injectable therapies represent meaningful progress for patients at high risk for serious, sometimes life-threatening diseases associated with sHTG, including acute pancreatitis. “The renewed attention triglycerides generated by the introduction of innovative therapies is welcome, as they help to drive patient–physician conversations and bring critical awareness to the dangers of very high triglyceride levels,” said Aaron Berg, CEO of Amarin. “We recognize the important therapeutic advancement that APOC3 therapies represent and are optimistic about their potential benefit in patients at high risk of acute pancreatitis. For many years, clinicians have managed sHTG with proven, foundational therapies like VASCEPA, which remains a critical, first-line option for millions of individuals who have taken control of their lipid management. We remain mindful that issues such as cost, coverage, and accessibility may influence how and when patients are able to benefit from innovative, yet high-cost therapies. Therefore, we are confident that VASCEPA will continue to deliver strong clinical and economic value for a broad segment of patients with severe hypertriglyceridemia.” Mr. Berg noted the following: Robust Reductions in sHTG Without LDL-C Increases: VASCEPA has been shown to deliver a 33% median reduction in TG levels in patients with sHTG as compared to placebo, with approximately 50% of patients achieving TG levels below 500 mg/dL at 12 weeks.ii,iii These reductions were achieved without the increases in LDL cholesterol observed with certain other triglyceride-lowering agents in patients with sHTG.iv,v,vi Lower Cost, Proven Efficacy, and Broad Access: There is a stark contrast in cost between VASCEPA and recently introduced injectable APOC3 therapies, the most recent of which carries an annual wholesale acquisition cost (WAC) of $40,000 per patient. By comparison, the annual wholesale acquisition cost for VASCEPA is approximately $4,200 per patient. Reflecting this cost differential, many payers, pharmacy benefit managers (PBMs), and managed care organizations may follow a well-established pattern of managing utilization of premium priced therapies through judicious prior authorization and step-therapy requirements.vii Elevated Triglyceride Patients are at Increased Risk for Cardiovascular Disease: VASCEPA has been prescribed more than 30 million times globally for patients with elevated triglycerides and remains the first and only FDA-approved therapy proven to reduce the risk of cardiovascular events by 25% when added to a statin in high-risk patients with elevated triglycerides and other cardiovascular risk factors.viii Global Guideline Support Recently Reaffirmed: 70+ leading medical societies recognize the importance of icosapent ethyl based on the strength of the clinical data. The 2026 American College of Cardiology / American Heart Association / Multisociety Dyslipidemia Guideline reaffirmed the role of established triglyceride-lowering therapies, including VASCEPA, in the management of patients with elevated triglycerides.i Mr. Berg concluded, “We fully appreciate the potential benefits of recently introduced therapies for the segment of sHTG patients who are at high risk of acute pancreatitis. However, for the majority of the sHTG patient population, and for the broader global population of patients with elevated triglycerides at risk for cardiovascular events, significant clinical and economic value will be derived from prioritizing treatments such as VASCEPA that are proven, safe, commonly prescribed, affordable, and widely reimbursed.” About Amarin Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD. About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than thirty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria. United States Indications and Limitation of Use VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s overall efforts to expand access and reimbursement to VASCEPA/VAZKEPA across global markets; expectations regarding potential market dynamics, payer behavior, and the competitive landscape; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025 and subsequent quarterly reports on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin Contact Information Media Inquiries: Tegan Berry Amarin Corporation plc PR@amarincorp.com Investor Inquiries: Devin Sullivan & Conor Rodriguez The Equity Group on Behalf of Amarin devin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.com Investor.relations@amarincorp.com i Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2026 Mar 13:S0735-1097(25)10254-4. doi: 10.1016/j.jacc.2025.11.016. Epub ahead of printii Bays HE, et al. Am J Cardiol. 2011;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015.iii Chowdhury IN. Medical Review(s): Vascepa (Icosapent Ethyl). Silver Spring, MD: US Food and Drug Administration; 2012:50. Application No. 202057Orig1s000. Accessed December 17, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdfiv https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21cfa4ce-0b05-47ed-b268-339eb1b83b75 v https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022224s018lbl.pdf vi Marston NA, Bergmark BA, Alexander VJ, et al.; CORE-TIMI 72a and CORE2-TIMI 72b Investigators. Olezarsen for managing severe hypertriglyceridemia and pancreatitis risk. N Engl J Med. 2025 Nov 8. doi: 10.1056/NEJMoa2512761. vii Annual wholesale acquisition cost: published WAC pricing / data on file. [Medi-Span® Price Rx Pro®”]viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. DOI: 10.1056/NEJMoa1812792
Ventric Health’s Vivio® System Demonstrates High Scalability and Operational Feasibility for Population-Level Heart Failure Screening in New Peer-Reviewed Study
PASADENA, Calif., June 30, 2026 /PRNewswire/ — Ventric Health, a pioneering medical technology company dedicated to enabling the early detection of heart failure (HF) at the point of care, today announced the publication of a new multicenter study in the journal Physiological Measurement….
Laplace Announces FDA IDE Approval of TRIUMPH Pivotal Trial of Its Transcatheter Tricuspid Valve Replacement System
MINNEAPOLIS, June 29, 2026 /PRNewswire/ — Laplace Interventional today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for TRIUMPH, the company’s pivotal trial evaluating its Transcatheter Tricuspid Valve Replacement…
Terumo Interventional Systems Announces First Procedure Using Its OPUSWAVE® Dual Sensor Imaging System in the United States
Marks a major milestone in expanding access to this next-generation intravascular imaging technology, helping physicians make more informed decisions across a wide range of coronary interventions Addresses the need to balance the deep vessel visualization of IVUS with the high-resolution…
Edwards’ Structural Heart Leadership Demonstrated Through Expanding Body of Scientific Evidence at New York Valves
NEW YORK–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced new data presented at New York Valves 2026, the annual conference organized by the Cardiovascular Research Foundation, which reinforce the company’s leadership in advancing high-quality scientific evidence and innovating for patients. These new data – spanning aortic, mitral and tricuspid therapies – provide further understanding of the complexity of structural heart disease and the need for innovative treatment options.
Medera Announces Independent Data Monitoring Committee (DMC) Recommends Continued Advancement of Lead HFpEF Gene Therapy Program
Independent DMC recommends continued conduct of the MUSIC-HFpEF study without protocol modification following scheduled review of accumulated clinical data; randomized HFrEF Phase 2 study also reviewed with no safety concerns requiring changes to study conductBOSTON, June 25, 2026 (GLOBE NEWSWIRE) — Medera Inc. (“Medera”), a clinical-stage biotechnology company developing disease-modifying gene therapies for cardiovascular disease, today announced that the independent Data Monitoring Committee (DMC) has completed its scheduled review of the Company’s ongoing MUSIC-HFpEF clinical trial evaluating SRD-002, Medera’s investigational AAV1/SERCA2a gene therapy for heart failure with preserved ejection fraction (HFpEF). Following review of accumulated clinical data, the independent DMC recommended that the MUSIC-HFpEF study continue without protocol modification. The committee identified no safety concerns requiring changes to study conduct, supporting continued advancement of Medera’s lead clinical program as the Company prepares for discussions with the U.S. Food and Drug Administration (FDA) regarding the next randomized stage of development. The DMC recommendation followed review of accumulated safety and clinical data, including long-term follow-up from both dose cohorts. “We are very encouraged by the outcome of this independent DMC review,” said Ronald Li, PhD, Chief Executive Officer and Founder of Medera. “Independent review by the DMC represents an important milestone for our lead HFpEF program. The review reflected the safety data collected to date and consistency in the physiological and clinical observations across hemodynamic and functional measures. We are particularly encouraged that an independent committee of experienced heart failure specialists and clinical trial experts recommended continued conduct of the study without modification. We believe this outcome further supports the favorable safety profile observed to date and provides additional confidence as we prepare for the next stage of randomized study.” SRD-002 is Medera’s investigational AAV1/SERCA2a gene therapy designed to restore SERCA2a expression and normalize impaired calcium handling within cardiomyocytes, a fundamental biological abnormality underlying HFpEF. Unlike currently approved therapies that primarily improve symptoms or reduce cardiovascular risk, SRD-002 is being developed as a potential disease-modifying therapy targeting the underlying myocardial pathobiology responsible for impaired cardiac relaxation and elevated cardiac filling pressures. The program utilizes Medera’s proprietary targeted intracoronary delivery platform, enabling localized cardiac gene transfer through a minimally invasive catheter-based outpatient procedure while minimizing systemic vector exposure and substantially reducing vector dose requirements compared with conventional systemic intravenous administration. As of the latest DMC review, all ten patients have been successfully treated across two dose cohorts (Cohort A: 3.0 × 10¹³ vg; Cohort B: 4.5 × 10¹³ vg). All patients in Cohort A have completed 12-month follow-up, while patients in Cohort B continue scheduled long-term follow-up. The DMC reviewed comprehensive safety information, including adverse events, laboratory assessments, hepatic function, immune monitoring, and cardiovascular safety data. No gene therapy-related serious adverse events have been reported across the HFpEF clinical program to date. As previously reported at the American Heart Association Scientific Sessions 2025 as a Late-Breaking Clinical Trial Presentation, our Cohort A patients have shown improvements in New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, and hemodynamic parameters, including pulmonary capillary wedge pressure (PCWP), a direct measure of cardiac filling pressure and a central physiological hallmark of HFpEF, at rest and during exercise. The company expects to report 12-month data from Cohort B patients in the last quarter of 2026. “HFpEF remains one of the largest unmet needs in cardiovascular medicine and one of the most challenging diseases to study because of its marked biological and clinical heterogeneity,” added Dr. Li. “We believe objective physiological measurements provide a rigorous framework for assessing therapeutic effects in this setting. This independent DMC recommendation represents an important clinical and regulatory de-risking milestone as we continue preparing for randomized development and future FDA interactions.” The independent DMC also completed its scheduled review of Medera’s MUSIC-HFrEF Phase 1/2a clinical trial data, with no safety concerns identified. The randomized MUSIC-HFrEF Phase 2b trial is currently ongoing. “The independent DMC reviews across both our HFpEF and randomized HFrEF programs provide encouraging support for the safety profile observed to date with our cardiovascular gene therapy platform,” said Roger J. Hajjar, MD, President and Chief Medical Officer of Medera. “We remain focused on completing long-term follow-up, generating robust clinical evidence, and advancing both programs through their next stages of clinical and regulatory development.” Medera expects to provide additional updates regarding its HFpEF and HFrEF clinical programs, including future data presentations, regulatory interactions, and development milestones, as they become available. About Heart Failure with Preserved Ejection Fraction (HFpEF) Heart failure affects more than 64 million people worldwide, with HFpEF accounting for approximately half of all heart failure cases. Patients with HFpEF experience morbidity and mortality comparable to those with heart failure with reduced ejection fraction (HFrEF). Despite its growing prevalence, currently approved therapies primarily improve symptoms and reduce cardiovascular risk rather than directly targeting the underlying myocardial abnormalities responsible for the disease. Consequently, HFpEF remains one of the largest unmet needs in cardiovascular medicine and an area of active therapeutic development. About Medera Inc. Medera is a clinical-stage biotechnology company developing next-generation gene therapies for cardiovascular and other serious diseases. Its pipeline includes multiple AAV-based gene therapy programs targeting heart failure and related cardiovascular disorders. The Company operates through two complementary business units: Novoheart, which provides advanced human-specific cardiac disease modeling and drug discovery platforms, and Sardocor, which leads clinical development of Medera’s gene therapy pipeline. Together, these capabilities create an integrated translational platform spanning discovery, preclinical validation, manufacturing, and clinical development. For more information, please visit www.medera.bio. Forward-Looking Statements This press release contains forward-looking statements regarding Medera’s investigational products, anticipated regulatory interactions, clinical development plans, future clinical data, and potential therapeutic benefits. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Contacts Ally StubinPublic RelationsICR HealthcareAlly.stubin@icrhealthcare.com646.667.1861 Stephanie CarringtonInvestor RelationsICR HealthcareStephanie.carrington@icrhealthcare.com646.277.1282
Atlas Healthcare Physicians to Cover Cardio Diagnostics’ Precision Cardiovascular Medicine Tests Across Its Network
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics today announced that Atlas Healthcare Physicians (AHP) will cover Cardio Diagnostics’ tests, Epi+Gen CHD™ and PrecisionCHD™.
Autonomix Medical Announces Standalone Neural Sensing Program with Evidence of Real-Time Renal Nerve Activity Change
Platform Expected to Target Expansion into Multi-Billion-Dollar Cardiovascular Market with Potential Class II Diagnostic Regulatory Path
Route 92 Medical Announces First Commercial Cases in Canada
Route 92 Medical announces first commercial cases in Canada following Health Canada Medical Device license for advanced neurovascular portfolio.



