Coronary/Structural Heart

FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol

Coronary/Structural Heart by 0 comments

First oral PCSK9 inhibitor provides an additional treatment option for adults with hypercholesterolemiaSilver Spring, MD, July 17, 2026 (GLOBE NEWSWIRE) — The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). PCSK9 inhibitors have previously been available only as injectable therapies. Lipfendra is administered as a once-daily oral tablet and provides an additional treatment option for adults who require further LDL-C reduction despite existing therapies. The approval also reflects continued advances in the development of therapies for chronic cardiovascular disease management. “Cardiovascular disease remains the leading cause of death in the United States, and elevated LDL cholesterol is one of its most important modifiable risk factors,” said Michael Davis, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research. “This approval provides an additional treatment option for adults with hypercholesterolemia and reflects the FDA’s broader commitment to supporting meaningful advances in patient access and tackling chronic diseases.” Hypercholesterolemia occurs when there is too much LDL-C in the blood. Over time, excess LDL-C can accumulate within the walls of arteries, contributing to the formation of plaques that narrow blood vessels and restrict blood flow. If a plaque ruptures, it can trigger the formation of a blood clot, increasing the risk of heart attack or stroke. Because high cholesterol typically causes no symptoms, many people are unaware they have the condition until it is detected through routine blood testing. Diet, physical inactivity, excess body weight, and inherited genetic conditions can all contribute to elevated cholesterol levels. Several classes of medications are available to lower LDL-C, including statins, ezetimibe, and injectable PCSK9 inhibitors. Lipfendra is the first oral therapy to inhibit PCSK9. The efficacy and safety of Lipfendra were evaluated in two randomized, double-blind, placebo-controlled clinical trials involving 3,207 adults with hypercholesterolemia, including patients with and without HeFH, who were receiving maximally tolerated statin therapy. The primary endpoint in both studies was the percent change in LDL-C from baseline to Week 24 compared with placebo. In the first trial, which enrolled adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for ASCVD, participants had a mean baseline LDL-C of 96 mg/dL. Treatment with Lipfendra resulted in an average 56% reduction in LDL-C at Week 24 compared with placebo. In the second trial, which enrolled adults with HeFH, participants had a mean baseline LDL-C of 119 mg/dL. Treatment with Lipfendra resulted in an average 59% reduction in LDL-C at Week 24 compared with placebo. In the first trial, the frequency of adverse reactions was similar between patients treated with Lipfendra and those receiving placebo. In the second trial, the most common adverse reactions occurring more frequently with Lipfendra than placebo were diarrhea and dizziness. Across both trials, discontinuation rates due to adverse reactions were comparable between the Lipfendra-treated and placebo-recipient groups. Lipfendra received Priority Review for this indication. The application was also reviewed under the Commissioner’s National Priority Voucher (CNPV) pilot program, which is intended to help accelerate the review of therapies that address national public health priorities. The approval was granted to Merck Sharp & Dohme LLC. ### The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. Contact Info U.S. Food and Drug AdministrationFDAPressAlerts@fda.hhs.gov+1 202-690-6343

Continue Reading →

A breakthrough in coronary bypass surgery: AMT Medical’s SAFE-CAB results published in The Journal of Thoracic and Cardiovascular Surgery

Coronary/Structural Heart by 0 comments

Video: How does AMT’S ELANA® system work?   The first suture-less, beating-heart bypass connection, shown to be safe with promising early effectiveness in a peer-reviewed clinical trial. AMT Medical reports one-year results from the SAFE-CAB II prospective clinical trial in The Journal of Thoracic and Cardiovascular Surgery1 (link). Its results provide important first-in-human clinical experience with a technology designed to support a new generation of bypass surgery that could enable more standardized procedures and broader adoption of minimally invasive and robotic approaches. At a glance A first-of-its-kind clinical trial: the ELANA® system replaces hand-sewing of the bypass connection with a sutureless, laser-assisted technique that keeps the coronary artery open throughout surgery.Strong safety profile: Only 2.9% of patients experienced a device-related major adverse cardiac event (MACE) within one year, meeting the pre-specified non-inferiority threshold (p = 0.0033).Strong effectiveness: 92.5% of bypass connections remained fully open at six months across the full study, rising to 97.5% with the latest-generation laser catheter, in line with the performance gains anticipated from this device iteration.Reproducible by design: a defined six-step procedure, described in detail in a companion technical publication in the Journal of Visualized Surgery (JOVS, 2026). Published in The Journal of Thoracic and Cardiovascular Surgery (JTCVS), the flagship journal of the American Association for Thoracic Surgery. EDE / UTRECHT, The Netherlands, 16 July 2026 — AMT Medical B.V., a clinical-stage Dutch medical technology company, today announced that the one-year results of the SAFE-CAB II clinical trial have been published in The Journal of Thoracic and Cardiovascular Surgery. The study is the first prospective clinical evaluation of the ELANA® Anastomotic System, a new technology designed to make coronary artery bypass grafting (CABG) more reproducible and accessible to a far broader group of patients. Why this matters, for patients and for healthcare systems Coronary artery bypass grafting is the most durable treatment for advanced coronary artery disease, with around one million procedures performed worldwide every year. Despite decades of innovation, the most critical step of the operation, sewing the bypass graft onto the diseased coronary artery by hand, has remained essentially unchanged since the 1960s. It is delicate, time-consuming, and the single technical step most often cited by surgeons as the obstacle to wider use of minimally invasive and robotic bypass techniques. The ELANA® Anastomotic System replaces that hand-sewn connection with a small titanium clip and a precisely controlled laser pulse. The connection is made before the artery is opened, so the coronary artery never has to be clamped or temporarily blocked, blood keeps flowing throughout the procedure. For patients.  A sutureless, flow-preserving connection is a foundational enabler of minimally invasive and robotic CABG, approaches associated in the published literature with smaller incisions, less surgical trauma, shorter hospital stays, faster return to daily life and a reduced risk of complications compared with traditional open-chest surgery. SAFE-CAB II now provides the first prospective clinical evidence that this enabling technology is safe and effective in human use. For surgeons and hospitals.  A defined, six-step mechanical procedure replaces a hand-sewn step requiring 8–12 hand-sewn stitches per anastomosis, that today is highly skill-dependent. By removing the human-factor variability inherent to hand-sewing, the procedure is designed to reduce variation regardless of which surgeon performs it. For healthcare systems.  The shorter recovery, fewer complications and shorter ICU and hospital stays associated with minimally invasive bypass approaches create the potential for meaningful improvements in capacity utilization and cost efficiency, where freed-up capacity can be put to use. An internal health-economic assessment, based on benchmark data from major CABG literature, estimates that, at scale, direct CABG-related hospital costs could be reduced by 35-50% relative to conventional open-chest CABG, with additional productivity gains for working-age patients through faster return to work. “For the first time, a rigorous prospective trial shows that the most challenging step of a bypass operation can be performed without sutures on a beating heart, and without ever interrupting blood flow to the patient’s coronary artery. That is genuinely new. It is the technical breakthrough the field has been waiting for to make modern, less invasive bypass surgery available to many more patients than today.” — Bart P. van Putte, MD PhD, Principal Investigator; Department of Cardiothoracic Surgery, St Antonius Hospital, Nieuwegein, and Amsterdam UMC The SAFE-CAB II trial in brief SAFE-CAB II (registered as DRKS00020545 and NCT07005843) is a prospective, single-arm clinical trial conducted at St Antonius Hospital in Nieuwegein, The Netherlands, in close collaboration with Deutsches Herzzentrum der Charité in Berlin, Germany. Between June 2023 and September 2024, 71 patients undergoing elective CABG received the bypass connection between the left internal thoracic artery and the left anterior descending coronary artery, the most clinically important bypass in the operation, using the ELANA® system. Patients had an average age of 71 years; the average number of bypass connections per patient was 3.5. All angiographic data were independently reviewed by Cardialysis (Rotterdam, The Netherlands), one of the leading academic core laboratories in cardiovascular research. The trial was monitored end-to-end by an independent contract research organization (HEMEX AG) under the continuous oversight of an independent Data Safety Monitoring Board, and conducted in compliance with the Declaration of Helsinki, the EU Medical Devices Regulation, and ISO 14155 and 14971 standards. What the data show Primary endpoint met: device-related serious cardiac events at one year occurred in 2.9% of patients, statistically non-inferior to the historical surgical benchmark (p = 0.0033).Six-month patency: 92.5% across the full trial, and 97.5% in the subgroup treated with the latest-generation laser catheter. These rates match the upper range of what is reported for the best hand-sewn bypasses.In a subset of patients with an angiographically uncertain result, intravascular ultrasound confirmed the bypass connection was fully open and unobstructed.Total one-year serious cardiac events was 8.7%, as expected.No safety concerns related to the device were identified by the independent Data Safety Monitoring Board. How the ELANA® Anastomotic System works The ELANA® technology was originally developed at UMC Utrecht in the Netherlands for bypass surgery in the brain, received CE marking in 2008 and FDA clearance in 2012 for that indication, and has since been used in more than 1,000 patients worldwide. Over the past decade, AMT Medical’s team has re-engineered the platform specifically for the coronary anatomy, with extensive preclinical validation including ex-vivo human hearts and large-animal studies. In the operating room, the surgeon uses the ELANA® system to attach a small titanium clip to the coronary artery and then fires a controlled laser pulse that creates a clean opening within the clip. The connection is made in a fully defined six-step sequence rather than relying on hand-sewn stitches one at a time. Because the connection is made before the artery is opened, blood continues to flow to the heart muscle throughout the procedure. The six-step procedure is described in detail in a separate peer-reviewed technical publication in the Journal of Visualized Surgery (JOVS, 2026)2. Market opportunity and next steps Coronary artery disease is the leading cause of death globally, and CABG remains the most durable treatment for its most advanced forms. The global CABG device market represents a substantial and recurring annual opportunity, and is expected to expand further as the percentage of procedures performed using minimally invasive and robotic approaches grows. Today, the lack of a reliable sutureless connection technology is widely viewed as the single most important barrier holding that transition back. With SAFE-CAB II peer-reviewed and published, AMT Medical now has the clinical foundation to move into the next phase of its commercial and regulatory pathway: Preparing CE marking for open and MIDCAB (minimally invasive direct coronary artery bypass) indications under the EU Medical Devices Regulation.Preparing an Investigational Device Exemption submission with the U.S. Food and Drug Administration for an Early Feasibility Study, in collaboration with leading U.S. cardiac surgery centers with discussions currently underway with several leading academic centers.Initiating the next generation of clinical trials in minimally invasive and robotic settings, including a planned multivessel investigation.Continuing the two-year follow-up of the SAFE-CAB II cohort. Earlier this year, AMT Medical appointed Geert van Gansewinkel as Chief Executive Officer to lead the company through this next growth phase. Mr. van Gansewinkel joined AMT Medical from GATT Technologies, where as CEO he led the company through CE marking in 2023, FDA PMA approval in 2025, and a successful acquisition by Johnson & Johnson in 2025. Founder Rutger Tulleken transitioned to the role of Founder and Strategic Advisor, where he continues to support platform innovation, intellectual property development, grant funding and collaboration with surgeons and research institutions. AMT Medical has raised over EUR 40 million to date, including a USD 25 million Series B in 2025 led by Bender Analytical Holding B.V., with participation from Invest-NL, the European Innovation Council Fund and Oost NL. “Peer-reviewed publication in JTCVS is a defining milestone for AMT Medical. It places the ELANA platform on a solid clinical foundation, independently adjudicated and reviewed by the international cardiothoracic surgery community. We now have everything we need to take the next steps: CE marking for open and MIDCAB indications, an IDE submission with the FDA in collaboration with leading U.S. centers, and the next generation of trials in minimally invasive and robotic surgery. Our goal is simple, to make high-quality bypass surgery, with faster recovery and fewer complications, available to far more patients than today.” — Geert van Gansewinkel, Chief Executive Officer, AMT Medical B.V. About AMT Medical B.V. AMT Medical B.V. is a Dutch medical technology company developing the ELANA® Anastomotic System for coronary artery bypass surgery. Founded on technology pioneered at UMC Utrecht for neurovascular bypass surgery and brought to market under CE and FDA approvals by the original ELANA team, AMT Medical is headquartered in Ede with laboratory facilities in Utrecht, The Netherlands. The company is ISO 13485-certified and holds more than 40 patents. AMT Medical collaborates with leading cardiac surgery centers in The Netherlands, with Charité – Universitätsmedizin Berlin in Germany and is building relationships with leading academic centers in the United States, supported by an international network of cardiothoracic surgery and cardiology key opinion leaders. DISCLAIMERThe ELANA® Anastomotic System for coronary artery bypass is an investigational device. It has not yet received CE marking and is not cleared or approved by the U.S. FDA for commercial sale. For more information, visit www.amt-medical.nl or find us on LinkedIn. REFERENCES 1. Beukers SHQ, Jacobs S, Klein P, Bronkers G, Moormans LR, Ten Berg J, Falk V, van Putte BP. The first prospective Safety And eFfectiveness trial of the ELANA heart bypass system in Coronary Artery Bypass grafting (SAFE-CAB II trial). The Journal of Thoracic and Cardiovascular Surgery. 2026.  LINK 2. Beukers SHQ, et al. The ELANA Heart Bypass System: a sutureless, laser-assisted technique for coronary artery bypass anastomosis. Journal of Visualized Surgery (JOVS). 2026, LINK MEDIA AND INVESTOR CONTACTS AMT Medical B.V.   —   Ede / Utrecht, The NetherlandsGeert van Gansewinkel, Chief Executive Officerinfo@amt-medical.nl   •   +31 85 105 7070 LifeSpring Life Sciences Communication   —   AmsterdamLeon Melenslmelens@lifespring.bio   •   +31 6 538 16 427 ELANA® is a registered trademark of AMT Medical B.V. —  END —
Attachments

The Journal of Thoracic and Cardiovascular Surgery – ELANA anastomotic system

AMT_Medical_SAFE-CAB_JTCVS_Press_Release

Continue Reading →

CryoTherapeutics Announces First Patient Treated in ICECAP Clinical Trial Evaluating Localized Cryotherapy for Coronary Artery Disease

Coronary/Structural Heart Regulatory by 0 comments

LIÈGE, Belgium–(BUSINESS WIRE)–CryoTherapeutics, a medical device company developing minimally invasive localized cryotherapy for the treatment of coronary artery disease, today announced the successful treatment of the first patient in its ICECAP clinical trial. The milestone marks an important step in evaluating whether localized cryotherapy can help stabilize vulnerable coronary plaques before they lead to myocardial infarction. During ICECAP screening, the first patient with stable angina

Continue Reading →

Artificial Organs Publishes Independent Commentary on Picard Medical and SynCardia’s Emperor Total Artificial Heart Program

Coronary/Structural Heart by 0 comments

Peer-reviewed journal’s News section highlights the Company’s continued progress toward a fully implantable total artificial heartTUCSON, Ariz., July 15, 2026 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard Medical” or the “Company”), parent company of SynCardia Systems, LLC (“SynCardia”), maker of the world’s first and only total artificial heart approved by the U.S. Food and Drug Administration (“FDA”) and Health Canada, today announced the publication of an independent commentary in Artificial Organs examining the Company’s next-generation Emperor platform, which combines the Emperor Drive with the SynCardia Total Artificial Heart (“STAH”), and its role in the continued evolution of mechanical heart replacement technology. The article, titled “A New Chapter in the Quest for a Fully Implantable Artificial Heart”, was authored by Aakash M. Shah, M.D., an integrated cardiothoracic surgery resident at University of Texas Health Science Center at San Antonio (UT Health San Antonio) and lead editor of the News section of Artificial Organs. The commentary reviews the history of total artificial heart development and highlights the Company’s recent preclinical studies of what the publication refers to as the “Emperor TAH” as another milestone in the pursuit of a fully implantable artificial heart. The commentary discusses the latest series of acute large-animal implant studies evaluating the Company’s next-generation Emperor platform. As previously announced by the Company, three implant procedures were completed successfully, with the device providing stable full circulatory support, demonstrating physiologic autoregulatory behavior, and experiencing no device-related intraoperative failures. The article also highlights the Emperor platform’s independent dual-motor architecture, which enables independent control of the systemic and pulmonary circulations. The article explains how the design achieves a higher fidelity to closely replicate physiologic cardiac function while eliminating the need for an external pneumatic driver. “The independent commentary published in Artificial Organs places the Emperor platform within the broader context of the decades-long effort to develop a practical, fully implantable artificial heart,” said Richard Fang, Ph.D., Interim Chief Executive Officer and Chairman of Picard Medical. “While significant work remains, we believe the successful acute implant studies represent an encouraging preclinical milestone. We remain focused on the engineering, preclinical, and regulatory work necessary to advance the Emperor platform toward human clinical evaluation.” The commentary also reviews SynCardia’s more than two decades of clinical experience in total artificial heart therapy, noting that the SynCardia Total Artificial Heart remains the only commercially available total artificial heart approved in both the United States and Canada. Within the Company’s development program, this next-generation platform consists of the Emperor Drive, a electromechanical drive system under development, integrated with the STAH. Together, the platform is designed to provide independent control of the systemic and pulmonary circulations while building upon the proven pumping principles established through the SynCardia Total Artificial Heart. The article concludes that continued advances in total artificial heart technology have the potential to expand future treatment options for patients with advanced biventricular heart failure who may not receive a donor heart, due to health conditions rendering the patient ineligible or a lack of supply. As stated by the publication, the article is intended as a news update for the journal’s readership and does not constitute an endorsement of the Company. Article Reference Shah AM. A New Chapter in the Quest for a Fully Implantable Artificial Heart. Artificial Organs. 2026. doi:10.1111/aor.70182. Read the article: https://onlinelibrary.wiley.com/doi/10.1111/aor.70182 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 STAH 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 (the “SEC”) at www.sec.gov. Forward-looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on management’s current expectations, assumptions, and beliefs and involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Forward-looking statements can often be identified by words such as “anticipate,” “believe,” “continue,” “expect,” “goal,” “intend,” “may,” “plan,” “remain,” “target,” “will,” “advance,” “expand,” and similar expressions, and variations or negatives of these words. These statements include, but are not limited to, statements regarding the Company’s financial condition, future operating results, commercialization activities, expectations for growth, expanding utilization of the SynCardia Total Artificial Heart, expanding patient access at transplant centers, supporting clinical partners, advancing development of the Emperor Total Artificial Heart and other next-generation technologies, regulatory submissions and approvals, manufacturing and supply chain initiatives, capital raising activities, strengthening the Company’s commercial and financial position, strategic initiatives, leadership transitions, and other statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Factors that may cause such differences include, but are not limited to, risks relating to the Company’s ability to obtain additional financing, maintain compliance with applicable stock exchange listing requirements, achieve commercial adoption of its products, obtain regulatory approvals, execute manufacturing and supply chain initiatives, successfully develop next-generation technologies, manage market conditions, and other risks described in the Company’s filings with the U.S. Securities and Exchange Commission (”SEC”). The Company expressly disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances, or otherwise, except as required by law. Additional information about the Company, including risk factors that may affect the Company’s business, financial condition, and results of operations, is contained in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available free of charge at www.sec.gov and on the Company’s investor relations website at www.picardmedical.com. Contact: InvestorsEric RibnerManaging DirectorLifeSci Advisors LLCeric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLCIR@picardmedical.com General/MediaBrittany Lanzablanza@syncardia.com

Continue Reading →

HitGen Partner BioAge Labs Doses First Participant in Phase 2 Trial of BGE-102, a Novel Oral NLRP3 Inhibitor for Cardiovascular Risk Reduction

Coronary/Structural Heart by 0 comments

CHENGDU, China, July 14, 2026 /PRNewswire/ — Shanghai Stock Exchange listed company HitGen Inc. (“HitGen”, SSE: 688222.SH), congratulates its partner BioAge Labs, Inc. (“BioAge”, NASDAQ: BIOA), a clinical-stage biopharmaceutical company developing therapeutic product candidates for…

Continue Reading →

New Clinical Study Data, Featuring Nanox.AI Cardiac Solution to Be Presented at SCCT 2026

Coronary/Structural Heart by 0 comments

 AI solution, showing high agreement with expert assessment and its potential role in supporting guideline-directed preventive care. From incidental finding to clinical action: the AI INFORM randomized trial highlights how AI-detected coronary calcium may help clinicians identify opportunities for preventive lipid-lowering therapy. Nanox.AI Sponsors SCCT Scientific Session, “From Missed Finding to Missed […]

Continue Reading →

New Data at SCCT 2026 Reinforce Heartflow Plaque Analysis as the Standard for AI-Powered Coronary Artery Disease Management

Coronary/Structural Heart by 0 comments

Risk Stratification Based on TPV, an Independent Predictor of Events

Predict risk where stenosis and traditional risk factors don’t.

Heartflow Plaque StagingTM, the only staging tool based on total plaque volume*, is now included with every Heartflow Plaque Analysis Data from over 36,000 patients validate the accuracy, reproducibility and utility of Heartflow Plaque Analysis SAN FRANCISCO, July 09, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced eight new datasets from clinical studies spanning more than 36,000 patients will be presented at the Society of Cardiovascular Computed Tomography (SCCT) 2026 Annual Scientific Meeting taking place July 9-12, 2026 in San Diego. These studies reveal over 50% of symptomatic patients with zero coronary artery calcium (CAC) harbor significant non-calcified plaque that traditional CAC scoring cannot detect. This underscores a serious diagnostic gap in accurately risk stratifying patients to impact their clinical outcomes. Heartflow Plaque Analysis with Heartflow Plaque Staging closes this gap. The new data show Heartflow’s technology comprehensively reclassifies risk, is highly reproducible, and remains consistent across scanner types— making Heartflow the trusted standard in AI-powered coronary plaque analysis. Building on this evidence, Heartflow announced the launch of Heartflow Plaque Staging, the only CAD staging tool based on total plaque volume (TPV), integrated into every Heartflow Plaque Analysis. Heartflow Plaque Staging is backed by the strongest data with up to 16 years of follow-up and prospectively demonstrated clinical utility.1,2,3 Every case now includes a Heartflow Plaque Stage—from mild to extensive—based on TPV. Plaque Stages generate automatically in the Heartflow One platform’s User Interface and Structured Report, enabling seamless integration into existing clinician workflows. This allows clinicians to precisely risk stratify patients and confidently manage their care without delay. “These data underscore why Heartflow Plaque Analysis is the standard for reliable AI-powered coronary plaque analysis,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “Clinicians need confidence that a plaque measurement shift reflects true disease progression, not analytical variation. Our studies show total plaque volume-based staging is both reproducible and consistent across scanner types, giving physicians the insights they need for longitudinal disease tracking and evidence-based treatment decisions.” Key presentations include: DECIDE Registry (Poster 604): Heartflow Plaque Staging Reclassifies Risk Missed by Traditional Calcium ScoringSaturday, July 11, 10:55-11:40 a.m. Symptomatic patients with zero CAC scores can remain at substantial risk from non-calcified (soft) plaque that calcium scoring cannot detect. This DECIDE Registry sub-study of 11,792 symptomatic patients quantifies this diagnostic challenge and demonstrates how TPV-based Heartflow Plaque Staging delivers a precise solution. Half of all patients presenting with a CAC score of zero, traditionally considered “zero risk,” were reclassified into higher-risk categories once TPV was considered, confirming the presence of non-calcified plaque missed by calcium scoring alone.30% of patients with CAC scores of 1-99 or 100-299 were moved to a higher-risk category with the addition of TPV, indicating more significant plaque burden.The study also demonstrated downward classification in patients with high calcium but more modest TPV, including downward classification in 27% of patients with CAC scores of 1,000 or higher. Results showed that male patients exhibited more upward reclassification, and female patients exhibited more downward reclassification, across all CAC scores. These data reinforce previously published findings that Heartflow Plaque Staging changed management in more than 50% of patients.4 This latest analysis provides a model for intensifying preventive therapy in patients with high TPV despite zero calcium and for de-escalating in patients with high calcium but lower TPV, demonstrating the value of characterizing both calcified and non-calcified disease burden. “While coronary calcium scoring has been a helpful foundational tool, relying on calcium scoring alone leaves a diagnostic gap for clinicians, particularly regarding high-risk non-calcified plaque,” said study investigator Vincent L. Sorrell, M.D., the immediate past Chief of the Division of Cardiovascular Medicine and Co-Director of Cardiovascular Research Priority Area at the Gill Heart & Vascular Institute at University of Kentucky HealthCare. “The DECIDE data demonstrate that Heartflow’s TPV-based staging unmasks important cardiovascular disease in over half of symptomatic patients who present with a calcium score of zero. This enhances our ability to accurately identify at-risk individuals and optimize preventive management based on a more precise understanding of their actual disease burden.” High Precision & Reproducibility (Poster 633): Validating Heartflow Plaque Analysis for Longitudinal Disease TrackingSaturday, July 11, 10:55-11:40 a.m. Serial monitoring of CAD only works if measurement variability can be distinguished from true disease change. This study shows Heartflow Plaque Analysis meets this requirement, with minimal inter- and intra-observer variability in a blinded, prospective study—delivering the reproducibility clinicians need for longitudinal tracking with confidence. The study analyzed 27 coronary computed tomography angiography (CTA) scans, which were blinded and evaluated three times each by three certified analysts, providing 243 independent analyses in total. The study demonstrated minimal relative variability between different qualified analysts, with coefficients of variation of 3% for TPV, 6% for calcified plaque, and 4% for non-calcified plaque.Repeat analyses by the same qualified analyst proved highly consistent, with variation rates of 5% for TPV, 6% for calcified plaque, and 6% for non-calcified plaque.The Fleiss’ kappa score for categorizing patients into TPV-based plaque stages was 95%. This level of agreement establishes the technology as highly reliable for clinical-trial-grade serial monitoring and future tracking of disease progression over time. Real-World Scanner Transition (Poster 618): Analytical Consistency Across Conventional and Photon-Counting CTSaturday, July 11, 10:55-11:40 a.m. As healthcare facilities transition from conventional Energy-Integrating Detector (EID) CT systems to next-generation Photon-Counting CT (PCCT), maintaining analytical consistency is critical for clinical continuity. This retrospective, multi-center study of 12,269 patients across eight clinical sites directly tested whether Heartflow’s plaque quantification, stenosis grading, and FFRCT values remain consistent across this scanner technology transition. Results showed no significant differences between EID and PCCT for TPV, non-calcified plaque, calcified plaque, maximum stenosis grade, lowest FFRCT value and anatomy-physiology reclassification rates. The findings demonstrate that clinical sites transitioning to next-generation PCCT can ensure comparisons using Heartflow Plaque Analysis remain valid during scanner transitions. Together, these findings show why Heartflow Plaque Analysis is setting the standard in AI-powered CAD management: delivering Plaque Staging that comprehensively reclassifies risk, reproducible results over time, and consistency that holds across scanners. Experience Heartflow Plaque Staging at SCCT 2026SCCT 2026 attendees are invited to visit the Heartflow exhibit booth (Booth #101) for live demonstrations of Heartflow Plaque Staging. Attendees can observe firsthand how the workflow translates complex plaque data into actionable insights. See the full schedule of other Heartflow programs, including a lunch symposium, product showcase theater, educational reception, and more at event.heartflow.com/scct. About Heartflow Plaque Analysis with Plaque StagingHeartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque analysis tool with a reported 95% agreement with the gold standard, intravascular ultrasound (IVUS), in a prospective, international trial using blinded core lab adjudication.5 Heartflow Plaque Staging builds on this foundation, categorizing plaque burden into clinical risk stages based on total plaque volume, enabling clinicians to move from measurement to actionable risk stratification.6,7 The staging framework has been prospectively validated in 23,000 patients with up to 16 years of follow-up, leveraging a highly reproducible analysis suitable for serial disease monitoring and guiding individualized preventive treatment strategies. About Heartflow’s Technology and Research Heartflow’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 1,800 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 American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 650,000 patients worldwide.8 Key benefits include: Unmatched Proprietary data pipeline: Built from the world’s largest database of more than 200 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 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.9,10,11,12 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.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, 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 Contact Elliot Levy elevy@heartflow.com Investor Contact Nick Laudico nlaudico@heartflow.com 1 Fairbairn, et al. Presented at AHA Scientific Sessions November 2025.2 Huck, et al. Presented at ACC 2026.3 Chandrashekhar et al. 2025. Quantitative Coronary Plaque Analysis in Clinical Practice. 202 ACC Scientific Statement. doi/10.1016/j.jcmg.2025.11.0084 Rinehart SJ, et al. DECIDE Primary Outcomes. J Cardiovasc Comput Tomogr. 2025; 19(4):S78-79. doi.org/10.1016/j.jcct.2025.05.1855 Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.6 Rinehart, et al. JACC Imaging. 2025.7 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)8 Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol9 Narula, et al. E HJ CVI 202410   Danad, et al. JAMA Cardiol 201711 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)12 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024 (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years)* As of July 2026, Heartflow Plaque Staging is the only tool integrated within a commercially available product. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b543e9a9-f827-4ac4-949b-13c5c610fb72.

Continue Reading →

VisCardia Implants First U.S. Patient in RECOVER-HF Pivotal Trial

Coronary/Structural Heart Regulatory by 0 comments

Milestone in pivotal IDE evaluation of VisONE™ Synchronized Diaphragmatic Stimulation Therapy for symptomatic heart failure with reduced ejection fraction; FDA Breakthrough Device Designation Milestone in pivotal IDE evaluation of VisONE™ Synchronized Diaphragmatic Stimulation Therapy for symptomatic heart failure with reduced ejection fraction; FDA Breakthrough Device Designation

Continue Reading →
1 2 3 … 439