Coronary/Structural Heart

Edwards Lifesciences Advances Structural Heart Care Through Innovation and Purpose

IRVINE, Calif.–(BUSINESS WIRE)–At the close of Heart Month, Edwards Lifesciences (NYSE: EW) underscored its leadership in structural heart innovation, advancing care through deep expertise and strong partnerships so people with structural heart disease can live longer, healthier lives. As part of this commitment, Edwards announced the impact and renewed vision for Every Heartbeat Matters, its signature global health initiative, to help 2 million more patients facing barriers worldwide access

Medtronic Receives Reimbursement Approval for Symplicity Spyral™ Renal Denervation System in Japan

Milestone expands patient access to the first and most studied renal denervation therapy for hypertension. DUBLIN – February 19, 2026 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted reimbursement approval for the Symplicity Spyral™ renal […]

Cardiac Surgeons at Allegheny General Hospital First in Region to Successfully Perform Transcatheter Tricuspid Valve Replacement Procedure

PITTSBURGH, Feb. 20, 2026 /PRNewswire/ — Cardiac experts from Pittsburgh’s Allegheny Health Network’s (AHN) Allegheny General Hospital (AGH) announced today they are the first in the region and among the first in the state to successfully perform a transcatheter tricuspid valve…

Omada Adds Cholesterol Care to Its Integrated Platform, Addressing the Silent Driver of Cardiovascular Risk

Omada for Cholesterol closes a critical gap in cardiovascular care, delivering between-visit support for the many adults whose LDL remains uncontrolled under usual care¹SAN FRANCISCO, Feb. 19, 2026 (GLOBE NEWSWIRE) — Omada Health (Nasdaq: OMDA), the virtual-first, between-visit healthcare provider, today announced the expansion of its integrated platform to include dedicated cholesterol management alongside weight, glucose, blood pressure, and GLP-1 support. Up to 70% of adults with obesity have high cholesterol,1 yet among U.S. adults with atherosclerotic cardiovascular disease, only 41% ever reached a healthy LDL-C level (

Elsevier expands ClinicalKey AI with unrivaled full-text knowledge base and technology upgrades to help clinicians make decisions with confidence

ClinicalKey AI now includes full-text content from premium journals and medical organizations such as The Lancet, the New England Journal of Medicine (NEJM), the European Society For Medical Oncology and the American College of Cardiology, offering the broadest collection of trusted…

Retia Medical Receives FDA 510(k) Clearance for Argos Infinity™, Expanding Cardiovascular Intelligence Across High-Risk Surgical and Critical Care Environments

WHITE PLAINS, N.Y., Feb. 17, 2026 /PRNewswire/ — Retia Medical today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Argos Infinity™, the company’s cardiovascular intelligence software platform designed for high-risk surgical and critical care…

Cytokinetics Announces European Commission Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

European Commission Approval Based on Results of SEQUOIA-HCM First European Launch Expected in Germany in Q2 2026 SOUTH SAN FRANCISCO, Calif., Feb. 17, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Commission (EC) has approved MYQORZO® (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. “The approval of MYQORZO in the European Union is an important milestone towards bringing this medicine to more patients living with obstructive HCM around the world,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are pleased that the European label allows providers flexibility to determine whether a patient starts treatment at either 5 mg or 10 mg, based on the severity of their baseline LVOT obstruction. We look forward to making MYQORZO available in Europe, beginning with our first launch in Germany in the second quarter of this year.” “Myosin inhibition is establishing itself as an important therapy that may improve the lives of patients with hypertrophic obstructive cardiomyopathy. The approval of aficamten by the European Commission brings another treatment option into our clinical practice, allowing for more treatment flexibility to reach more patients,” said Prof. Benjamin Meder, FESC, Chair of Precision Digital Health, Head of the Institute for Cardiomyopathies Heidelberg and Deputy Medical Director, Department of Cardiology, Angiology and Pneumology, University Hospital Heidelberg.  “Obstructive HCM can dramatically impact patients’ lives and often requires them to make difficult life choices based on their symptoms and how they feel,” said Emil Tsenov, Founding and Managing Director, HCM Patient Foundation. “The approval of MYQORZO in the European Union brings hope for patients and reflects meaningful progress for the HCM community.” The EC approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorization in the European Union (EU) for MYQORZO for the treatment of symptomatic (NYHA class II-III) oHCM in adult patients.  MYQORZO was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms, and by the China National Medical Products Administration (NMPA) for the treatment of adults with NYHA class II-III oHCM, to improve exercise capacity and symptoms. The Summary of Product Characteristics for MYQORZO is available on the EMA website at www.ema.europa.eu. About SEQUOIA-HCM The EC approval is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints. The results from SEQUOIA-HCM showed that treatment with MYQORZO for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.76 mL/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 mL/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 – 2.44]; p=0.000002).1 The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy. During the 24-week treatment period, 3.5% of patients in the treatment group experienced a reversible dose related reduction in left ventricular ejection fraction (LVEF) to

Medtronic reports strong third quarter fiscal 2026 results with highest enterprise revenue growth in 10 quarters

Cardiovascular portfolio up 11% year-over-year; Cardiac Ablation Solutions grew 80% on strength of pulsed field ablation portfolio GALWAY, Ireland, Feb. 17, 2026 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced financial results for its…

AMT Medical Appoints Geert van Gansewinkel as CEO to Lead Company into Next Growth Phase Revolutionizing Coronary Artery Bypass Surgery

Geert van Gansewinkel appointed as new CEO of AMT Medical

AMT Medical is a pioneering medical technology company developing a next-generation minimally invasive coronary bypass platform. Its ELANA® Heart Bypass System delivers a minimally invasive solution designed to replace traditional open-heart bypass surgery, ultimately leading to robot-assisted keyhole surgery compatible with surgical robots from industry leaders.

www.amt-medical.nlhttps://vimeo.com/636954313 Anticipated Clinical Results on Graft Durability and Minimally Invasive Applications to Shape Company’s Future EDE/UTRECHT, The Netherlands – February 17, 2026 – AMT Medical, a pioneering medical technology company developing a next-generation minimally invasive coronary bypass platform, today announced the appointment of Geert van Gansewinkel as Chief Executive Officer, effective immediately. The leadership transition positions the company for its next phase of development of its ELANA® Heart Bypass System, as AMT anticipates sharing significant clinical program updates in the near term that are expected to define its regulatory pathway and commercial trajectory. ELANA® delivers a minimally invasive solution designed to replace traditional open-heart bypass surgery, ultimately leading to robot-assisted keyhole surgery compatible with surgical robots from industry leaders. Founder and former CEO Rutger Tulleken will transition to the role of Founder & Strategic Advisor, where he will continue to support platform innovation, intellectual property development, grant funding initiatives, and collaboration with surgeons and research institutions, while ensuring a smooth leadership transition. Strategic timingThe appointment reflects strategic timing as the company approaches key inflection points. AMT expects to provide important updates on its clinical programs, including patency performance data (data showing the bypasses remain open) and progress in minimally invasive MIDCAB (keyhole bypass surgery) applications, that will inform the company’s transition from technology validation to structured regulatory advancement, clinical expansion, and operational scale-up. These anticipated milestones underscore the strategic rationale for bringing in experienced leadership at this juncture. Geert van Gansewinkel most recently served as Chief Executive Officer of GATT Technologies BV, a Dutch medical technology company focused on developing innovative polymer-based surgical sealant and adhesive solutions for tissue repair and hemostasis. He led the company through the complete development pathway, including preclinical validation, multiple clinical trials in Europe and the United States, and full regulatory approval processes. Under his leadership, GATT obtained CE marking in 2023 and FDA PMA approval in 2025, culminating in a successful acquisition by Johnson & Johnson in 2025. He managed the strategic transaction and subsequent integration into the acquiring organization. Earlier in his career, Geert held senior leadership roles at IQVIA and Polaris, where he co-led the exit to IQVIA. He also worked at The Boston Consulting Group, leading strategy, transformation, and post-merger integration initiatives across life sciences and healthcare. He holds a Master of Science degree in International Business Administration from Maastricht University and an MBA from IESE Business School in Barcelona. “Under Rutger’s leadership, AMT has transformed from a bold technological concept into a clinically advancing platform with strong strategic potential,” said Idgar van Kippersluis, Chairman of the Supervisory Board. “As we approach a critical inflection point and anticipate significant clinical milestones that will transition the company from technology validation to regulatory and commercial preparation, this is the optimal moment to bring in a leader with Geert’s proven track record. He has successfully navigated the complete journey from preclinical development through regulatory approval to strategic exit, and we are confident he brings the expertise required to guide AMT through this next phase.” “I am honored to join AMT at a pivotal moment as the company prepares to enter its next phase of development,” said Geert van Gansewinkel. “AMT’s technology platform has significant potential to address fundamental challenges in coronary surgery. My immediate priorities will be preparing the organization for expected clinical milestones, establishing a clear regulatory pathway, scaling our clinical operations and operational infrastructure, and ensuring we build sustainable long-term value.” Rutger Tulleken added: “The technology foundation we have built over the past years positions AMT to make meaningful contributions to coronary surgery. As we approach important clinical updates that will define our path forward, this is the natural time to transition day-to-day leadership to someone with Geert’s specific expertise in taking medical technology companies from clinical validation through regulatory approval and commercial success. I look forward to continuing to contribute to AMT’s innovation roadmap, IP strategy, and strategic partnerships in my advisory capacity.” The company expects to provide detailed updates on its clinical programs and regulatory pathway in the coming months as key milestones are achieved. About AMT MedicalAMT Medical is a medical technology company developing a next-generation coronary bypass platform designed to simplify and standardize coronary artery bypass grafting (CABG) procedures. While coronary bypass surgery remains one of the most durable and clinically proven treatments for coronary artery disease, conventional approaches typically require invasive sternotomy and technically demanding hand-sewn anastomoses. This can limit reproducibility and broader adoption of minimally invasive techniques. AMT’s ELANA® Heart Bypass System is a technology designed to enable a simpler, standardized anastomosis technique, supporting reproducible outcomes in both open beating-heart and minimally invasive MIDCAB (minimally invasive direct coronary artery bypass) procedures. By facilitating standardized minimally invasive workflows, the platform aims to support a broader transition from conventional sternotomy-based CABG toward reproducible, less-invasive coronary revascularization, including its potential role in the evolution toward minimally invasive, hybrid, and robotic coronary surgery workflows. Headquartered in Ede, with laboratories in Utrecht, The Netherlands, AMT Medical collaborates with leading cardiac surgeons in The Netherlands, Charité – Universitätsmedizin Berlin in Germany, and in the United States with UChicago Medicine and Mayo Clinic, with the shared goal of initiating first-in-human clinical applications. AMT Medical has raised over $40 million to date, including a $25 million Series B round in 2025 led by Bender Analytical Holding B.V. and supported by Invest-NL, the European Innovation Council, and Oost NL, along with multi-million-euro grants from RVO and the EIC Accelerator, to advance regulatory approvals and clinical development. For more information, visit AMT-Medical’s website, or find us on Linkedin. For further background info, please contact: AMT-Medical, Ede/Utrecht, the NetherlandsGeert van Gansewinkel, CEOEmail: info@amt-medical.nl LifeSpring Life Sciences Communication, Amsterdam, the NetherlandsLeon MelensPhone: +31 6 538 16 427Email: lmelens@lifespring.bio
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Geert van Gansewinkel appointed as new CEO of AMT Medical