Ventricular Fibrillation

TOKYO, Japan & MUNICH, Germany I November 09, 2023 I Daiichi Sankyo’s (TSE: 4568) VANFLYTA ® (quizartinib) has been approved in the European Union (EU) for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 -ITD positive. VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3 -ITD positive AML, which represents about 25 to 30% of all new AML cases. 1,2 The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet . In QuANTUM-First, VANFLYTA combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; p=0.032]) in patients with newly diagnosed FLT3 -ITD positive AML. Median overall survival was 31.9 months for patients receiving VANFLYTA (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months. “This approval of VANFLYTA represents an important advancement for frontline treatment of patients with FLT3 -ITD positive acute myeloid leukemia, an aggressive and historically difficult-to-treat subtype,” said Richard F. Schlenk, MD, Professor and Head of the Trial Center of the National Center of Tumour Diseases, Heidelberg University Hospital and German Cancer Research Center, Germany. “VANFLYTA is a potent and selective FLT3 inhibitor that significantly improved overall survival when added to standard chemotherapy and it will be a valuable treatment option for newly diagnosed FLT3 -ITD positive AML.” “This approval of VANFLYTA is very welcome news for eligible patients diagnosed with FLT3 -ITD positive AML each year,” said Samantha Nier, Network Director, Acute Leukemia Advocates Network (ALAN). “New medicines and treatment approaches are needed to help patients with this difficult type of leukemia live longer, and we look forward to VANFLYTA becoming available in countries throughout the EU.” The safety profile of VANFLYTA in QuANTUM-First was consistent with previous clinical trials with no new safety signals observed. The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%). QTcF > 500 ms occurred in 2.3% of patients receiving VANFLYTA and 0.8% of patients discontinued VANFLYTA due to QT prolongation. Ventricular arrhythmia events with VANFLYTA were uncommon. Two (0.8%) patients receiving VANFLYTA experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia. “With the approval of VANFLYTA in the European Union, patients diagnosed with FLT3 -ITD positive acute myeloid leukemia may for the first time receive a targeted therapy developed and approved specifically for their disease subtype,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “VANFLYTA is the second innovative medicine from our oncology pipeline approved in the EU and its successful development reflects our commitment to creating new standards of care for patients with cancer.” About QuANTUM-First QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating VANFLYTA in combination with standard induction and consolidation therapy, including hematopoietic stem cell transplant (HSCT), and as maintenance monotherapy, in adult patients aged 18-75 with newly diagnosed FLT3 -ITD positive AML. Patients were randomized 1:1 to receive VANFLYTA or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of treatment with single-agent maintenance. The primary study endpoint was overall survival. Secondary endpoints include event-free survival, post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3 -ITD measurable residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints including duration of CR also were evaluated. QuANTUM-First enrolled 539 patients at 193 study sites in 26 countries across Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov . About FLT3 -ITD Positive Acute Myeloid Leukemia More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths. 3 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults. 4,5 In Europe, approximately 18,000 people are diagnosed with AML each year and the five-year survival rate is reported at 17% for adult patients. 6,7 A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common. 8 Approximately 80% of FLT3 mutations are FLT3 -ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis including increased risk of relapse and shorter overall survival. 1,2 FLT3 -ITD mutations occur in about 25% of all AML cases, with frequency reported as high as 30%. 1,2 About VANFLYTA VANFLYTA is an oral, highly potent type II FLT3 inhibitor that selectively targets FLT3 -ITD mutations and has been specifically developed for patients with FLT3- ITD positive AML. 2 VANFLYTA is approved in the EU in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed AML that is FLT3 -ITD positive. VANFLYTA is approved in the U.S. in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3 -ITD positive as detected by an FDA-approved test. VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated. VANFLYTA also is approved in Japan for the treatment of AML that is FLT3 -ITD mutation positive, including for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapy for adult patients with newly diagnosed FLT3 -ITD positive AML and as a monotherapy for relapsed/refractory AML that is FLT3 -ITD positive as detected by an approved test. VANFLYTA is an investigational medicine in all countries outside of Europe, Japan and the U.S. About the VANFLYTA Clinical Development Program The VANFLYTA clinical development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3 -ITD positive AML in Europe and North America and several phase 1/2 combination studies as part of a strategic collaboration with The University of Texas MD Anderson Cancer Center. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com References: 1 Daver N, et al. Leukemia . (2019) 33:299-312. 2 Patel JP, et al N Engl J Med . (2012) Mar 22;366(12):1079-89. 3 Global Cancer Observatory. Population Fact Sheet: World . Updated March 2021. 4 American Cancer Society: Key Statistics for Acute Myeloid Leukemia . Updated January 2023. 5 Dong Y, et al. Exp Hematol Oncol . (2020);9:14. 6 Rodriguez-Abreu D, et al. Ann Oncol (2007);18 Suppl 1:i3-i8. 7 Heuser M, et al. Ann Oncol . (2020) 31(6):697-712. 8 Kennedy VE, et al. Front Onc . 23 December 2020;10. Volume 10 – 2020. SOURCE: Daiichi Sankyo

First-of-its-kind Aurora EV-ICD™ system offers single device, single procedure with lead placed outside of heart and veins DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the Aurora EV-ICD™ MRI SureScan™ (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV™ MRI SureScan™ defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). The Aurora EV-ICD system is the first-of-its-kind to provide the life-saving benefits of traditional, transvenous ICDs with a lead (thin wire) placed under the breastbone, outside of the heart and veins. The Aurora EV-ICD delivers lifesaving defibrillation, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies via a device similar in size, shape, and longevity to traditional, transvenous ICDs. Continue Reading Medtronic Aurora EV-ICD™ system animation Medtronic Aurora EV-ICD™ system Medtronic Aurora EV-ICD™ system FDA approval of the Medtronic Aurora EV-ICD system includes the system's proprietary procedure implant tools, and was supported by global pivotal trial results showing the system's safety and effectiveness, which were published in The New England Journal of Medicine. In the coming weeks, the Aurora EV-ICD system will be commercially available on a limited basis in the United States. "The Aurora EV-ICD system is a tremendous step forward in implantable defibrillator technology," said Bradley P. Knight, M.D., medical director of Electrophysiology at Northwestern Medicine Bluhm Cardiovascular Institute and a co-author of the study. "Placing the leads outside of the heart, rather than inside the heart and veins, reduces the risk of long-term complications, ultimately allowing us to further evolve safe and effective ICD technology." In the pivotal study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7%, and there we no major intraprocedural complications, nor any unique complications observed related to the EV ICD procedure or system compared to transvenous and subcutaneous ICDs.[1] Additionally, 33 defibrillation shocks were avoided1 by having ATP – which paces the heart to interrupt and terminate a dangerous rhythm – programmed "on." And at six months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death.1 ICDs are highly effective in providing life-saving therapy for patients at risk of SCA, an electrical problem with the heart due to a dangerously fast heart rate (ventricular tachycardia) or irregular rhythm (ventricular fibrillation). If not treated immediately, SCA is often fatal (termed sudden cardiac death). Traditional ICDs typically are implanted below the collarbone, with the lead(s) threaded through the veins and into the heart. "This FDA approval paves the way for patients to have a better overall experience with ICD therapy," said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "ICDs remain the gold standard for prevention of sudden cardiac death, and while the subcutaneous ICD avoids certain complications associated with transvenous defibrillators, it has limitations that may affect a patient's comfort and quality-of-life. With the Aurora EV-ICD system, patients can benefit from the only ICD placed outside the vascular space that provides ATP and back-up pacing, in a device that is nearly half the size and with 60% greater projected battery longevity compared to the competitor's subcutaneous ICD." The Aurora EV-ICD system is similar in size, shape, and longevity to traditional, transvenous ICDs. Unlike traditional ICDs, the Aurora EV-ICD system is implanted below the left armpit (in the left mid-axillary region) and the lead is placed under the breastbone (sternum) using a minimally invasive approach. The Epsila EV defibrillation lead is placed outside of the heart and veins, helping to avoid certain complications associated with transvenous leads, such as vascular injury and vessel occlusion (narrowing, blockage or compression of a vein). The Aurora EV-ICD system includes features available in Medtronic transvenous ICDs, and offers additional advantages that are not available with the subcutaneous ICD including: Anti-tachycardia Pacing (ATP), to terminate ventricular arrhythmias (rapid and/or chaotic activity of the heart that can lead to SCA) using low-energy pacing pulses, potentially avoiding a defibrillation shock. Pause Prevention Pacing, to provide back-up pacing for brief, intermittent, heartbeat pauses. 40 Joule Defibrillation Energy, to deliver life-saving shocks in a device the size of transvenous ICDs (33 cc) Medtronic exclusive PhysioCurve™ design, to increase patient comfort and implant acceptance. 11.7-year projected longevity, to reduce device replacement procedures during a patient's lifetime. Patients who receive the commercially available Aurora device also will benefit from the addition of Smart Sense, a proprietary algorithm designed to reduce the potential for inappropriate shocks. Medtronic will obtain real-world performance and safety data on the Aurora system in the Enlighten global post-approval registry, a prospective, non-randomized, observational, multicenter study, expected to last five years and enroll approximately 1,000 patients. First implants in Enlighten and first commercial implants worldwide were recently conducted by Lucas V.A. Boersma, M.D., Ph.D., cardiologist at St. Antonius Hospital, Nieuwegein, The Netherlands, and a limited launch is underway in select European countries. The Aurora EV-ICD system is indicated for patients who are at risk of life-threatening arrhythmias, and who have not had a prior sternotomy and do not need chronic bradycardia (abnormally slow heartbeat) pacing. About the EV ICD Pivotal Study The EV ICD Pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death. It enrolled 356 patients at 46 sites in 17 countries in North America, Europe, the Middle East, Asia, Australia and New Zealand, and results were published in The New England Journal of Medicine. Safety and effectiveness results were sustained out to 18 months.2 About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit and follow @Medtronic on Twitter and LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. -end- ______________________________________________ 1Friedman P, Murgatroyd F, Boersma LVA, et al. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator. N Engl J Med 2022; 387:1292-1302. 2Friedman P, Murgatroyd F, Boersma LVA, et al. Chronic Safety and Performance of the Extravascular ICD: Results from the Global EV ICD Pivotal Study. Heart Rhythm Society late breaking clinical trials, May 20, 2023. SOURCE Medtronic plc

DUBLIN, Oct. 20, 2023 /PRNewswire/ -- The "Cardiac AI Monitoring and Diagnostics Market - A Global and Regional Analysis: Focus on Product, Type, Application, End User, and Country Analysis - Analysis and Forecast, 2023-2032" report has been added to ResearchAndMarkets.com's offering. The global cardiac AI monitoring and diagnostics market was valued at $1,010.5 million in 2022 and is anticipated to reach $10,666.5 million by 2032, witnessing a CAGR of 26.88% during the forecast period 2023-2032. Cardiac AI monitoring and diagnostics involve the application of artificial intelligence (AI) technologies in the field of cardiology to monitor, analyze, and diagnose various cardiac conditions. AI algorithms are trained using extensive datasets of cardiac images, patient data, and clinical outcomes to create models that can assist healthcare professionals in interpreting cardiac diagnostic tests and making treatment decisions. This emerging medical technology aims to enhance the accuracy, efficiency, and accessibility of cardiac care. Several key factors are driving the growth of the global cardiac AI monitoring and diagnostics market. These include the significant burden of cardiovascular diseases worldwide, increasing government initiatives to promote AI adoption, growing research in AI for cardiology, rising regulatory approvals for AI-based cardiac diagnostic medical devices, and ongoing technological advancements in the field of cardiac AI diagnostics. The North American region holds the largest share in the global cardiac AI monitoring and diagnostics market. This can be attributed to factors such as an already established and technologically advanced healthcare system and high levels of digital adoption. Additionally, the Asia-Pacific region is expected to experience substantial growth during the forecast period from 2023 to 2032. This growth is driven by factors like a shortage of healthcare professionals leading to increased demand for AI-driven automation and the rising prevalence of cardiovascular diseases, which is driving demand for advanced technologies. During the COVID-19 pandemic, AI technology played a crucial role in predicting congestive heart failure in COVID-19 patients by analyzing vital signs related to heart disease. It also assisted in assessing patients' medical history and recommending appropriate medications for treatment. Furthermore, the pandemic underscored the advantages of implementing AI in cardiology. As a result, the COVID-19 crisis had a positive impact on the overall cardiac AI monitoring and diagnostics market, as it heightened the focus on remote monitoring, increased demand for early detection and proactive care, and accelerated technological advancements in cardiac diagnosis and monitoring. Market Segmentation Software to Dominate the Global Cardiac AI Monitoring and Diagnostics Market Software: Software plays a critical role in the development of AI-based medical devices. AI-based medical devices rely on sophisticated software tools that are designed to analyze medical data, images, and other inputs to provide accurate monitoring, diagnosis, and provide treatment recommendations. These software tools typically include machine learning and deep learning algorithms that are trained on large datasets of medical images and clinical data to identify patterns and predictions. Hardware: Hardware for cardiac monitoring and diagnosis includes the combination of artificial intelligence (AI) algorithms and specialized hardware devices designed to enhance the accuracy, efficiency, and accessibility of cardiac healthcare. These hardware devices are specifically developed to integrate AI capabilities into the monitoring and diagnostic processes, enabling advanced data analysis, real-time insights, and improved patient care. Cardiac Diagnostics Occupy the Largest Share in the Global Cardiac AI Monitoring and Diagnostics Cardiac Diagnostics: Cardiac diagnostics refers to the process of identifying and determining the presence, nature, and extent of cardiac diseases or abnormalities in an individual. The goal of cardiac diagnosis is to accurately identify the underlying cardiac condition, which helps guide appropriate treatment and management strategies. The integration of artificial intelligence (AI) into cardiac diagnosis involves leveraging AI algorithms and techniques to augment and enhance the diagnostic process. It has the potential to enhance accuracy, efficiency, and accessibility while supporting healthcare professionals in providing optimal care to patients. AI can help in cardiac diagnosis by performing data analysis of large volumes of cardiac data, including medical records, images, test results, and patient characteristics, analyzing medical images, such as echocardiograms, angiograms, or cardiac MRI scans, analyzing electrocardiogram (ECG) signals to detect and classify various arrhythmias and other cardiac abnormalities, or by providing AI-based decision support. Cardiac Monitoring: Cardiac monitoring refers to the continuous or periodic monitoring of a patient's heart activity, typically through the use of specialized devices or systems. It involves the recording, analysis, and interpretation of various cardiac parameters to assess heart function, detect abnormalities, and monitor cardiac conditions. The integration of AI into monitoring devices or systems enhances the accuracy, efficiency, and insights derived from the collected data. By leveraging AI algorithms, healthcare professionals can gain a deeper understanding, make timely interventions, and provide more targeted care to individuals with cardiac conditions, ultimately improving patient outcomes and quality of life. Ischemic Heart Diseases/CAD Segment to Hold the Highest Share of the Market due to the High Prevalence Ischemic Heart Diseases/CAD: Ischemic heart disease, also known as coronary artery disease (CAD), is a condition that occurs when the blood vessels supplying blood to the heart (coronary arteries) become narrowed or blocked, leading to reduced blood flow and oxygen to the heart muscle. CAD is the most common type of heart disease and a leading cause of heart attacks. The primary cause of CAD is atherosclerosis, a condition characterized by the buildup of plaque on the inner walls of the coronary arteries. Plaque consists of cholesterol, fat, calcium, and other substances. Over time, the plaque can harden and narrow the arteries, restricting blood flow. The increased prevalence of ischemic heart disease is fueling the demand for advanced solutions for monitoring and diagnosis, which is expected to propel the growth of the segment. Cardiac Arrhythmias: Cardiac arrhythmia refers to abnormal heart rhythms or irregular heartbeats. The normal rhythm of the heart is maintained by electrical signals that coordinate the contractions of the heart's chambers. When these electrical signals are disrupted, it can lead to various types of arrhythmias. Some common types of arrhythmias include atrial fibrillation (AF), ventricular tachycardia (VT), ventricular fibrillation (VF), supraventricular tachycardia (SVT), bradycardia, and premature ventricular contractions (PVCs). Ischemic Stroke: An ischemic stroke is the most common type of stroke, accounting for about 80% of all strokes. It occurs when a blood clot or plaque buildup blocks or narrows a blood vessel, reducing or completely cutting off blood flow to a part of the brain. Without an adequate blood supply, the affected brain tissue is deprived of oxygen and nutrients, leading to damage and cell death. Others: The others segment consists of other cardiac conditions such as hypertensive heart diseases, cardiomyopathy, valvular heart diseases, congenital heart diseases, and peripheral artery diseases, among others. AI has great potential to significantly impact the diagnosis and monitoring of these cardiac diseases, and several market players are working toward the implementation of AI for the diagnosis and monitoring of different cardiac diseases. Hospitals to Dominate the Global Cardiac AI Monitoring and Diagnostics Market (by End User) Based on end users, the hospital segment is expected to dominate the cardiac AI monitoring and diagnostics market. The hospitals segment held a share of 58.22% in 2022 and is expected to grow at a CAGR of 26.06% during the forecast period 2023-2032. Hospitals are one of the primary end users of the cardiac AI monitoring and diagnostics market. By leveraging AI technology, these devices can assist healthcare professionals in detecting abnormalities, predicting cardiac events, and aiding in the diagnosis of various cardiac conditions Business Dynamics Business Drivers High Burden of Cardiovascular Diseases Worldwide Increasing Government Initiatives for AI Adoption Growing Research in the Field of AI for Cardiology Increasing Regulatory Approvals of Cardiac Diagnostics AI Medical Devices Technological Advancements in the Field of Cardiac AI Diagnostics Business Restraints Hesitation in Adoption and Acceptance of AI-Enabled Solutions for Cardiac Diagnosis Business Opportunities Increasing Opportunities for AI-Enabled Cardiac Diagnosis Solutions in Emerging Economies Partnerships and Alliances amongst Market Players Creating an Opportunity for Growth Key Trends Rising Number of Startups in the Market Increased Awareness Regarding Preventative Measures and Personalized Treatment Growing Demand for Wearable Sensors for Cardiac Monitoring Leading to Increased Adoption of AI-Enabled Solutions for Home-Based Care Key Companies Profiled: AliveCor Inc. Aidoc Boston Scientific Corporation Canon Inc. CathWorks Circle Cardiovascular Imaging Inc. General Electric Company HeartFlow, Inc. iRhythm Technologies, Inc. Koninklijke Philips N.V. Medicalgorithmics S.A. Nanox.AI Ltd. Siemens Healthineers AG Tempus Labs, Inc. Ultromics Limited. Viz.ai, Inc. Case Studies Case Study 1: Ultromics Limited The EchoGo System Developement Use Case and Reliability A Success Story Partners and Recognitions Case Study 2: CorVista Health, Inc. The CorVista System A Success Story Ongoing Clinical Trials Funding Scenario End User Perception Entry Barriers for New Entrants Patent Analysis Awaited Technological Developments Patent Analysis (by Country) Patent Analysis (by Year) Business Models Cardiac AI Monitoring and Diagnostics Market Impacts Improved Accuracy and Efficiency Early Detection of Heart Condition Remote Patient Monitoring Personalized Treatment Plans Bridging Healthcare Gaps Research and Development Cost Savings Impact of COVID-19 Impact on the Overall Market Pre-COVID-19 Scenario During COVID-19 Scenario Post COVID-19 Scenario For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. 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