AtriCure, Inc.

VANCOUVER, BC, Aug. 28, 2024 /PRNewswire/ - In a world, where cardiovascular diseases (CVDs) remain a leading cause of death, the global cardiac surgery market has emerged as a cornerstone of life-saving interventions, driven by innovations in medical technology. According to iData Research's (iData) latest suite of reports, the global cardiac surgery market was valued at over $17 billion in 2023 and is projected to experience a robust growth, reaching almost $25 billion by the end of the forecast period. Continue Reading Figure 1: Forecasted Market Value of the Global Cardiac Surgery Device Market between 2023 and 2030 (CNW Group/iData Research Inc.) Figure 2: Cardiovascular Disease (CVD) Deaths Annually in Europe and on a global scale. (CNW Group/iData Research Inc.) Figure 3: Atricure’s AtriClip Flex V Device revenue growth, Q1/2018 to Q2/2023. (CNW Group/iData Research Inc.) Cardiac surgery devices are fundamental tools in combating the increasing global burden of cardiovascular diseases. From tissue and mechanical heart valves to highly advanced transcatheter heart valve replacement (THVR) devices, the global market offers a wide array of solutions. Key devices in this market also include annuloplasty repair devices, transcatheter mitral valve repair (TMVr) devices, cerebral embolic protection devices, coronary artery bypass devices (ONCAB and OPCAB), ventricular assist devices (VADs), and extracorporeal membrane oxygenation (ECMO) systems. Comprehensive Overview of Cardiovascular Disease Cardiovascular diseases continue to dominate the landscape of global health crises. According to the World Health Organization, CVD causes over 17 million deaths annually, representing a staggering 32% of all global deaths. Coronary artery disease (CAD) and cerebrovascular disease are the primary drivers of these CVD-related fatalities. In the U.S., an estimated 9.8 million Americans live with angina, with approximately 500,000 new cases emerging each year. Additionally, heart disease disproportionately impacts certain ethnic groups, with White (Non-Hispanic), Native Hawaiian/Pacific Islander, and Black (Non-Hispanic) communities experiencing heart disease death rates of over 20%. Europe faces a similarly dire situation. The European Heart Journal reports that CVDs are responsible for more than 4 million deaths annually across the continent, accounting for nearly 45% of all fatalities. Central and Eastern Europe are particularly affected, with the highest CVD mortality rates in Europe. In the European Union alone, the economic burden of CVD is estimated at a staggering €210 billion per year. Asia-Pacific is also witnessing an alarming rise in CVD cases, particularly in China and Japan. In China, urbanization, lifestyle changes, and an aging population have contributed to CVD accounting for over 40% of annual deaths, with over 290 million people affected. Japan, home to the world's oldest population, is experiencing heightened demand for cardiovascular treatments due to the increasing prevalence of heart-related ailments. Key Market Segments and Emerging Trends The global cardiac surgery market is dominated by key regions, with North America leading the charge, followed by Western Europe and Asia-Pacific. North America continues to be the largest market for cardiac surgery devices, but as growth plateaus, companies are increasingly turning their attention to emerging markets in Asia-Pacific, Eastern Europe, and Latin America, where the demand for cardiovascular treatments is surging. Transcatheter heart valve replacement (THVR) devices have secured their position as the largest market segment, with strong growth anticipated due to increasing unit sales. However, the introduction of transcatheter aortic valve replacements (TAVRs), also known as transcatheter aortic valve implantation (TAVI), as a first-choice therapy is exerting pressure on other segments, such as transcatheter pulmonary valve replacements (TPVRs), which are expected to experience slower growth. A major trend reshaping the landscape is the shift towards minimally invasive surgery, which is revolutionizing patient care and procedural efficiency. Technologies like TAVI/TAVR and transcatheter mitral valve repair (TMVr) are poised to drive significant gains in the coming years, as they offer less invasive alternatives to traditional open-heart surgeries. The TAVI/TAVR market, in particular, is expected to see strong expansion, fueled by the pressing need for this therapy among a growing patient population. Likewise, the TMVr market is projected to increase its market share, as it addresses the substantial demand for mitral valve repair without requiring open-heart surgery. Untapped Potential in the LAA Closure Device Market The left atrial appendage (LAA) closure device market is poised for significant expansion as new companies enter the space, driving heightened competition and downward pressure on pricing. Currently, there are a limited number of companies active in this segment, but increasing interest from additional players is reshaping the landscape. AtriCure has experienced exponential growth, particularly with their AtriClip Flex V Device, as revenue skyrocketed between 2018 and 2023, according to iData's U.S. MedSKU data. As more patients are identified with the clotting risk associated with the LAA, the market value for closure devices is expected to rise sharply. Additionally, routine exams to check for clots in the LAA are becoming increasingly common worldwide. As health systems continue to evolve and this practice expands, the number of patients identified with clot risks will only grow, further fueling demand for LAA closure devices. Market Share Leaders Major players are fiercely competing for market share globally, with Edwards Lifesciences emerging as the dominant force in 2023. Despite only competing in four segments, Edwards Lifesciences leads the market in all but one. Abbott, the second-leading competitor, is a giant in the medical device world, poised to increase its market share across a wide range of cardiac surgery devices. Medtronic, another key player, commands significant presence in numerous device categories and is expected to maintain its stronghold as the market evolves. Other notable competitors in the global cardiac surgery device market included Abiomed, Boston Scientific, Getinge, LivaNova, Terumo, Gore, AtriCure, Artivion, Becton Dickinson, Syncardia, and more. In Summary With shifting trends towards minimally invasive procedures, innovations in TAVI/TAVR and TMVr devices are set to shape the future of cardiac care. As healthcare providers and patients alike demand more efficient and less invasive treatments, these devices are at the forefront of a new era in cardiac surgery. For a comprehensive analysis of the Global, European, and U.S. cardiac surgery markets, explore our in-depth reports that delve into the latest trends, competitive dynamics, and market forecasts shaping the future of this vital industry. About iData iData Research stands out as the premier MedTech market research and intelligence provider, offering unparalleled insights and comprehensive data analysis across a multitude of industries. With a strong reputation and a proven track record, iData Research has solidified its position as the best choice for businesses seeking to make informed decisions in today's dynamic medical market landscape. SOURCE iData Research Inc.

MASON, Ohio--( BUSINESS WIRE )-- AtriCure, Inc. ( Nasdaq: ATRC ), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that the first patient was treated with the AtriClip ® FLEX-Mini™ device, which recently received 510(k) clearance. The AtriClip FLEX-Mini sets a new standard as the smallest profile surgical LAA device on the market and builds upon the proven technology of AtriCure’s AtriClip platform, with ease of use and design simplicity that offers enhanced access and increased visibility for physicians. “The AtriClip FLEX-Mini is an unparalleled product that reinforces our position as the market leader in surgical LAA management,” said Michael Carrel, President and Chief Executive Officer at AtriCure. “With nearly 600,000 AtriClip devices sold globally, we are having a significant impact on patients’ lives. Continuing to innovate and enhance the unique features of our AtriClip platform will support even greater growth in this market.” The AtriClip FLEX-Mini, the smallest surgical LAA device available in the market, incorporates the trusted elements of the AtriClip portfolio, featuring a fully enclosed design with parallel beams for continuous closing force, ensuring optimal pressure on atrial tissue. The low-profile design enhances visibility without compromising stability, providing physicians with unprecedented control during procedures. Additionally, the device's ergonomic handle design enables single-handed placement, further simplifying the application process. “The AtriClip FLEX-Mini is a significant step forward in ensuring patients receive the best possible treatment,” said Dr. Ibrahim S. Sultan, MD, Professor and Chief, Division of Cardiac Surgery, University of Pittsburgh Medical Center. “This device builds off the first- and second-generation platforms, which established an incredible record of clinical outcomes. With surgical LAA management now having the highest-level recommendation for treatment from multiple physician societies, this new technology will make it even easier for my surgeon colleagues to choose mechanical appendage closure.” For more information about the AtriClip line of products, visit our website at www.atricure.com/laa-exclusion Forward-Looking Statements This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. Actual results could differ materially. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/forward-looking-statements as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We assume no obligation to update any forward-looking statements contained in this release and the related attachment as a result of new information or future events or developments, except as may be required by law. About AtriCure AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide. Electrophysiologists, cardiothoracic and thoracic surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications and post-operative pain management. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

MASON, Ohio--( BUSINESS WIRE )-- AtriCure, Inc. ( Nasdaq: ATRC ), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that it has received an expanded indication for the AtriClip ® in CE-marked countries in Europe. The product is now indicated for use in patients at high risk of thromboembolism for whom left atrial appendage exclusion is warranted. The AtriClip family of devices are innovative solutions designed to exclude, electrically isolate, and eventually eliminate the left atrial appendage during cardiac surgery. The LAA is a major source of blood clots in patients with Afib, and this expanded indication is a result of a significant body of clinical evidence and real-world experience that demonstrates a reduction in stroke events for patients who receive an AtriClip device. “This new indication is tremendous validation of our AtriClip device,” said Michael Carrel, President and CEO of AtriCure. “With over 550,000 patients successfully treated worldwide, we have seen the impact that our devices have on patient care. The expanded indication from the European Commission confirms our own clinical evidence that strokes can be reduced in patients who are at high risk of developing thromboembolism, and we continue to see strong opportunity to grow adoption of mechanical appendage closure.” Since the first AtriClip device was used in 2007, there have been over 85 peer-reviewed studies published on both acute and long-term safety and efficacy. This represents over 11,000 patients who were studied across multiple geographies. “I’ve been using AtriClip devices for over a decade and have seen firsthand the benefits of its safety and efficacy,” said Professor Dr. Med. Nicolas Doll, Chief Physician of Cardiac Surgery, Schuechtermann-Clinic, Bad Rothenfelde, Germany. “The devices are easy to use, and they provide patients with the benefit of long-term prevention of stroke, which makes adoption of the AtriClip an easy decision.” Forward-Looking Statements This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. Actual results could differ materially. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/forward-looking-statements as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We assume no obligation to update any forward-looking statements contained in this release and the related attachment as a result of new information or future events or developments, except as may be required by law. About AtriCure AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide. Electrophysiologists, cardiothoracic and thoracic surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications and post-operative pain management. AtriCure’s Isolator ® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip ® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE ® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on X (formerly Twitter) @AtriCure .