Commotio Cordis

LATHAM, N.Y.--( BUSINESS WIRE )--AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the publication of the results from the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI). The article, “Novel Mechanical Aspiration Thrombectomy in Patients with Acute Pulmonary Embolism: Results from the Prospective APEX-AV Trial,” was published December 27, 2024. Pulmonary embolism (PE), a potentially life-threatening condition, affects approximately 900,000 individuals annually in the United States, with 10-30% of cases resulting in death within one month of diagnosis, according to the American Lung Association. 1 The primary efficacy endpoint of the APEX-AV trial was the reduction in RV/LV ratio between baseline and 48 hours post-procedure. The primary safety endpoint was the rate of MAEs, including events such as major bleeding and serious device-related clinical deterioration, pulmonary vascular injury, and cardiac injury within the first 48 hours. Patients were followed for 30 days post-index procedure. The results demonstrated the device as a safe and effective treatment for acute intermediate-risk PE with a significant reduction in RV/LV ratio and clot burden with a low rate of adverse events. The APEX-AV trial demonstrated a 35.5% reduction in clot burden (via the Modified Miller index score), comparing favorably to other mechanical aspiration devices on the market. 2 The unique design features of the device, including its funnel tip, optional wireless navigation, and blood loss mitigation, contributed to clinically significant improvements in both safety and efficacy. "Achieving publication in a respected, peer-reviewed journal underscores the strength and importance of the APEX-AV trial findings and their potential impact on patient outcomes," said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. "The inclusion of the AlphaVac F18 85 System in JSCAI validates our commitment to advancing meaningful solutions for pulmonary embolism, a life-threatening condition affecting hundreds of thousands of people each year. This milestone caps a transformative year for the AlphaVac F18 85 System, following its FDA clearance for PE thrombectomy and its spotlight at the SCAI Scientific Sessions. We are proud to deliver innovations that equip physicians with effective tools to improve care and save lives." The APEX-AV trial was initiated in partnership with the widely respected Pulmonary Embolism Response Team (PERT) Consortium™ and was led by co-Principal Investigators William Brent Keeling, MD, Associate Professor at the Emory School of Medicine in Atlanta, Georgia, and Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA. The trial results were initially presented at The Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions hosted in Long Beach, California in May. “We are incredibly excited by the results of the APEX-AV trial, which demonstrate the safety and efficacy of the AlphaVac F18 85 System in treating patients with pulmonary embolism,” said William Brent Keeling, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate Past President, The PERT Consortium™. “These outcomes are critical for PE patients, where timely and efficient intervention can greatly improve long-term health outcomes and reduce the risk of complications.” In December 2023, AngioDynamics announced the completion of patient enrollment in its APEX-AV trial, a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States to assess the AlphaVac F18⁸⁵ System for the treatment of PE. In April 2024, the United States Food and Drug Administration (FDA) cleared the AlphaVac F18 85 System for the treatment of PE. “The results from the APEX-AV trial demonstrate the significant impact of the AlphaVac F18 85 technology in treating pulmonary embolism,” said Mona Ranade, MD, Assistant Professor, Interventional Radiology, at the David Geffen School of Medicine at UCLA. “We observed a significant reduction in clot burden pre- and post-treatment, and saw a notable improvement in pulmonary artery pressures, underscoring the efficacy of this innovative approach. The procedure was completed with remarkable efficiency, with a short procedure time, making it a promising option for patients in need of rapid and effective intervention.” The published article concluded that “Percutaneous mechanical aspiration thrombectomy with the AlphaVac system provided a safe and effective treatment for acute intermediate-risk PE with a significant reduction in RV/LV ratio and clot burden with a low rate of adverse events.” JSCAI publishes original research, comprehensive reviews, meta-analyses, study designs, society guidelines, editorials, research letters, case reports, and images. The subject matter includes all interventional subspecialities including coronary, peripheral, structural, and congenital heart disease. To access the published material, visit: https://www.sciencedirect.com/science/article/pii/S2772930324021525 . About the AlphaVac F18 85 System The AlphaVac F18 85 System is an emergent first-line device that is currently cleared for the removal of thromboemboli from the venous system and for the treatment of PE. The System includes an ergonomic handle, an 18F cannula with an 85-degree angle, an obturator and a waste bag assembly. The APEX-AV Study was designed to provide safety and efficacy data for a clearance specific to PE. For risk information, visit https://bit.ly/Angio-risk-info . About AngioDynamics, Inc. AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life. The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com . Safe Harbor This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign healthcare reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2024. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason. AngioDynamics, the AngioDynamics logo and AlphaVac are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners. ____________________________ 1 https://ihpi.umich.edu/news/pulmonary-embolism-deaths-disparities-high-despite-advancements-care 2 https://www.sciencedirect.com/science/article/pii/S2772930324021525

Now that the NFL preseason is firmly underway and fantasy football leagues are scrambling to sort out their draft picks, let's take revisit a moment from last football season that fans are unlikely to forget any time soon: The moment Buffalo Bills' defensive back Damar Hamlin collapsed on the field on live national television. Multiple specialists have since cleared Hamlin to return to football this season, ESPN reported in April. Officially, Hamlin was diagnosed with commotio cordis, a specific type of cardiac arrest. The American Heart Association describes commotio cordis as a very rare consequence of blunt force trauma to the heart at exactly the wrong time in the heart rhythm, causing the heart to stop beating. Aside from the trainers and first responders who rushed to Hamlin's aid, it could be argued that the MVP of that Jan. 2 game against the Cincinnati Bengals was the automated external defibrillator (AED) that helped save his life. Contrary to popular belief, defibrillators can only correct irregular heartbeat patterns, they cannot restart hearts. In Hamlin's case, the defibrillation delivered by the AED used by the team's trainer successfully converted Hamlin's rhythm to allow his heart to beat regularly again. Automated external defibrillators have become so common in public spaces that they may be easily overlooked. Brostock / iStock via Getty Images But there are many lessons to be learned from studying the evolution of the AED . AEDs are also an impressive example of voice prompts enhancing user interactions with a medical device. The latest-generation defibrillators use voice prompts to guide users through the numerous steps required to perform a successful rescue. Spoken instructions, such as "stay calm" and "check breathing," spare the rescuer from having to read textual or graphical instructions, which would be more time-consuming and could create confusion. The world's first portable defibrillator was launched by the Royal Victoria Hospital-Belfast in Ireland under the direction of doctors Frank Pantridge and John Geddes. “Pantridge’s vision in the 1950s was that a defibrillator should be beside every fire extinguisher,” Dewar Finlay, interim associate dean of the school of engineering at Ulster University, told MD+DI in an interview in March 2022. Although they had developed a mobile cardiac care unit, it was not convenient to use, as it weighed 110 lb. This was mainly due to the lack of miniaturized electronic components, particularly those required to power a defibrillator and provide the electrical energy needed to produce the required shock. The research team, which formed the company, HeartSine in 1988, now owned by Stryker, continued to refine the device to make it more lightweight and portable. Read on to learn the role that rapid prototyping and user-centric design played in the evolution of the automated external defibrillator.

WASHINGTON, June 20, 2023 /PRNewswire/ -- On behalf of the Association of Black Cardiologists (ABC), we extend our heartfelt well wishes and unwavering support to National Football League (NFL) player Damar Hamlin, who experienced a sudden cardiac event early this year. We recognize the gravity of this event and its impact on him, the NFL community, the country, and the world. Damar's strength and resilience are commendable, and his dedication to sudden cardiac death awareness is inspiring. While our team members were not directly involved in his evaluation, we agree that a diagnosis of commotio cordis is the most likely if a comprehensive cardiac evaluation was normal. Commotio cordis occurs when there is an untimely, focal, high-velocity impact to the chest wall during a narrow, vulnerable period of the cardiac cycle. This diagnosis is extremely rare, and can occur in a normal heart. The decision regarding the resumption of competitive sports should be predicated upon a meticulous appraisal of Damar's specific condition, the underlying etiology of the cardiac event, and the potential risks at stake. The ABC ardently advocates for the principles of shared decision-making in sports cardiology, wherein medical professionals collaborate with the athlete, their family, the organization, and a multidisciplinary team to ascertain the safest course of action regarding return-to-play. With appropriate medical care, rehabilitation, and understanding of risk, we support him returning to the NFL if he so wishes. Additionally, we pray that he receives the full support of the NFL and the nation for his psychological recovery. Sudden cardiac death (SCD) is a complex event with many potential underlying mechanisms that may lead to a sudden cessation of effective cardiac pumping and loss of pulse. In individuals predisposed to SCD, the pathophysiology involves a combination of structural abnormalities of the heart, inherited cardiac conditions, and electrical disturbances. In an attempt to detect cardiac abnormalities that increase an athlete's risk of exercise-related SCD, preparticipation evaluations (PPE) can be helpful. However, despite best efforts and screening, tragic events may still occur. Once abnormalities are identified on screening, appropriate downstream testing is required. It is crucial to acknowledge the disparities that exist in the diagnosis of predisposing conditions related to SCD. Specific populations, particularly Black individuals, face inequities in accessing comprehensive downstream cardiac evaluations, including imaging, stress testing, genetic testing, and advanced invasive diagnostic modalities. This can impede the identification of underlying cardiac conditions, thereby hindering targeted prevention strategies. Furthermore, disparities in sudden cardiac arrest and resuscitation outcomes have been observed, with lower survival rates among certain racial and ethnic groups. Epidemiological studies, including that by the National Collegiate Athletic Association (NCAA), have highlighted Black male athletes as the highest-risk individuals compared to white athletes. To date, there has been no biological explanation for these discrepancies. The ABC asserts that addressing adverse social determinants of health is necessary to achieve equitable healthcare and rectify these disparities to ensure the well-being of all athletes. It is essential to acknowledge the excellent, immediate resuscitation that Damar Hamlin received on an NFL field with athletic trainers skilled in cardiopulmonary resuscitation (CPR), automated external defibrillator (AED) use, and emergency medical transport. It exemplified the well-executed emergency action plan (EAP) that every sporting facility and organization is encouraged to have. Unfortunately, millions of student-athletes throughout this country are not afforded these resources, mainly in impoverished environments especially in Black and Hispanic communities. Lack of athletic trainers and functioning AEDs leads to less survival among these athletes. The ABC endorses and supports the Access to AEDs Act. This bipartisan bill will increase access to life-saving equipment, CPR education, and training for schools nationwide to improve outcomes of sudden cardiac arrest for all. The ABC remains unwavering in our commitment to raising awareness regarding sudden cardiac risk in athletes, promoting comprehensive cardiac evaluations regardless of socioeconomic background, and advocating for equitable access to cardiac care. We implore athletes, sports organizations, medical professionals, and the wider community to unite in mitigating the risks associated with sports-related cardiac events, thereby ensuring the safety and well-being of all athletes. Merije Chukumerije, MD; ABC member, Sports Cardiology specialist; Marlon E. Everett, MD, Co-Chair, ABC Communications Committee; Camille G. Frazier-Mills, MD, MHS, Co-Chair, ABC Electrophysiology Committee; Aubrey J. Grant, MD, ABC member, Sports Cardiology specialist; G. Mark Jenkins, MD, Co-Chair, ABC Advisory Group and Former ABC Board Member; Kevin F. Kwaku, MD, PhD, ABC Board Member and Co-Chair, ABC Electrophysiology Committee; Jayne Morgan, MD, Co-Chair, ABC Communications Committee; Anekwe E. Onwuanyi, MD, President of ABC; and Barbara Hutchinson, MD; ABC Board Chair. About ABC Founded in 1974, the ABC is a nonprofit organization dedicated to eliminating the disparities related to cardiovascular disease and achieving health equity such that all people can live long healthy lives. Membership is open to all interested in the care of people with or at risk for cardiovascular disease, including health professionals, lay members of the community (Community Health Advocates), corporate and institutional members. Today, the ABC's public and private partnerships continue to increase its impact in communities across the nation. For more information, visit and wearethefaces.abcardio.org or connect with ABC on Twitter, Facebook, Instagram, and LinkedIn. Contact: ABC Media Relations [email protected] 646-689-0659 SOURCE Association of Black Cardiologists