ST Elevation Myocardial Infarction

DUBLIN, Jan. 16, 2024 /PRNewswire/ -- The "Abiomed Inc - Product Pipeline Analysis, 2023 Update" company profile has been added to ResearchAndMarkets.com's offering. Abiomed Inc (Abiomed) is a medical device company that develops, manufactures, and markets circulatory support devices. The devices replace or assist the pumping function in a failing heart. The company's heart support and recovery product portfolio includes Impella heart pumps (catheter-based devices including micro heart pumps, expandable catheter pumps and axial flow pumps) and Breethe system (implantable cardiac and respiratory assist devices). Abiomed also offers online clinical support through Impella Connect, on-call assistance and on-site assistance for health workers in hospitals. The company sells its products through direct sales and distributors in South America, Europe, Asia, and the Middle East. Abiomed is headquartered in Danvers, Massachusetts, the US. This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands. Report Scope: The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments The report analyzes all pipeline products in development for the company Abiomed Inc The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status) The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date The report provides detailed description of products in development, technical specification and functions The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date. Key Report Benefits: Develop business strategies by understanding the trends and developments driving the medical devices pipeline and technology landscape Design and develop your product development, marketing and sales strategies by understanding the competitor portfolio To formulate effective Research & Development strategies Develop market-entry and market expansion strategies Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage Develop competition strategies by identifying the status and likely launch of the competitors' pipeline products through review of the clinical trials, stage and of development, etc Identify, understand and capitalize the next high-value products that your competitor would add in its portfolio Key Topics Covered: Abiomed Inc Abiomed Inc Company Snapshot Abiomed Inc Pipeline Products and Ongoing Clinical Trials Overview Abiomed Inc - Pipeline Analysis Overview Business Description Abiomed Inc - Key Facts Abiomed Inc - Major Products and Services Abiomed Inc Pipeline Products by Development Stage Abiomed Inc Ongoing Clinical Trials by Trial Status Abiomed Inc Pipeline Products Overview AbioCor II AbioCor II Product Overview Abiomed Breethe OXY-1 System Abiomed Breethe OXY-1 System Product Overview Abiomed Breethe OXY-1 System Clinical Trial Artificial Intelligence Algorithm Artificial Intelligence Algorithm Product Overview Expandable Sheath - Heart Failure Expandable Sheath - Heart Failure Product Overview Impecmo Impecmo Product Overview Impella BTR Impella BTR Product Overview Impella BTR Clinical Trial Impella ECP Impella ECP Product Overview Impella ECP Clinical Trial Impella RP Flex with SmartAssist Impella RP Flex with SmartAssist Product Overview Impella XC Impella XC Product Overview Impella XR Sheath With Impella CP Impella XR Sheath With Impella CP Product Overview Next Generation Impella CP - STEMI Next Generation Impella CP - STEMI Product Overview Next Generation Impella CP - STEMI Clinical Trial Symphony Heart Pump Symphony Heart Pump Product Overview Abiomed Inc Abiomed Inc - Key Competitors Abiomed Inc - Key Employees Abiomed Inc - Key Employee Biographies Abiomed Inc - Locations And Subsidiaries Head Office Other Locations & Subsidiaries Recent Developments Abiomed Inc, Recent Developments Oct 23, 2023: Abiomed to Highlight Data Analysis Identifying Complex Clinical Profile of Patients Receiving Impella-Supported HRPCI at TCT Symposium Aug 17, 2023: Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots Jul 27, 2023: Abiomed Recalls Nearly 8,000 Devices From Impella Pump Range Jul 11, 2023: Abiomed Receives 510(k) Clearance for preCARDIA Occlusion System Jun 14, 2023: Class 1 Device Recall Impella 2.5 Jun 05, 2023: Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support May 18, 2023: Analysis Showcases Potential for More Complete Revascularizations with Impella Compared to IABP During HRPCI Apr 25, 2023: Pivotal Impella ECP study expands enrollment to three New Jersey hospitals Mar 13, 2023: Breethe receives additional 510(k) clearance for Abiomed Breethe OXY-1 System Feb 21, 2023: Breethe Announces Meditation & Stress App Provides Free Memberships to Those Who Have Been Laid Off Company Coverage Boston Scientific LivaNova Plc Edwards Lifesciences Medtronic Teleflex Abbott Laboratories Getinge Terumo For more information about this company profile visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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Interim analysis estimated to occur in late Q2 2024 and will be based on at least 50% of anticipated primary outcomesPivotal Phase 3 trial continues to progress with over 75% of initially-planned patients enrolled European Patent Office notice allows for expansion of FDY-5301 patent protection into the EU SEATTLE, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Faraday Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage in acute ST-elevation myocardial infarction (STEMI) through the treatment of reperfusion injury, today announced its agreement with the Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) amendment, enabling the company to expedite its planned Phase 3 study interim analysis. The company also announced its receipt of a notice of “intention to grant” its FDY-5301 patent application from the European Patent Office (EPO), allowing for the expansion of FDY-5301’s protection across the European Union (EU) into 2035. The SPA amendment optimizes the timing, based on the study’s current enrollment rate, and expands the data set of the interim analysis. The interim analysis covers at least 50% of the study’s anticipated primary outcomes and enables the company to potentially upsize the study’s enrollment to increase the likelihood of meeting its primary endpoints. In addition, once Faraday’s European patent application (no. 15746855.4, entitled Halogen Treatment of Heart Attack and Ischemic Injury) is officially granted and validated, the company will have achieved its goal of securing FDY-5301 patent protection in major markets worldwide. “We are grateful for the FDA’s continued support and guidance and pleased to have its written agreement on our expedited interim analysis for the pivotal Phase 3 trial of FDY-5301,” said Dr. Stephen A. Hill, Chief Executive Officer of Faraday. “The interim analysis is now expected four to six months sooner than previously planned, and if our data monitoring committee recommends upsizing the study, we will gain a meaningful range of statistically supported probabilities of success by doing so.” Dr. Hill continued: “In addition, the European patent grant will enhance the commercial potential of FDY-5301. We look forward to completing our Phase 3 study enrollment and potentially bringing FDY-5301 forward as the first therapy for reducing post-STEMI ischemia-reperfusion injury.” The ongoing Phase 3 IOCYTE AMI-3 study is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of FDY-5301 in reducing cardiovascular (CV) death and heart failure events in anterior STEMI patients undergoing primary percutaneous intervention (PCI). Unless upsized based on the interim analysis, the study plans to enroll approximately 2,300 anterior STEMI patients across 150 centers in North America, Europe, and Israel. The trial is being conducted under a Special Protocol Agreement reached with the U.S. Food and Drug Administration. For more information on the IOCYTE AMI-3 Phase 3 please visit ClinicalTrials.gov and reference Identifier NCT04837001. About STEMI Acute STEMI is a leading cause of cardiovascular death and remains a primary cause of the development of heart failure. Standard treatment of a STEMI involves PCI, during which a catheter is inserted into the artery to remove the blockage and restore blood flow. Following a STEMI episode, one of the critical factors influencing patient outcome is reperfusion injury which occurs when the oxygen-rich blood supply returns to the ischemic area. About FDY-5301FDY-5301 is an elemental reducing agent containing sodium iodide for which Faraday has obtained method of use patent protection in major markets worldwide. FDY-5301’s unique properties are well-suited to mitigate ischemia-reperfusion injury (IRI). In preclinical IRI models, FDY-5301 reduced tissue damage, infarct size, and inflammation. FDY-5301 functions as a catalytic neutralizer of hydrogen peroxide, a prominent reactive oxygen species implicated in the IRI cascade leading to cardiomyocyte death, and also acts as an immunomodulating agent. A Phase 2 clinical trial of FDY-5301 in treating IRI following a STEMI demonstrated the treatment was well-tolerated and provided encouraging signals of potential efficacy in minimizing cardiac damage. Results from that trial — known as IOCYTE AMI — were reported in the January 15, 2022, issue of the International Journal of Cardiology. About Faraday Pharmaceuticals, Inc.Faraday Pharmaceuticals® is a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage in acute STEMI. The company was founded by Dr. Mark Roth of the Fred Hutch Cancer Center and is backed by an investor group led by ARCH Venture Partners and Polaris Partners. The company’s lead program, FDY-5301, is in a pivotal Phase 3 trial and is designed to reduce ischemia-reperfusion injury in acute STEMI, a leading cause of death and a primary cause of the development of heart failure. The company is headquartered in Seattle. For more information, visit www.faradaypharma.com or follow the company on LinkedIn. Contact:Brian BlackmanChief Financial Officerbblackman@faradaypharma.com PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com

In cardiology, every minute counts when it comes to receiving, analyzing, and acutely diagnosing patients. Early diagnoses and triage are essential in a cardiology workflow and can save lives. Unfortunately, in an emergency, everything competes for a physician’s time and attention. Artificial intelligence (AI) enables speed and supports cardiologists. By enhancing early detection, helping doctors narrow down possible disease states, and decreasing false activations, AI can change the clinical course of a patient’s treatment for the better. However, many physicians are skeptical of AI. They may believe it will undermine their judgment, independence, and autonomy, and that it foreshadows their replacement. I believe the implementation of AI should not be feared; based on the advantages it confers to physicians, it should actually be welcomed. AI is a tool that can be used in both hospital and clinical settings to promote accuracy, efficiency, and treatment effectiveness. With the integration of AI into an imaging workflow, care can be triaged automatically to ensure the right physicians are notified of and weigh-in on patient data at the right time. Rather than removing the physician from the equation, AI gives clinicians higher quality data and confers on them the ability to generate better insight into disease states. The incorporation of AI into existing cardiology care workflows allows the flagging of critical cases such as heart attack, ST-elevation myocardial infarction (STEMI), and atrial fibrillation (AF). In the United States, between 10,000 and 50,000 heart attacks are missed per year at emergency departments (EDs). The most common cause of inappropriate activation was due to the misinterpretation of electrocardiograms (EKGs) for STEMI criteria often due to the subjective interpretation by ED physicians or emergency medical technicians. Unfortunately, these false activations can have unintended consequences. They can result in physician and staff fatigue, as well as worries that teams don’t take the activations as seriously over time. When this happens, both clinical and financial costs may be incurred. When I treat heart attacks, there can be a long delay between the time the patient gets an EKG to when I can read an EKG accurately on a device. I am not alone. Despite the development of many different systems and software, most hospitals still struggle to get an EKG in a HIPAA compliant manner to a cardiologist to review quickly. National guidelines from the American College of Cardiology and American Heart Association state that hospitals treating STEMI patients with emergency percutaneous coronary intervention (PCI) should reliably achieve a door-to-balloon time of 90 minutes or less. A long delay can push the treatment window past this guideline and may impact patient outcomes. Recently, AI-assisted software has been shown to detect STEMI with a high diagnostic accuracy rate, making it possible to minimize delays in contact-to-treatment times for patients with ST-segment elevation. Like a compass, AI can point the physician in the right direction of care, increasing efficiency and decreasing overall healthcare spend. Similarly, AI gives physicians precise guidance on who needs intervention. For example, when a primary care physician hears a murmur, they might ignore it, or they might order an echocardiogram. As there is no standardization in a primary care doctor’s physical exam assessment, detection is very important at this stage and an EKG read by AI that suggests aortic disease or mitral disease can help predict the need for further testing in an appropriate and efficient manner. Alternatively, physicians ordering unnecessary tests waste both time and money for patients and the health care system. As a cardiologist, if I order a cardiac magnetic resonance imaging (MRI), it can take weeks after the study is complete to get the report back. Comparatively, AI analysis of cardiac MRI data may also be used to expedite the evaluation to minutes once the images are completed. It is clear that AI has the power to expedite care, benefiting patients. For complex clinical cases in which multiple confounding factors are present and multiple diagnoses are under consideration, this may prove to be extremely helpful in saving time. Similarly, AI-based ECG analyses can improve diagnosis and patient management. AI diagnostic performance is already close to that of experienced cardiologists. AI also furthers collaboration and analysis, fully informing discussions about treatment when questions arise. Stroke is one of the most dangerous and life-threatening diseases, but the life of a patient can be saved if the stroke is detected during early stage and a multidisciplinary approach is taken, with various specialists quickly delivering effective care. A multidisciplinary stroke unit team consists of doctors, nurses, physiotherapists, occupational therapists, speech and language therapists, and psychologists and may include input from pharmacists, radiologists, neurologists and geriatric medicine physicians. The simultaneous activation of the appropriate care providers based on AI-backed diagnosis results in faster treatment time, which translates to better outcomes. Additionally, high-resolution images provided by AI-based software can enable physicians to easily obtain input from colleagues and experts in their field, anywhere in the world. Overall, AI is an invaluable tool in hospital and clinical settings promoting diagnostic accuracy, workflow efficiency, and treatment effectiveness. AI gives clinicians the ability to access higher quality data and deliver potentially better insight into disease states. As more data become available and more sophisticated algorithms are developed, AI will play an increasingly important role in the diagnosis and management of cardiac conditions and other diseases. The integration of AI into cardiology workflows can help triage care automatically, ensuring the right physicians weigh in on patient data at the right time which may potentially improve clinical outcomes for all patients in need.