Acute myocardial infarction

PATHFAST hs-cTnI-II becomes first and only hs-cTn test cleared for point-of-care use in the United States, delivering results up to three times faster than core lab testing CORTLANDT MANOR, N.Y., March 27, 2024 /PRNewswire/ -- The PATHFAST hs-cTnI-II, a breakthrough high-sensitivity troponin assay developed for the PATHFAST Biomarker Analyzer, received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new test will facilitate the accurate, rapid diagnosis of myocardial infarction at the point of care. The PATHFAST point-of-care platform offers a comprehensive menu of tests that bring central lab-quality diagnostic results closer to the clinician and patient, saving valuable time when evaluating patients with potentially life-threatening conditions. Continue Reading Chest pain remains the second most common reason for adults to seek care at the emergency department (ED) in the United States, accounting for over 7 million annual visits.1 Timing of troponin test results is a critical factor in helping doctors quickly diagnose and effectively treat patients. When patients enter the ED with a suspected heart attack, doctors typically use a troponin blood test to aid in their diagnosis. Before the introduction of the PATHFAST high-sensitivity troponin assay, the test was only available in the hospital central laboratory where results typically can take an hour or more to get to the physician. The PATHFAST platform delivers results in 17 minutes at the point of care,2 providing EDs and other acute care facilities the ability to make accurate diagnostic and treatment decisions much faster than previously available. PATHFAST hs-cTnI-II becomes first and only hs-cTn test cleared for point-of-care use in the United States. Post this "Both speed and quality in high-sensitivity cardiac troponin testing are essential in the emergency department for safe and timely disposition of patients. Access to rapid and accurate results can assist clinicians in identifying patients through safe, early rule-out protocols that can decrease length of stay, reduce overcrowding, and improve patient satisfaction, all while assuring that patients with abnormal findings suggestive of acute coronary syndromes and myocardial infarction receive appropriate care," said Robert H. Christenson, Ph.D., DABCC, FADLM, FACC. "Polymedco is committed to providing the most accurate and efficient diagnostics to help overburdened Emergency Departments more effectively and efficiently respond and treat patients presenting with symptoms of a heart attack. Having the diagnostic accuracy of high-sensitivity cardiac troponin at the point-of-care represents a significant advancement in cardiac care in the U.S.," said Polymedco CEO Doug White. With this clearance, the test may be sold in the U.S. for use on Polymedco's PATHFAST analyzer with whole blood and plasma patient specimens. PATHFAST High Sensitivity Troponin-I results should be used in conjunction with other diagnostic information such as electrocardiogram (ECG), clinical findings and patient symptoms to aid in the diagnosis of heart attacks. About the PATHFAST Biomarker Analyzer PATHFAST facilitates critical care decisions through a comprehensive menu of lab tests used for patients with possible acute myocardial infarction, congestive heart failure, deep vein thrombosis, pulmonary embolism, and inflammatory conditions by providing lab-quality results in minutes at the point of care. Flexibility to run up to 6 tests at once from a small volume of whole blood or plasma Space-saving design ideal for the Emergency Department, STAT lab, or Urgent Care Center Easy, user-friendly operation About Polymedco Polymedco partners with healthcare systems, payors, providers, and reference labs to develop best-in-class screening and early detection programs that can help identify life-threatening diseases earlier. We're proud to offer a portfolio of products with exceptional performance, robust clinical evidence, and user-friendly design. Connect with Polymedco at , on LinkedIn at , or on Facebook at For more information: Polymedco Communications: Anthony Bercaw [email protected] References: 1. Kontos M, de Lemos, J. et al. 2022 ACC Expert consensus decision pathway on the evaluation and disposition of acute chest pain in the emergency department: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022;80(20):1925-1960. doi:10.1016/j.jacc.2022.08.750 2. Point of care cardiac troponin I and T assay analytical characteristics. IFCC Committee on Clinical Applications of Cardiac Bio-Markers. Accessed March 13, 2024. SOURCE Polymedco, LLC

PITTSBURGH, March 27, 2024 /PRNewswire/ -- At a meeting with the investment community today, Viatris Inc. (NASDAQ: VTRS), a global healthcare company, will outline how it is continuing to evolve its R&D strategy to deliver on its goal of building a more durable, higher-margin portfolio of patented innovation on the foundation of its strong base business. The focus of the event will be a discussion of its collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod and key elements of the Company's pipeline. Viatris CEO Scott A. Smith said: "Our confidence in our ability to continue to drive future growth and unlock shareholder value comes from our strong base business, well-established global infrastructure, and significant financial flexibility all of which give us the opportunity to continue to evolve our pipeline with the addition of potential blockbuster assets like selatogrel and cenerimod. The addition of high-science programs that deliver novel, meaningful patient impact and address significant unmet patient need will also give us the opportunity to accelerate long-term growth." Event highlights will include: Overview of global collaboration with Idorsia. The collaboration with Idorsia is a great example of Viatris' strategy in action—adding two late-stage potential blockbuster assets, selatogrel and cenerimod—and connecting Idorsia's highly productive drug development team and innovation engine with Viatris' existing infrastructure and experience. The Company will review key elements of the collaboration including how Viatris can make a difference in the delivery of these assets. The Company's history of development success. Viatris' confidence is rooted in the strength of its base business, its deep in-house development capabilities, the diversity of its pipeline and its proven track record of scientific success, including a remarkable list of firsts that have enabled the Company to address some of the world's most enduring health challenges. The Company will review key highlights from its high-margin organic pipeline, which it expects will deliver $450 million to $550 million in revenue in 2024. Overview of selatogrel. Selatogrel, a potentially life-saving medicine, aims to become the first and only self-administered treatment for Acute Myocardial Infarction (AMI), or heart attack, by filling the medical gap between the onset of symptoms and hospitalization when early intervention is critical. The Company will review the pharmacological pro selatogrel and the currently enrolling Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI) global Phase 3 multi-center trial. This cardiovascular outcomes-based trial has received Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and selatogrel has received Fast-Track designation from the FDA. Overview of cenerimod. Cenerimod's novel mechanism of action has the potential to be a differentiated therapy for the treatment of Systemic Lupus Erythematosus (SLE), a chronic and progressive autoimmune disease in constant need of new treatment options that are safe and tolerable. The Company will review key learnings from the comprehensive Phase 2 program that has already been conducted and will review Oral S1P1 Receptor ModUlation in SLE (OPUS), the two ongoing Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate cenerimod's efficacy, safety and tolerability in adult patients with moderate-to-severe SLE in addition to standard background therapy. Cenerimod has also received Fast-Track designation from the FDA. 2024 R&D Event Presenters The event will feature presentations from the following Viatris executives: Scott A. Smith, Chief Executive Officer Rajiv Malik, President Philippe Martin, Chief R&D Officer Doretta Mistras, Chief Financial Officer Expert thought leaders presenting at the event are: Dr. Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI, a top expert in cardiovascular medicine and interventional cardiology, is the Director of Mount Sinai Fuster Heart Hospital. Dr. Bhatt is highly recognized for his significant breakthroughs in the field of cardiology, including interventional cardiology, heart disease prevention, vascular medicine and heart failure. Dr. Anca Askanase, MD, founder and clinical director of Columbia University's new Lupus Center and the Director of Rheumatology Clinical Trials. Dr. Askanase is an internationally renowned clinician, diagnostician and researcher with more than 15 years specializing in complex SLE. Dr. Askanase trained as a rheumatologist at New York University (NYU) where she remained for more than 15 years on faculty, directing clinical trials, training fellows and residents and treating challenging cases of SLE at NYU's prestigious hospitals. Webcast Details Interested parties will be able to access a live webcast of the event at investor.viatris.com. An archived version also will be available following the live event and can be accessed at the same location for a limited time. About selatogrel Selatogrel is a potent, fast-acting, reversible and highly selective P2Y12 inhibitor, being developed for the treatment of Acute Myocardial Infarction (AMI), in patients with a history of AMI. It is intended to be self-administered subcutaneously via a drug delivery system (autoinjector). This novel, self-administered emergency agent has the potential to protect heart muscle in the very early phase of an AMI – in the crucial time between symptom onset and first medical attention – so as to treat the ongoing AMI and prevent early death. Viatris is enrolling patients into a large international, double-blind, randomized, placebo-controlled Phase 3 study – Selatogrel Outcome Study in suspected Acute Myocardial Infarction (SOS-AMI) – to assess the clinical efficacy and safety of selatogrel 16 mg when self-administered (on top of standard of care) upon the occurrence of symptoms suggestive of AMI. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI, after self-administration of the study treatment. A Special Protocol Assessment has been agreed with the FDA, indicating its concurrence with the adequacy and acceptability of critical elements of overall protocol design for a study intended to support a future marketing application. Selatogrel has received Fast-Track designation from the FDA. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need. About cenerimod Cenerimod is a highly-selective S1P1 receptor modulator given as an oral once-daily tablet. Cenerimod potentially offers a novel approach for the treatment of SLE, a disease with a significant impact on patients and limited treatment options. In December 2022, the Oral S1P1 receptor ModUlation in SLE (OPUS) program was initiated, which consists of two multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies to evaluate the efficacy, safety and tolerability of cenerimod in adult patients with moderate-to-severe SLE on top of background therapy. The main objectives of the program are to evaluate the effectiveness of cenerimod 4 mg in reducing disease activity, as well as controlling the disease, compared to placebo. The primary endpoint is response on SRI-4 at month 12 compared to baseline. Secondary endpoints include response on BICLA at month 12 compared to baseline and – for the first time in a lupus registration study – measures of sustained disease control: time to first confirmed 4-month sustained mSLEDAI-2K response and time to first confirmed 4-month sustained response in mucocutaneous manifestations (i.e. rash, alopecia, mucosal ulcers). The investigation of cenerimod for the treatment of SLE has received Fast-Track designation from the FDA. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need. About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements regarding how it is continuing to evolve its R&D strategy to deliver on its goal of building a more durable, higher margin portfolio of patented innovation on the foundation of its strong base business; its collaboration with Idorsia, Phase 3 assets selatogrel and cenerimod and key elements of the Company's pipeline; our confidence in our ability to continue to drive future growth and unlock shareholder value comes from our strong base business, well-established global infrastructure, and significant financial flexibility all of which give us the opportunity to continue to evolve our pipeline with the addition of potential blockbuster assets like selatogrel and cenerimod; the addition of high-science programs that deliver novel, meaningful patient impact and address significant unmet patient need will also give us the opportunity to accelerate long-term growth; the collaboration with Idorsia is a great example of Viatris' strategy in action—adding two late-stage potential blockbuster assets, selatogrel and cenerimod—and connecting Idorsia's highly productive drug development team and innovation engine with Viatris' existing infrastructure and experience; the Company's high-margin organic pipeline, which it expects will deliver $450 million to $550 million in revenue in 2024; information about selatogrel and cenerimod, information about clinical trials and studies; that a special protocol assessment has been agreed with the FDA, indicating its concurrence with the adequacy and acceptability of critical elements of overall protocol design for a study intended to support a future marketing application; selatogrel has received fast-track designation from the FDA; the investigation of cenerimod for the treatment of SLE has received fast-track designation from the FDA. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the outcome of clinical trials and studies; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; the possibility that Viatris may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that Viatris may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, other transactions or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets; Viatris' failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. Company Codes: NASDAQ-NMS:VTRS

3月21日，强生医疗 (Johnson & Johnson MedTech) 的 Abiomed 部门再次发生严重召回事件，FDA 已将其确定为 I 级召回，即最严重的召回类型，表明使用这些设备可能会导致严重伤害或死亡。涉及到微型 Impella 心脏泵系列产品，此前有报道称该设备在操作过程中可能会刺穿和切穿左心室壁。01已致129人重伤，其中49人死亡FDA本周报告称，在 129 份重伤记录中，有 49 名患者因该问题死亡。 强生 (J&J) 的 Abiomed 此前于 12 月底向医疗保健提供者发出了一封紧急医疗设备更正函，通知医疗保健提供者存在风险，此次召回涉及 Impella 泵各类型号中的 66,390 台设备。FDA 于 3 月 20 日向该企业发起一级召回，这是该机构最严重的召回指定，但是，没有任何设备部件被认为有缺陷，也不需要退回给制造商。  Impella装置示意图Impella 左侧血泵用于在称为经皮冠状动脉介入治疗 (PCI) 的高风险导管手术期间为心脏（心室）的泵室提供短期支持。当严重心脏病发作（急性心肌梗塞）、心脏直视手术后 48 小时内发生持续心源性休克，或者由于心肌病导致心脏功能不良时，也可使用 Impella 左侧血泵。Impella 疗法旨在减少心室的工作并为循环系统提供支持，以便心脏有时间恢复。Impella 泵有多种类型，用于不同的治疗目的。召回原因Abiomed 正在召回其 Impella 左侧血泵，在手术过程中，Impella 装置泵导管可能会刺穿（切割）心脏左心室壁。使用受影响的 Impella 泵可能会导致严重的不良健康后果，包括左心室穿孔或游离壁破裂、高血压、血流不足和死亡。 相反，根据 FDA 的召回公告，该公司和该机构已更新了设备使用说明（IFU）中对外科医生的警告，以强调“由于操作员操作”而存在穿孔的潜在风险。解决方案强生医疗在给媒体的一份声明中表示：“出于对患者安全的考虑，我们的 IFU 已更新，提供了有关植入和重新定位的更强有力的技术指导，并强调植入 Impella 时要考虑特定的心脏和外周血管解剖学因素。” “此通知并非设备移除，Impella 心脏泵仍留在市场上并可供患者使用。”此外，FDA 敦促用户在推进或扭转泵导管时采用成像辅助系统，并表示具有特定风险的人可能包括女性、老年人和既往有过前壁梗死史的人，或者在接受手术后最靠近胸部前部的疤痕心脏组织的人群要特别注意。该机构还表示，在对植入患者进行心肺复苏胸部按压时应尤为小心。侵入性较小的泵通过血管蜿蜒进入心室，内部装有旋转叶轮，可将血液压入主动脉，从而减轻衰弱的心肌的部分工作量。02曾被两次一级召回△Impella®系列心脏泵2023年7月，Impella又一次被美国药监局一级召回。原因是：对于实施过经导管主动脉置换手术（TAVR）的患者，Impella的旋转叶轮存在与TAVR植入物（远端支架）碰撞的风险，碰撞可能损坏或毁坏叶轮叶片。受损的叶轮系统可能减少血流量或停止心脏泵的运行，从而延误治疗或无法为患者提供足够的血流量支持。对于需要高水平支持的患者而言，没有足够的血流量支持，可能会危及生命。另一风险是破碎的叶片碎片可能流入血管系统，引发栓塞。该公司敦促外科医生在调整其在心脏内的位置之前确保该装置已停止。FDA随后报告了与该问题相关的四例死亡事件。2023年6月，FDA曾对Impella 5.5发起过另一级召回涉及466台设备，该款产品是右侧泵（带有 SmartAssist 的 Impella RP Flex），召回原因是灌注液泄漏导致灌注压降低，引起设备警报。此前更新说明澄清了患者的抗凝凝血时间低于建议的情况。这些患者可能面临血栓形成或颗粒沉积物堆积的风险；FDA 报告了与此次召回相关的 12 起受伤事件。2022年12月22日，全球医疗巨头强生公司宣布已完成对Abiomed，Inc.的收购，总收购金额约166亿美元。Abiomed成立于1981年，总部位于美国马萨诸塞州，是提供循环支持和充氧的医疗设备的领先提供商，也是全球心室辅助血泵（VAD）领域佼佼者，其生产的Impella心脏泵，是唯一获得美国 FDA 批准适用于需要高危 PCI 或 AMI 心源性休克等严重冠状动脉疾病患者的经皮心脏泵技术。目前全球使用Impella心脏泵的患者超过15万。在全球市场，受限于介入式人工心脏的高技术门槛，仅有少数企业布局，而且Impella是目前唯一获得美国FDA批准的经皮心脏泵技术（PVAD），其他企业的介入式人工心脏还处于研发或临床注册阶段。03庞大的患者需求，孕育出下一个大蓝海心衰的危害性及庞大的患者数孕育出了“下一个蓝海”。心力衰竭，五年死亡率高达30-70%，被称为“心血管病领域最后的战场”。根据公开数据，全球心衰患者近3000万，我国心衰患者约有1067万。预计随着心脏疾病患者的生存期延长、老龄化程度加深，心衰患者数量将持续增长。心脏辅助装置（VAD）已逐渐成为治疗终末期心衰的重要手段。市场研究机构ReportLinker发布的数据显示：全球心衰治疗器械市场预计于2025年达到140亿美元；中国心衰管理市场规模将超百亿。国内介入人工心脏崛起介入式人工心脏毫无疑问是高技术、高门槛赛道，但国内仍有一批创新企业布局。其中，永仁心、苏州同心、心擎医疗、航天心泰、心恒睿医疗、核心医疗、通灵仿生、心岭迈德、生命盾医疗、晟视科技、心擎医疗、丰凯医疗等企业积极布局。2024年2月，永仁心医疗推出新一代人工心脏产品EVA-Pulsar™左心室辅助装置正式获得NMPA医疗器械注册证，成为国内第五款上市人工心脏，这标志着永仁心医疗率先完成产品迭代，手握国内唯二两款长期型人工心脏血液泵。其余四款获批产品分别为：永仁心医疗（EVAHEART I）、同心医疗（CH-VAD）、航天泰心（HeartCon）、核心医疗（Corheart6）。尽管心室辅助的长期植入需求巨大，但目前国内外获批长期植入的LVAD寥寥无几。在中国，目前仅有永仁心的EVAHEART 1和EVA-Pulsar™获批长期使用。2022年的商业植入市场份额位居第一，遥遥领先其他同类产品。在美国，仅有一款Heartmate3获批长期使用，其他第三代磁悬浮、磁液悬浮等产品均未获批长期植入。心脏作为生命的动力源泉，其健康状况直接关联到生命的质量。心力衰竭，作为多种心血管疾病的最终表现形态，其患病率、发病率及死亡率均呈逐年上升趋势，已成为当前心血管疾病领域的重大挑战。在人工心脏技术的发展中，介入式人工心脏展现出巨大的应用潜力，有望成为下一阶段的研究热点。展望未来十年，心衰器械领域将迎来发展的黄金时期。我们期待国内医工转化速度能够加快，为心力衰竭治疗带来更多的创新解决方案。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。