Anterior Wall Myocardial Infarction

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death Abiomed recalls the instructions for use for Impella left sided blood pumps due to perforation risks. (Credit: Robina Weermeijer on Unsplash) Recalled Product US Available Product Names: Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist ; Impella LD Distribution Dates: October 10, 2021 to October 10, 2023 Devices Recalled in the U.S.: 66,390 Date Initiated by Firm: December 27, 2023 Device Use Impella Left Sided Blood Pumps are used for short term support of the pumping chambers of the heart (ventricles) during high-risk catheter-based procedures called percutaneous coronary interventions (PCI). Impella Left Sided Blood Pumps also are used when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy. Impella therapy aims to reduce the work of the heart’s ventricles and provide support for the circulatory system so the heart has time to recover. There are several types of Impella pumps that are used for different therapeutic reasons. Reason for Recall Abiomed is recalling its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. During operations, the Impella device could cut through the wall of the left ventricle. The use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. There have been 129 reported serious injuries, including 49 reports of death. Who May be Affected People who are undergoing procedures with the Impella Left Sided Blood Pumps People who have anterior infarction (heart disease) Elderly people and women What to Do On December 27, 2023, Abiomed sent all affected customers an Urgent Medical Device Correction letter. The letter requested customers to adhere to new and revised warnings: Carefully position the pump catheter during operative procedures Use imaging when advancing or torquing the pump catheter Use special care when inserting the pump catheter in patients with certain high risk conditions or during active CPR Review the updated warnings in the device Instructions for Use Notify everyone at your facility who needs to be informed of this recall correction Notify any other facilities where the products have been forwarded of the updated Instructions for Use Source: Company Press Release

Study Evaluates the Effectiveness of TherOx Supersaturated Oxygen (SSO2) Therapy in Patients Presenting with Acute Anterior Myocardial Infarction with Successful Reperfusion Compared to Standard Therapy CHELMSFORD, Mass.--(BUSINESS WIRE)-- ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the first patient has enrolled in the AMIHOT III post-approval study further evaluating TherOx® SuperSaturated Oxygen (SSO2) Therapy for the treatment of the most severe form of heart attack, left anterior descending (LAD) ST-Elevation Myocardial Infarction (STEMI). The patient, treated at WakeMed Health & Hospitals in North Carolina, received SSO2 Therapy, the first FDA-approved therapy shown to significantly reduce the size of damaged tissue (infarct) following percutaneous coronary intervention (PCI). This press release features multimedia. View the full release here: ZOLL’s TherOx® SSO2 System delivers SSO2 therapy immediately post-PCI to reduce infarct size (Photo: Business Wire) Multiple clinical trials have demonstrated the efficacy of SSO2 Therapy in reducing infarct size in LAD STEMI1,2,3 by delivering a high concentration of dissolved oxygen (7–10x normal) directly to damaged heart muscle immediately after stenting. TherOx SSO2 Therapy is currently indicated for patients who suffer LAD STEMI — heart attacks with a high mortality rate — treated within six hours of symptom onset. SSO2 Therapy has been shown to reduce relative infarct size — damage to the heart muscle — by 26% over standard of care. One year follow-up data on patients treated with SSO2 Therapy showed reductions in heart failure hospitalization and mortality.4 AMIHOT III is a randomized, post-approval evaluation that will further validate the benefits of SSO2 Therapy over current standard of care alone and provide insight into the mechanisms that lead to improved outcomes for LAD STEMI patients. Besides demonstrating the safety and effectiveness of SSO2 Therapy, additional endpoints include incidence of microvascular obstruction (MVO), and outcomes measures such as heart failure readmissions and quality-of-life measures. The study will randomize 434 patients across sites in the U.S. and Europe. The study’s Principal Investigator is James Blankenship, MD, MHCM, MSCAI (University of New Mexico, Albuquerque, NM). “WakeMed strives to be on the cutting edge of cardiovascular care, and I am excited that our team has enrolled the first AMIHOT III patient in this study to further confirm SSO2 Therapy’s benefits over standard of care in the treatment of severe heart attacks,” said Frances Wood, MD, interventional cardiologist at WakeMed. “Based on our experience with the IC-HOT trial that helped SSO2 achieve FDA approval, we believe this therapy will have a strong impact in improving outcomes and reducing mortality for heart attack patients.”5 “With SSO2 Therapy, ZOLL is expanding care for LAD STEMI patients,” added Christopher Barnabas, President of ZOLL Circulation. “Previous data serve as a strong indication that we will observe short- and long-term outcome improvements such as reduced incidence of heart failure and mortality in these high-risk patients.” 1,2,3,4 About ZOLL ZOLL, an Asahi Kasei company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. For more information, visit . About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit . Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit . About WakeMed Health & Hospitals Serving the community since 1961, WakeMed is a not-for-profit health care system founded and based in Raleigh, N.C. WakeMed exists to improve the health and well-being of our community by providing outstanding and compassionate care to all. WakeMed’s 970-bed system comprises a network of facilities throughout the Triangle area, including three full-service hospitals, seven emergency departments, a dedicated Children’s Hospital and Rehabilitation Hospital, more than 80 physician offices and Wake County’s only Level I and Level III Trauma Centers. WakeMed’s mission-driven team includes more than 10,300 employees, 1,000 volunteers and 1,300 affiliated physicians, along with the more than 700 physicians and providers with WakeMed Physician Practices – all representing the best minds and the biggest hearts and the finest quality in health care and community health. For more information, visit or follow WakeMed on Facebook, Twitter and Instagram. ______________ 1 Stone GW, et al. Circ Cardiovasc Intervent 2009;2:366-75 2 O’Neill WW, et al. Jour of Am Coll Cardiol. 2007;50: 5:397-405. 3 David SW, et al. Catheter Cardiovasc Interv. 2018;1–9. 4 Chen, et al. Catheter Cardiovasc Interv. 2020;1–7. 5 David SW, et al. Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study. Catheter Cardiovasc Interv. 2018;1–9. Copyright © 2022 ZOLL Medical Corporation. All rights reserved. TherOx and ZOLL are trademarks or registered trademarks of ZOLL Medical Corporation and/or its subsidiaries in the United States and/or other countries. Asahi Kasei is a registered trademark of Asahi Kasei Corporation. All other trademarks are the property of their respective owners.

Faraday Pharmaceuticals Inc., a muscle health-focused biopharmaceutical company developing therapeutics to treat patients experiencing potentially life changing critical illness, announced today the publication of results from its Phase 2 trial of FDY-5301 for the treatment of reperfusion injury following an ST-elevation myocardial infarction (STEMI) in the January 15, 2022 issue of the International Journal of Cardiology. Data from the study – known as Iocyte AMI – demonstrated the treatment was well-tolerated and provided encouraging signals of potential efficacy in minimizing cardiac damage. In the study, 120 patients were randomized to receive placebo or FDY-5301 (0.5mg/kg, 1.0 mg/kg or 2.0 mg/kg), administered intravenously as a single-dose treatment prior to reperfusion therapy with primary percutaneous coronary intervention (pPCI) for acute STEMI. Outcome measures included 14-day arrhythmia monitoring and magnetic resonance imaging (MRI) of infarct size and cardiac function at three months post-treatment. Results show that treatment with FDY-5301 was well-tolerated, with no evidence of increased risk of clinically significant arrhythmias at doses up to 2 mg/kg. In addition, encouraging signs of efficacy were observed. Median infarct size (as a proportion of left ventricular volume) in the 2mg/kg FDY-5301 group was 8.5% compared to 14.9% on placebo. Median left ventricular ejection fraction was 53.9% for patients on placebo compared to 63.2% for patients on 2mg/kg FDY-5301. The study was not powered for these secondary efficacy outcomes, so these improvements did not reach statistical significance. “It has long been shown that the size of an AMI is not only determined by ischemic damage, but also by the reperfusion itself," said Dr. Stephen Hill, Faraday's Chief Executive Officer. “We were very excited to see data suggesting that FDY-5301 may act to reduce this damage.” Based on this data, Faraday plans to start enrollment in the first half of 2022 into a randomized, double-blind, placebo-controlled Phase 3 study of intravenous FDY-5301 in patients with an anterior STEMI. The study is powered to show a 30% relative reduction in cardiovascular (CV) death and heart failure with a two-sided p-value of less than 0.05, which, if successful, would support a regulatory submission for marketing approval in the United States. Demonstrating a 30% relative reduction in CV death and heart failure in anterior STEMIs could form the basis of a generalizable label for all STEMI patients undergoing pPCI. Professor Keith Channon, Director of R&D for Oxford University Hospitals and a principal investigator for the both the Phase 2 and Phase 3 studies, commented that, “In addition to being easily administered without interrupting the flow of time critical activities needed in the emergency setting of an acute myocardial infarction, FDY-5301 showed potentially encouraging signs of efficacy in reducing infarct size that merit proceeding into a Phase 3 study looking at clinical outcomes.” About STEMI and Reperfusion Injury An estimated 810,000 Americans will suffer a heart attack in 2021. A STEMI is a heart attack that occurs when a coronary artery is blocked, stopping blood flow to an area of the heart. This area becomes ischemic due to lack of oxygen and requires immediate treatment to minimize the amount of damage caused. Standard treatment of STEMI involves pPCI, during which a catheter is inserted into the artery to remove the blockage and restore blood flow. Reperfusion injury is the damage done when the oxygen-rich blood supply returns to the ischemic area. This damage contributes a significant portion of the total cardiac muscle damage suffered as a result of a heart attack. About FDY-5301 FDY-5301 is an elemental reducing agent containing sodium iodide for which Faraday has obtained method of use patent protection in major markets worldwide. It works to catalytically destroy hydrogen peroxide, which is generated as a response to acute injury and contributes to loss of muscle mass and function. Preclinical studies of FDY-5301 have demonstrated its ability to reduce cardiac and skeletal muscle injury. About Faraday Faraday Pharmaceuticals® is a Seattle-based biopharmaceutical company founded by Dr. Mark Roth of the Fred Hutchinson Cancer Research Center and backed by an investor group led by ARCH Venture Partners and Polaris Partners. With a clinically and commercially experienced senior leadership team, the company is focused on treating and preventing muscle injury.