Extracorporeal

Mallinckrodt Presents Data on Real-World Outcomes with THERAKOS™ CELLEX™ Photopheresis System Treatment at the 2024 Tandem Meetings

Retrieved on: 
Wednesday, February 21, 2024
Thermal, Bangladesh Technical Education Board, Pulmonary embolism, Hypotension, Mallinckrodt, Anemia, Month, NIH, PUVA, Meta-analysis, Erythroderma, Excipient, Safety, PUVA therapy, Pain, Infection, Quality of life (healthcare), Deep vein thrombosis, Photopheresis, Artifact, FFS, ECP, Risk, OS, Graft-versus-host disease, Society, Extracorporeal, Methoxsalen, Patient, Systematic review, Burns, Transplant, Massachusetts General Hospital, Sunlight, Literature, Clutch (eggs), Environment, Pharmaceutical industry

DUBLIN, Feb. 21, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation of findings from a systematic literature review and meta-analysis of the safety, efficacy, and real-world outcomes of extracorporeal photopheresis (ECP) treatment for patients with steroid-refractory chronic graft-versus-host disease (SR-cGvHD).1 An analysis of 47 studies reporting on the THERAKOS™ CELLEX™ Photopheresis System showed that treatment of SR-cGvHD with ECP was associated with improvements in patients' overall survival (OS), failure-free survival (FFS), and overall response rate (ORR).1 The results will be shared in a poster presentation at the 2024 Tandem Meetings, the combined Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) taking place February 21-24, 2024 in San Antonio, TX.

Key Points: 
  • Skin-specific response at Months 2-3 and at Months 4-6 were 34.86% (95% CI: 13.26-65.21) and 54.22% (95% CI: 35.67-71.67), respectively.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economics outcomes may not be solely attributable to THERAKOS ECP.
  • THERAKOS™ Photopheresis is contraindicated in:
    THERAKOS™ Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available.
  • Please refer to the THERAKOS™ CELLEX™ Photopheresis System Operator Manual for a complete list of warnings and precautions and adverse events.

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 26, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, Liver, Coronary thrombosis, INN, Risk, Pulmonary embolism, STEMI, ATC, DVT, Unstable angina, Bleeding, International, ASA, Myocardial infarction, Antithrombin, Language, Heart, Stroke, European Medicines Agency, Infection, Extracorporeal, Sodium oxide, Rheumatology, Select, Chest pain, Patient, Aspirin, Vein, Safety, Anatomy, Medicine, Leg, Deep vein thrombosis, IIA, Sodium, Skin, Birth control

Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 26, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Date of authorisation: 15/09/2016, Revision: 26, Status: Authorised

Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve™ Transfemoral System

Retrieved on: 
Tuesday, August 1, 2023
Heart, Communication, Heart failure, Extracorporeal, Chest pain, Genesis, Patient, Aortic valve, Aortic regurgitation, Diagnosis, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, AR, Medtech, Food, Fatigue, Disease, Medical device

BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ -- Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ -- Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
  • J-Valve™ TF System consists of two key components including the J-Valve™ TF Bioprosthesis and the J-Valve™ TF Delivery Device.
  • The J-Valve™ TF System being granted a Breakthrough Device designation underscores the significance of this innovative development for cardiovascular patients.
  • Warren Wang, Chairman & CEO of Genesis MedTech Group shared, "We believe the Breakthrough Device designation for the J-Valve™ TF System is a testament to the innovative spirit and dedication of our team at Genesis MedTech.

Accumen Appoints Esteemed Cardiac Surgeon and Patient Blood Management Leader, Pierre Tibi, MD, to its Medical Advisory Board

Retrieved on: 
Tuesday, March 28, 2023
Society, MSN, Thorax, The Annals of Thoracic Surgery, Cardiothoracic surgery, Dignity Health, MD, Patient, Patient safety, Anemia, Extracorporeal, Patient blood management, RN, Health, Clinical, Medical device, Hospital

Scottsdale, AZ, March 28, 2023 (GLOBE NEWSWIRE) -- Pierre Tibi, MD, has been appointed to the Comprehensive Patient Blood Management (cPBM) Medical Advisory Board at Accumen, where he will provide guidance to its Clinical Transformation Services, MyBloodHealth® program, and support anemia management and overall patient safety initiatives.

Key Points: 
  • Scottsdale, AZ, March 28, 2023 (GLOBE NEWSWIRE) -- Pierre Tibi, MD, has been appointed to the Comprehensive Patient Blood Management (cPBM) Medical Advisory Board at Accumen, where he will provide guidance to its Clinical Transformation Services, MyBloodHealth® program, and support anemia management and overall patient safety initiatives.
  • For more than 10 years, Dr. Tibi has been an internationally and nationally recognized leader in Patient Blood Management.
  • Previously, he served as President of the Society for the Advancement of Patient Blood Management (SABM) and he is now a member of its Board of Directors.
  • “When we educate patients and clinicians alike on anemia and other aspects of Patient Blood Management, we can improve clinical outcomes for our patients.

SeaStar Medical’s Selective Cytopheretic Device to be Featured at the 5th Chronic Kidney Disease Drug Development Summit

Retrieved on: 
Friday, February 24, 2023
Death, Acute respiratory distress syndrome, Safety, White, Chronic kidney disease, System, Department of Defense Serum Repository, Monocyte, Hospice and palliative medicine, Nursing care plan, Research, FDA, Homeostasis, Patient, Organ dysfunction, CKD5, Burns, Pelvic floor dysfunction, SCD, CKD, Neutrophil, Resuscitation, CKRT, COVID-19, Extracorporeal, Pharmaceutical industry, AKI

In his presentation, “The Selective Cytopheretic Device: A Novel Host Response Targeting Cell-Directed Extracorporeal Therapy in AKI (Acute Kidney Disease),” Dr. Chung will discuss the impact of systemic inflammation as a key driver of organ dysfunction and damage in the setting of acute and chronic diseases such as AKI and chronic kidney disease (CKD).

Key Points: 
  • In his presentation, “The Selective Cytopheretic Device: A Novel Host Response Targeting Cell-Directed Extracorporeal Therapy in AKI (Acute Kidney Disease),” Dr. Chung will discuss the impact of systemic inflammation as a key driver of organ dysfunction and damage in the setting of acute and chronic diseases such as AKI and chronic kidney disease (CKD).
  • He will detail the advantages of targeting leukocytes (neutrophils and monocytes) — the main function of the SCD — over targeting downstream byproducts of hyperinflammation.
  • Dr. Chung will also review the clinical data from studies with the SCD in adult and pediatric patients with AKI and COVID-19.
  • The therapy currently is delivered through continuous kidney replacement therapy (CKRT) to target and neutralize pro-inflammatory neutrophils and monocytes allowing the body to return to homeostasis.

Inspira™ Technologies Signs Strategic OEM Agreement with Terumo Cardiovascular

Retrieved on: 
Wednesday, December 28, 2022
Human, Patient, Entrepreneurship, Intubation, Original equipment manufacturer, Originality, ART, Blood, OXY, Annual report, Extracorporeal, OEM, Unitary state, Coma, Risk, Medical device, Pharmaceutical industry

RA'ANANA, Israel, Dec. 28, 2022 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that it has signed an exclusive OEM (Original Equipment Manufacturing) agreement with Terumo Cardiovascular, a division of Terumo Corporation, a leading global medical device company. Terumo Corporation operates in over 160 countries and regions around the world, providing patients in a variety of medical settings with over 50,000 products and services.

Key Points: 
  • Terumo Cardiovascular is a division of Terumo Corporation, a leading medical device company operating in 160+ countries and regions
    RA'ANANA, Israel, Dec. 28, 2022 /PRNewswire/ -- Inspira Technologies OXY B.H.N.
  • Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that it has signed an exclusive OEM (Original Equipment Manufacturing) agreement with Terumo Cardiovascular, a division of Terumo Corporation, a leading global medical device company.
  • Terumo Corporation operates in over 160 countries and regions around the world, providing patients in a variety of medical settings with over 50,000 products and services.
  • Terumo Cardiovascular are experts in the field of oxygenation systems, heart-lung machines and monitoring systems.

Inspira™ Technologies Signs Strategic OEM Agreement with Terumo Cardiovascular

Retrieved on: 
Tuesday, December 27, 2022
Human, Patient, Entrepreneurship, Intubation, Original equipment manufacturer, Originality, ART, Blood, OXY, Annual report, Extracorporeal, OEM, Unitary state, Coma, Risk, Medical device, Pharmaceutical industry

RA'ANANA, Israel, Dec. 27, 2022 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that it has signed an exclusive OEM (Original Equipment Manufacturing) agreement with Terumo Cardiovascular, a division of Terumo Corporation, a leading global medical device company. Terumo Corporation operates in over 160 countries and regions around the world, providing patients in a variety of medical settings with over 50,000 products and services.

Key Points: 
  • Terumo Cardiovascular is a division of Terumo Corporation, a leading medical device company operating in 160+ countries and regions
    RA'ANANA, Israel, Dec. 27, 2022 /PRNewswire/ -- Inspira Technologies OXY B.H.N.
  • Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a groundbreaking respiratory support technology company, announced today that it has signed an exclusive OEM (Original Equipment Manufacturing) agreement with Terumo Cardiovascular, a division of Terumo Corporation, a leading global medical device company.
  • Terumo Corporation operates in over 160 countries and regions around the world, providing patients in a variety of medical settings with over 50,000 products and services.
  • Terumo Cardiovascular are experts in the field of oxygenation systems, heart-lung machines and monitoring systems.

Affluent Medical : Pivotal study progresses to 24 patients successfully implanted with KaliosTM, an adjustable mitral ring that avoids complex re-interventions.

Retrieved on: 
Friday, October 28, 2022
Company, Regulatory News Service, Associate, Medical school, Safety, Congress, Minerva, Dispersive flies optimisation, Department, ISIN, NYHA, Urinary incontinence, Patient, Regurgitation, Surgeon, Degenerative disease, Association, Adrenal insufficiency, Extracorporeal, Heart, Mortality, Optimization, Birth control, Pharmaceutical industry, Medical device, Dentistry, Hospital, Medtech

Affluent Medical : Pivotal study progresses to 24 patients successfully implanted with KaliosTM, an adjustable mitral ring that avoids complex re-interventions.

Key Points: 
  • Affluent Medical : Pivotal study progresses to 24 patients successfully implanted with KaliosTM, an adjustable mitral ring that avoids complex re-interventions.
  • Pivotal study progresses to 24 patients successfully implanted with KaliosTM, an adjustable mitral ring
    Excellent results continue to confirm the efficacy of the KaliosTM adjustable mitral ring in the Optimise II pivotal study.
  • Sustained interest from the surgical community, for the KaliosTM adjustable mitral ring function performed on 5 patients.
  • After adjustment, the results in terms of reduction of mitral regurgitation were excellent with for these 5 patients, namely trivial mitral regurgitation (grade 1+).

Global Oxygenators Market 2022 - 2027: The Membrane Oxygenators Segment is Expected to Hold the Largest Market Share - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 9, 2022
Medical Devices, Other Health, Hospitals, Health, Managed Care, CAD, Degenerative disease, ICU, Hemolysis, USD, Criticism of the Food and Drug Administration, World Health Organization, Centers for Disease Control and Prevention timeline, FDA, World, Coronary artery disease, Coronary heart disease, susceptibility to, 8, Diabetes, Tissue, Atrial fibrillation, Adoption, Conditional sentence, Critical care, Thrombosis, Moyamoya disease, Obesity, ECMO, Prevalence, Death, Oxygenator, Patient, CABG, WHO, Center, Stroke, COPD, COVID-19, Chronic obstructive pulmonary disease, Extracorporeal, CAGR, Acute respiratory distress syndrome, Cardiovascular disease, Food, Hospital, Pharmaceutical industry, Medical device, Growth

The "Oxygenators Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Oxygenators Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)" report has been added to ResearchAndMarkets.com's offering.
  • The oxygenators market was valued at USD 207 million in 2020, and it is poised to grow at a CAGR of 5.4% during the forecast period.
  • Based on application, the respiratory segment is expected to hold a major market share during the forecast period.
  • This scenario is leading to a higher demand for better treatment with efficient medication, which is driving the market in the United States.

FDA Grants the Hemolung® De Novo Clearance

Retrieved on: 
Monday, November 15, 2021
Health, FDA, Medical Devices, Other Health, General Health, Clinical Trials, Biotechnology, GMP, University, ICU, Carbon dioxide, Hypercapnia, MD, COPD, CO2, CEO, Doctor of Philosophy, Technology, Failure, Food, De novo, ECMO, The Act, ECCO2R, PCO2, COVID, COVID-19, Chronic obstructive pulmonary disease, Multimedia, Emergency Use Authorization, Food and Drug Administration Amendments Act of 2007, Respiratory failure, Mercer University Health Sciences Center, Extracorporeal, Ventilation, Philips, Hospital, Partial pressure, Company, Failure rate, Nursing, EUA, COVID 19, Physician, Louisiana, Patient, Risk, FDA, Dietary supplement, Medical device, Pharmaceutical industry

The Hemolung System is the first and only ECCO2R device cleared by the FDA.

Key Points: 
  • The Hemolung System is the first and only ECCO2R device cleared by the FDA.
  • In order to demonstrate benefit over risk, ALung submitted data to FDA from over 1,000 Hemolung patient treatments on clinical safety and over 230 Hemolung patient treatments on clinical performance outcomes.
  • This clinical data along with all of our pre-clinical data demonstrated to the FDA that the clinical benefits of the Hemolung for ECCO2R therapy has been substantiated.
  • For more information on the use of the Hemolung RAS for COVID-19 patients, please visit www.alung.com/covid-19
    *The Hemolung RAS has been authorized for the above emergency use by FDA under an EUA.