Fontan procedure

CHOP Researchers Discover Underlying Biology Behind Fontan-Associated Liver Disease

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수요일, 4월 24, 2024
Online, Science Publishing Group, Fontan procedure, Patient, Cell, Hepatocyte, Liver disease, Inferior vena cava, Science Translational Medicine, Hope, NIH, Hospital, Blood, Tissue, Robert, CHOP, Agent handling, Heart, Wellness, MD, RNA, Medical laboratory, Doctor of Philosophy, SVRF, Activity, Survivor, Disease, Pathology, Ventricular septal defect, Fibrosis, Stasi, FC, Assistant, Biology, Children's Hospital of Philadelphia, Quality of life, Scar, Defense, Pharmaceutical industry

PHILADELPHIA, April 24, 2024 /PRNewswire/ -- As patients with congenital heart diseases live longer, researchers are attempting to understand some of the other complications they may face as they age. In a new study, a team from Children's Hospital of Philadelphia (CHOP) used state-of-the-art technologies to understand the underlying biology of Fontan-associated liver disease (FALD).

Key Points: 
  • In a new study, a team from Children's Hospital of Philadelphia (CHOP) used state-of-the-art technologies to understand the underlying biology of Fontan-associated liver disease (FALD).
  • The Fontan operation is the current standard of care for single-ventricle congenital heart disease.
  • As more patients undergo the Fontan surgery for single-ventricle congenital heart disease, FALD has become a more recognized problem.
  • Little information exists on FALD, yet it is distinct from other forms of liver disease, which is why researchers at CHOP wanted to understand the basic biology that could lead to better treatment options and improve these patients' quality of life.

Mezzion Pharma Receives Clear FDA Path Forward for the Approval of Udenafil for Single Ventricle Heart Disease

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화요일, 5월 31, 2022
Protein losing enteropathy, Risk, DCN, VO2, Population, Blood, Private Securities Litigation Reform Act, Cardiology, Survival, Hospital, Adolescence, Exercise, Patient, FDA Special Protocol Assessment, Review, Clinical trial, Adult, Fontan procedure, Marketing, Cardiac output, Vein, FDA, Ventricular septal defect, Artery, Heart, NDA, Therapy, Liver failure, Arrest, Pharmaceutical industry, Medical imaging, Udenafil, Nephrology, Fontan

SEOUL, South Korea and BETHESDA, Md., May 31, 2022 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil for the treatment of single ventricle heart disease (SVHD) in children with Fontan physiology.

Key Points: 
  • SEOUL, South Korea and BETHESDA, Md., May 31, 2022 /PRNewswire/ -- Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil for the treatment of single ventricle heart disease (SVHD) in children with Fontan physiology.
  • More specifically, Mezzion sought clarity on the critical elements of an additional clinical trial that may be needed to complete the NDA submission.
  • The FDA responded to the Meeting Background Package that was submitted by Mezzion to DCN with detailed advice and direction for the path forward for an FDA approval.
  • Mezzion and its wholly owned subsidiary, Mezzion Pharmaceuticals, Inc., have administrative offices in Deerfield, Illinois and Boca Raton, Florida.

The Children's Heart Foundation funds more than $1 million of new congenital heart defect research

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화요일, 12월 28, 2021
Quality of life, Population, Ventricular septal defect, Birth defect, Cardiac arrest, Multimedia, Survival, American Heart Association, Pediatrics, MAS, University of California, San Francisco, University, Research, Congenital heart defect, View, Embry–Riddle Aeronautical University, AHA, Composition of the human body, Pediatrics (journal), CNU, Instagram, CHF, MS, Diagnosis, American Academy, Claire Grady, Doctor of Philosophy, LinkedIn, Twitter, Patient, Longevity, CHD, Fontan procedure, BS, CEO, Pharmaceutical industry, Facebook, Fontan, MD

NORTHBROOK, Ill., Dec. 28, 2021 /PRNewswire/ -- The Children's Heart Foundation (CHF), the nation's leading organization dedicated to funding congenital heart defect (CHD) research, will fund over $1,000,000 of research and scientific collaborations in 2021.

Key Points: 
  • NORTHBROOK, Ill., Dec. 28, 2021 /PRNewswire/ -- The Children's Heart Foundation (CHF), the nation's leading organization dedicated to funding congenital heart defect (CHD) research, will fund over $1,000,000 of research and scientific collaborations in 2021.
  • Every 15 minutes in the United States, a baby is born with a congenital heart defect, making CHDs the nation's most common birth defect.
  • The Children's Heart Foundation's mission is to advance the diagnosis, treatment, and prevention of CHDs by funding the most promising research.
  • This year's funding spans four initiatives: 1. independent research funded by CHF and the Cortney Barnett Research Award, 2. collaborative research with the American Heart Association (AHA) through the AHA/CHF Congenital Heart Defect Research Awards , 3. funding the American Academy of Pediatrics' Pediatric Cardiology Research Fellowship Award , and 4. funding of Cardiac Networks United (CNU) , a national pediatric and congenital cardiovascular research network.

Mezzion Pharma Announces Positive Data Presented to FDA in Type C Meeting

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화요일, 12월 21, 2021
Hospital, Exercise, Review, Liver failure, FDA, Private Securities Litigation Reform Act, Marketing, Ventricular septal defect, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Arrest, Safety, Vein, Therapy, Risk, Male, Cardiac output, Female, Protein losing enteropathy, Blood, FUEL, Survival, Food, Artery, Heart, PHN, Fontan procedure, Patient, Type, Pharmaceutical industry, Fontan, Udenafil

Mezzion Pharma is also pleased to report that the FUEL OLE Trial data supports and is believed to provide independent confirmatory evidence of reproducibility and durability of this efficacy for this very large subgroup.

Key Points: 
  • Mezzion Pharma is also pleased to report that the FUEL OLE Trial data supports and is believed to provide independent confirmatory evidence of reproducibility and durability of this efficacy for this very large subgroup.
  • In view of the positive analysis of the subgroup data from the FUEL Trial and FUEL OLE Trial, Mezzion Pharma continues to look forward to the FDA review process and to bringing a novel pharmacotherapeutic option to this unique Fontan patient population.
  • Mezzion Pharma is a publicly-listed pharmaceutical company in Korea on the Korean stock exchange under (140410:KOSDAQ).
  • Mezzion undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

FDA Approves Two New Indications for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

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화요일, 12월 21, 2021
Advocate Children's Hospital, Warfarin, Rivaroxaban, Adult, Thrombosis, Learning, BCPA, FDA, Child, Caregiver, Physician, DOAC, Fortis Healthcare, Mended Hearts, Ventricular septal defect, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Standard of care, Infection, Thrombus, Injection, Risk, Tablet, Hospital, Program, Janssen Pharmaceuticals, Parent, Food, Anticoagulant, VTE, MS, Fontan procedure, Ageing, Patient, Johnson & Johnson, Birth control, Pharmaceutical industry, Fontan

RARITAN, N.J., Dec. 20, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure. XARELTO® is the only direct oral anticoagulant (DOAC) FDA-approved for primary prevention of clots in pediatric patients following the Fontan procedure and the only DOAC in the U.S. to offer an oral suspension formulation for flexible, body weight-adjusted dosing options for pediatric patients.

Key Points: 
  • XARELTO is used in children to:
    treat blood clots or reduce the risk of blood clots from happening again in children from birth to less than 18 years, after receiving initial treatment with injectable or intravenous medicines used to treat blood clots.
  • help prevent blood clots in children 2 years and older with congenital heart disease after the Fontan procedure.
  • XARELTO may cause serious side effects, including:
    Increased risk of blood clots if you stop taking XARELTO.
  • If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.