Congenital in Medical Technology

CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency

... of acute bleeding episodes in patients with congenital fibrinogen deficiency, the company is entitled to ... of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia ... only company with an FDA approved treatment for congenital fibrinogen deficiency, CSL Behring will work ...

Pediatric Heart Transplants at Montefiore Approved by NY State Department of Health

... America's top children's hospitals, to treat any congenital or acquired heart abnormality in children and ... Bronx suffer from a disproportionate number of congenital heart abnormalities and other serious conditions. ... as among the most active in the region treating congenital and acquired heart defects in children. Key to ...

Treatment Corrects Severe Insulin Imbalance in Animal Studies

... become an innovative medicine for children with congenital hyperinsulinism, a rare but potentially ... for children with the most common type of congenital hyperinsulinism," said study leader Diva D. De ... Hospital of Philadelphia. "This type of congenital hyperinsulinism is caused by mutations in genes ...

Task Force Recommends Screening for Hearing Loss in All Newborns

... -- All newborn infants should be screened for congenital hearing loss that is present at birth, according ... every 1,000 infants born in the United States, congenital hearing loss occurs in between one and three infants. congenital hearing loss happens more frequently than other ...

Edwards Lifesciences Announces First Implants in U.S. Study of Minimally-Invasive Pulmonic Valve

... SAPIEN transcatheter heart valve in addressing a congenital condition in which the valve between the ... to Edwards Lifesciences. "Patients with congenital right ventricular outflow tract problems ... valve platform technologies to help these congenital patients via a minimally-invasive treatment ...

New Guidelines: Antibiotic Prophylaxis

... valve disease -- Calcified aortic stenosis -- congenital heart conditions such as ventricular septal ... -- Unrepaired or incompletely repaired cyanotic congenital heart disease, including those with palliative shunts and conduits -- A completely repaired congenital heart defect with prosthetic material or device, ...

New Research Shows Masimo Perfusion Index (PI) Effective in the Noninvasive Detection of Congenital Heart Defects (CHD) in Newborns

... SET Perfusion Index (PI) to improve detection of congenital heart defects (CHD) in newborns ... in critically-ill newborns to enable its use for congenital heart disease screening purposes. The researchers ... several studies have reported that babies with congenital heart disease are not detected by routine ...

Obesity Common in Children with Heart Disease

... More than 25 percent of children with congenital and acquired heart disease are overweight or ... routines for their children. "Children with congenital heart disease may have unique risk factors which ... samples, 1,523 children had either acquired or congenital heart disease. Roughly half of the sample who ...

FAU Receives Patent for Invention Which Induces and Restores Cardiac Muscle Function

... in the human heart which are caused by either congenital heart defects or heart attacks. Lemanski, Zhang ... cannot repair themselves. Furthermore, many congenital abnormalities are thought to be caused by ... levels. In addition, children who are born with congenital heart defects could have those defective areas of ...

Quest Diagnostics ClariSure(TM) Postnatal Molecular Test Receives Clinical Laboratory Approval from New York State

... New York have used our ClariSure test to identify the genetic etiology of congenital anomalies, autism and other disorders for dozens of patients whose ... implicated in some types of mental retardation, developmental disorder and congenital anomalies, as well as in autism and autism spectrum disorders. In ...

AGA Medical Corporation Launches Web-Based Stroke Education and Awareness Program Featuring Professional Football Player Tedy Bruschi

... study, known as the RESPECT trial, to investigate whether closure of a congenital heart defect using an AGA Medical device is superior to current standard ... devices have been major innovations in the treatment of the most common congenital "holes in the heart", such as atrial septal defects and patent foramen ...

Vical Completes Enrollment and Reports Positive Interim Data in CMV Vaccine Phase 2 Trial

... is used to control the disease, but does not eliminate the infection. congenital CMV infection affects one out of every hundred infants, and causes severe ... company will expand development of a CMV vaccine to address prevention of congenital disease, and if so, whether such results will be successful; whether Vical ...

Encouraging Gene Therapy Results in Genetic Form of Blindness

... intraocular adeno-associated virus-based gene therapy to treat Leber congenital amaurosis (LCA), an incurable genetic disorder that results in blindness, ... eyes did not change. In a paper entitled, "Phase I Trial of Leber congenital Amaurosis due to RPE65 Mutations by Ocular Subretinal Injection of ...

Thrombosis Guidelines Emphasize Difficult Choices for Pregnant Women

... to childhood stroke, one of the top ten causes of death in children, and congenital heart disease have been substantially expanded since the previous ... guidelines on the prevention and treatment of thrombosis related to congenital heart disease interventions include discussions of ventricular assist ...

Gene Therapy Improves Vision in Patients with Congenital Retinal Disease

... therapy to safely restore vision in three young adults with a rare form of congenital blindness. Although the patients have not achieved normal eyesight, the ... have been researching inherited retinal degenerations such as Leber congenital amaurosis (LCA), for 18 years. LCA is a group of inherited blinding ...

Study Results of GAMMAGARD S/D and GAMMAGARD LIQUID in Patients with Mild-to-Moderate Alzheimer's Disease Announced

... with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, ... with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, ...

New Research for Mechanical Support Devices in Pediatrics to Be Released at International Heart and Lung Transplant Meeting

... efficiency of organ utilization in children. Close to 1,800 children with congenital heart defects die each year, and 25 percent of the 36,000 babies born with ... is largely responsible for this," said Brian Duncan, M.D., Pediatric and congenital Heart Surgery, Children's Hospital, Cleveland Clinic. At this year's ...

New Clinical Studies Presented at the 14th World Congress of Anesthesiology Demonstrate Masimo Advancements in Patient Care

... Hospital for Sick Children in Toronto, Canada, evaluated 12 patients with congenital cyanotic cardiac lesions (CCCL) to compare noninvasive oxyhemoglobin ... said, "Accurate monitoring of oxygen saturations in children with cyanotic congenital heart defects is essential for appropriate patient management and, ...

MedImmune Presents New Pharmaco-Economic Data at American Academy of Pediatrics Regarding Infants at High Risk for RSV

... born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and ... 35 weeks gestational age), and children with hemodynamically significant congenital heart disease. The first dose of Synagis should be administered prior to ...

Baxter and The Alzheimer's Disease Cooperative Study Group to Pursue a Phase III Study of Gammagard Liquid in Patients With Alzheimer's Disease

... with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, ... with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, ...

MedImmune's Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study

... born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and ... 35 weeks gestational age), and children with hemodynamically significant congenital heart disease. The first dose of Synagis should be administered prior to ...

2,500 Cases Completed With the Magnetic Irrigated Catheter

... of patients ranging from pediatric to geriatric. Included in the Niobe clinical experience are several very compelling procedures in patients with congenital heart defects and patients with peripheral vascular occlusive disease. Altogether this represents the broadest range of cardiovascular applications ...

Injection Reverses Heart-Attack Damage

... Hospital Boston have now laid the groundwork for regenerating heart tissue after a heart attack, in patients with heart failure, or in children with congenital heart defects. In the July 24 issue of Cell , they show that a growth factor called neuregulin1 (NRG1), which is involved in the initial development ...

St. Francis Surgeon Uses Tissue Regeneration Technology to Rebuild Patients' Heart Structures

... 2007, Gerdisch, who specializes in complex heart valve surgery, became the first in the world to apply this technology inside the heart, repairing a congenital defect. "Similar uses of the ECM followed, at our and other institutions," reported Gerdisch, who is co-director of the St. Francis Midwest ...

MedImmune Funds Study to Help Gain Insights Into Full Burden of RSV Disease Among Premature Infants

... infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk ...

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

... 405 patients with idiopathic PAH or PAH associated with anorexigen use, connective tissue disease, human immunodeficiency virus (HIV) infection, or congenital systemic-to-pulmonary shunts. Patients were randomized in groups and received one of five treatments, tadalafil 2.5 mg, 10 mg, 20 mg, 40 mg or ...

FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension

... patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease. "Today, thanks to the clinical development efforts led by Eli Lilly & Company, we are thrilled to make available an ...

MedImmune Presents New Data Demonstrating Increased Risk for Medically Attended RSV in Late-Preterm Infants

... infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk ...

Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy

... the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III ...

Scientists Discover Why Teeth Form in a Single Row

... permanent teeth when lost are lost for good. U.S. adults aged 20 years and older are missing an average of four teeth due to gum disease, trauma or congenital defects. Tooth loss makes chewing difficult, causes speech problems, accelerates oral disease, and disfigures the face. Current treatments for ...

Pfizer Contributes Critical Data to URMC Drug Safety Initiative

... is an international leader in the science of heart arrhythmias and a rare genetic condition associated with an abnormal QT interval, called the congenital Long QT Syndrome (LQTS). URMC keeps an International Registry for LQTS, and follows thousands of families who have this inherited condition. One of ...

Berlin Heart's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval

... are confident it will provide positive results. Our next step is to activate the remaining IDE study sites." Dr. Charles D. Fraser, Jr., Chief of congenital Heart Surgery at Texas Children's Hospital, is the study's Principal Investigator. He commented, "The device shows exciting promise as a reliable ...

American Heart Association Journal Report: Miniaturized Heart Pumps May Be Effective for Children Awaiting Transplant

... known as BiVADs, in seven girls and two boys ranging in age from 12 days to 17 years. All had severe heart failure due to cardiomyopathy or complex congenital heart defects and weighed less than 40 kilograms (88 pounds). One child died from kidney failure before receiving a heart transplant. After 19 months ...

First European Patients Treated With the Percutaneous MitraClip(R) System

... results after implanting the MitraClip device have surpassed our initial expectations," said Dr. Franzen, interventionalist for adult structural and congenital heart disease at the University Heart Center. "The patients we treated last week have heart failure and were considered to be high risk surgical ...

Baxter Initiates Phase III Trial for the Treatment of Alzheimer's Disease

... indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity. These include, but are not limited to, congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Important Safety ...

Stem Cell Regeneration Repairs Congenital Heart Defect

... -- Mayo Clinic investigators have demonstrated that stem cells can be used to regenerate heart tissue to treat dilated cardiomyopathy, a congenital defect. Publication of the discovery was expedited by the editors of Stem Cells and appeared online in the "express" section of the journal's Web ...

Seventy Years Old and Going Strong With Down Syndrome and No Dementia: The Case of 'Mr. C' Causes Major Interest in the Scientific Community

... genes on Chromosome 21 lead to an overproduction of certain proteins that cause the phenotype of Down syndrome, including familiar facial features, congenital heart diseases, cognitive impairments, and other conditions. Previous studies of people with Down syndrome over 75 years of age have found that they ...

Positive Mid-Term Results on CryoValve(R) SG Pulmonary Human Heart Valve Presented at Western Thoracic Meeting

... The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures (RVOT), commonly performed in children with congenital heart defects. In addition, the valve can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient's ...

Pivotal Pulmonary Arterial Hypertension Study Published in The Lancet Concludes That Bosentan (Tracleer(R)) Demonstrates Benefits in Patients With Mildly Symptomatic WHO Functional Class II Disease

... also conducted clinical trials to further describe the role of bosentan in treating PAH in specific patient populations, such as patients with congenital heart disease (with Eisenmenger syndrome; BREATHE-5), patients infected with HIV (BREATHE-4). Study results are reflected in the Tracleer(R) product ...

Promise of Vical's CMV Vaccine Noted by Independent Experts

... achieve the safety and efficacy endpoints in the Phase 2 trial; whether the company will expand development of a CMV vaccine to address prevention of congenital disease; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative ...