• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      Urine Test for Parkinson’s Disease

      Urine Test for Parkinson’s Disease

      Investigating Bacterial Motion for New Treatment Strategies

      Investigating Bacterial Motion for New Treatment Strategies

      Smart Sutures Sense Inflammation, Deliver Drugs, Cells

      Smart Sutures Sense Inflammation, Deliver Drugs, Cells

      siRNA as a COVID-19 Treatment

      siRNA as a COVID-19 Treatment

    • Radiology
      Wearable Ultrasound for Deep Tissue Monitoring

      Wearable Ultrasound for Deep Tissue Monitoring

      Implanted Ultrasound Lets Chemo Access Brain

      Implanted Ultrasound Lets Chemo Access Brain

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

    • Cardiology
      Wearable Ultrasound for Deep Tissue Monitoring

      Wearable Ultrasound for Deep Tissue Monitoring

      Pencil-on-Paper Wearable Sensor

      Pencil-on-Paper Wearable Sensor

      Cell Culture Chamber Mimics Mechanical States of Disease

      Cell Culture Chamber Mimics Mechanical States of Disease

      Chest Wearable Provides Key Heart Measurements

      Chest Wearable Provides Key Heart Measurements

    • Surgery
      Smart Sutures Sense Inflammation, Deliver Drugs, Cells

      Smart Sutures Sense Inflammation, Deliver Drugs, Cells

      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

    • Nanomedicine
      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Get Lymphatic Vessels Pumping

      Nanoparticles Get Lymphatic Vessels Pumping

      Bottlebrush Particle for Synergistic Drug Combinations

      Bottlebrush Particle for Synergistic Drug Combinations

    • Military Medicine
      Wearable Can Take Multiple Sweat Samples

      Wearable Can Take Multiple Sweat Samples

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

    • Rehab
      Temperature Feedback for Prosthetic Limbs

      Temperature Feedback for Prosthetic Limbs

      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

      Knitted Glove Massages the Hand to Treat Edema

      Knitted Glove Massages the Hand to Treat Edema

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

German-made Heart Pump for Children Needing Heart Transplants

January 21st, 2008 Josh Umbehr Cardiac Surgery, Pediatrics

Back in 2005 we covered the Berlin Heart EXCOR, but now Texas physicians will utilize FDA’s “compassionate use” rule to study its effectiveness in the pediatric population.

Charles D. Fraser, Jr., MD, chief of pediatric and congenital heart surgery at Texas Children’s and professor, Michael E. DeBakey Department of Surgery at Baylor College of Medicine, will serve as the National Principal Investigator for the Investigational Device Exemption prospective study. As NPI, Fraser will work in cooperation with 10 U. S. hospitals and two Canadian hospitals, in collecting and reporting data to the United States Food and Drug Administration on the safety and probable benefit of the pediatric heart pump. At the study’s conclusion, Berlin Heart, Inc. will present those data to the FDA for consideration of approval of the EXCOR Pediatric VAD for use in the U.S.
“The Berlin Heart holds a lot of promise for infants and children whose hearts are failing,” said Fraser. “It’s extremely gratifying to be part of such a collaborative study involving the FDA and the other leading heart centers around the nation in exchanging information that will ultimately benefit many pediatric heart patients.”
The Berlin Heart EXCOR Pediatric VAD, which comes in graduated sizes to fit a pediatric population from newborns to teens, is the only pediatric heart pump that provides medium-to-long-term mechanical circulatory support for infants and children awaiting heart transplantations. The device has been approved in Germany and Europe since 1992, but does not have FDA approval for use in the U. S.
“The Berlin Heart is especially attractive as an option for circulatory support in babies and small children awaiting heart transplantation,” said Fraser. A particular advantage is that children can get up, walk around and be kids again while they are recovering and waiting for a donor heart.”
Along with Texas Children’s Hospital, 11 hospitals will participate in the study: Arkansas Children’s Hospital, Little Rock; Boston Children’s Hospital; Children’s Hospital of Wisconsin in Milwaukee; Riley Children’s Hospital, Indianapolis; Mott Children Hospital, Ann Arbor; Lucille Packard Children’s at Stanford; St. Louis Children’s Hospital; Seattle Children’s Hospital; and Children’s Hospital at the University of Alabama at Birmingham. Stollery Children’s Hospital in Edmonton, and the Hospital for Sick Kids in Toronto are participating in Canada.
Berlin Heart EXCORIn addition to the IDE study, Texas Children’s Heart Center has been named the first Berlin Heart Reference and Training Center in the United States – offering support to hospitals not participating in the study who seek to use the Berlin Heart for the first time. Dr. David Morales, pediatric cardiovascular surgeon at Texas Children’s and assistant professor, Michael E. DeBakey Department of Surgery at Baylor College of Medicine, will direct a training team comprised of cardiac surgeons, cardiologists, perfusionists, operating room nurses, ICU nurses, research nurses and a designated Berlin Heart Fellow. The team will hold periodic training sessions at Texas Children’s, and they will also travel to other hospitals to provide instruction on-site.
Between 2000 and 2007, prior to FDA approval to begin the study, pediatric hospitals in the U. S. used the Berlin Heart under the FDA’s emergency or <strong>“compassionate use” regulations</strong>. Each time a physician wanted to implant the Berlin Heart in a child dying of heart failure, a special appeal had to be made to the FDA for approval on a case-by-case basis. If approved, the Berlin Heart had to be flown from Germany while the child waited, possibly losing precious time. Also, under prior FDA regulations, the device could not be stored in the U.S., but had to be flown back to Germany if it was not used. Now with the IDE study in place, participating centers may keep the device on hand for easier access for their patients with failing hearts.

Press Release…
Berlin Heart…

Josh Umbehr

Josh Umbehr, MD founded AtlasMD Concierge Family Practice, one of the fastest growing insurance-free practices in the country. Currently developing an industry leading platform for direct primary care physicians: Atlas EMR Software for Concierge Medicine.

Sponsored

Packaging Compliance Labs (PCL) Celebrates Site Expansion in Grand Rapids, MI

Novel Approach to Assessing Lung Function Enables Improved Detection, Diagnosis and Treatment Decisions in Subject Exposed to Military Burn Pits

U.S. Patent Office Grants Additional Patent Protection For  Exoskeleton Focal-Force Angioplasty Platform

U.S. Patent Office Grants Additional Patent Protection For Exoskeleton Focal-Force Angioplasty Platform

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

interviews & reviews
Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Imagene Profiles Cancer Biomarkers in Real Time

Imagene Profiles Cancer Biomarkers in Real Time

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

  • Subscribe
  • Contact us
  • Submit
  • About
  • Back to top
Medgadget

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

  • About
  • Editorial policies
  • Contact
  • Terms of Service
  • Privacy
  • Submit press release
  • Advertise
© Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email