• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Heart pump beats current standard of care for kids awaiting transplant

Heart pump beats current standard of care for kids awaiting transplant

August 9, 2012 By MassDevice staff

Berlin Heart's Excor pediatric heart pump

Children with heart failure survived longer while awaiting a heart transplant when they received therapy with Berlin Heart’s Excor pediatric ventricular assist device than when treated with the current standard of care, according to a new study.

The Excor PAD device was not without risks, but survival rates for children on the device were "significantly higher" than those in the control group, according to the study’s authors.

The study included 48 patients aged 16 and younger, split into 2 groups according to body size. Each group received the Excor implant while awaiting a donor heart, and results were compared with historical data from children who had been placed on heart-lung support machines, known as extracorporeal membrane oxygenation .

Among the smaller children, those weighing less than 10 pounds, more than half survived at least 174 days on the Excor system. The average survival rate among a similar group of children supported by ECMO was only 13 days, according to the study, which was sponsored by Berlin Heart.

The larger children survived an average of 144 days with the pump, compared with 10 days on ECMO. Overall 88% of the smaller children and 92% of the larger children survived long enough on Excor to receive a transplant, the study found.

The average wait time for an infant donor heart is 119 days, according to the FDA. Heart failure in children is less common than in adults, but there are far fewer pediatric donor hearts available.

"The Excor Pediatric Ventricular Assist Device represents a major medical advance in the treatment of children who need a heart transplant," lead author Dr. Charles Fraser said in prepared remarks. "Most of these babies and children would not otherwise survive without the support of Excor while awaiting donor hearts. I know that I speak for all of the medical professionals who participated that we are tremendously gratified to have been a part of this ground-breaking study."

The Excor system in December 2011 won FDA humanitarian device exemption after a unanimous recommendation from the federal watchdog agency’s Circulatory System Devices Advisory Panel.

The pediatric VAD is a mechanical cardiac assist device for critically ill pediatric patients suffering from severe heart failure. The system supports patients from newborns to teenagers, helping to keep them alive while they’re awaiting heart transplantation.

Berlin Heart’s pediatric VAD consists of 1 or 2 external air-driven blood pumps connected to the heart chambers and arteries by multiple tubes.

The device represents a "new era" in treating childhood heart disease, the company said, but the procedure wasn’t without complications. Most of the children in the Excor study experienced infections, strokes or bleeding, the Chicago Tribune reported.

Filed Under: News Well, Pediatrics, Structural Heart Tagged With: Berlin Heart GmbH, Clinical Trials, Organ Transplant

More recent news

  • Terumo Neuro launches new stroke catheter in the U.S.
  • EnVVeno has first-in-human heart valve data, expects FDA decision this year
  • Axoft makes Fleuron BCI material available for purchase, inks license deal with Stanford
  • BD files patent infringement lawsuit against Baxter over infusion pump tech
  • Tandem Diabetes Care subsidiary earns new FDA clearance for insulin infusion set

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy