Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Views
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Jarvik Heart Receives FDA Approval For Clinical Trial Of Miniature Heart Assist Device For Infants And Children

November 3, 2016 By Jarvik Heart

The U.S. Food and Drug Administration (FDA) has granted conditional approval to conduct an Investigational Device Exemption study of Jarvik Heart’s new miniature Left Ventricular Assist Device (LVAD) System. The study will compare the implanted, portable electrically-powered Jarvik 15mm LVAD System with the Berlin Heart EXCOR Pediatric System.

Jarvik Heart, Inc. is the manufacturer of the Jarvik 2000 adult model LVAD System, which has been used by more than 1,000 patients worldwide for up to ten years.

The 15mm-diameter infant-size pump is about the size of one AA battery and provides more blood flow as the pump speed is increased by adjustment of the control system, so as the child grows, so does the blood flow. The device is designed for patients under one year up to about age ten and may provide long-term support in children for whom no donor heart becomes available.

The approval is a milestone for the National Heart Lung and Blood Institute (NHLBI), which has funded the PumpKIN program (Pumps for Kids, Infants, and Neonates) for a decade. Jarvik Heart overcame the many high technical hurdles and demonstrated the excellent results in animal studies necessary to begin investigational use in children who otherwise have little hope of survival.

Robert Jarvik, MD, inventor of the device and Chairman of Jarvik Heart, notes, “We are excited about bringing this miniaturized pump design to pediatric heart failure patients after a decade of intense engineering effort.”

(Image credit: Jarvik Heart)

The study is managed by the New England Research Institutes and will ultimately enroll 88 patients from about 20 institutions in the U.S. and Canada. Patients who meet study criteria will randomly receive either a Jarvik 15mm LVAD System or a Berlin Heart EXCOR Pediatric System. The study will compare the ability of the two systems to provide circulatory support as a bridge to transplant, assessed over a six-month period.

Peter Hinchliffe, President of Jarvik Heart, adds, “We are thankful for the NHLBI program, without which this effort to provide lifesaving support for children would not have been possible. We look forward to the day when infants and children will be able to receive a fully-implantable LVAD that will enable a greatly-improved quality of life over currently-available options.”

Jarvik Heart originally released its Jarvik 2000 adult model LVAD System over 15 years ago, and it remains the smallest and lightest permanent LVAD system in the world. With CE mark granted in 2005 and Japanese Shonin approval in 2013, experience with the Jarvik 2000 adult model LVAD System has enabled the miniaturization necessary to create the Jarvik 15mm LVAD System.

Related Articles Read More >

This is a screenshot of the remote robotic surgery technical guidelines appearing in the World Journal of Surgery.
New technical guidelines set to advance remote robotic surgery
An illustration of Embolization Inc.'s Nitinol Enhanced Device (NED).
This nitinol vascular embolization device has another shape memory material up its sleeve
A photo of nitinol, a nickel-titanium alloy used for medical devices such as stents, heart valves, catheters and orthopedics.
What is nitinol and where is it used?
A photo of Johnson & Johnson MedTech's Polyphonic-connected Monarch robotics-assisted bronchoscopy system in the lab.
J&J MedTech’s global head of digital wants to fund your AI project
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 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.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. 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 LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Views
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe