Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

SynCardia CE marks artificial heart power system

This article was originally published in Clinica

Executive Summary

SynCardia Systems has CE marked the Freedom driver system, which powers its CardioWest Total Artificial Heart, for sale in Europe. The Tucson, Arizona firm claims the device "will allow stable European Total Artificial Heart patients to enjoy a quality lifestyle…while they wait for a matching donor heart." Immediately after a patient receives a Total Artificial Heart, hospital drivers are used to power the implant until their condition stabilises. Once stable, patients can be switched to the Freedom driver and discharged from the hospital. The driver weighs 13.5lbs (6.1kg), and includes two lithium ion batteries and a power adaptor. It can be carried by the patient in a specially designed backpack or shoulder bag. It is 60% lighter than SynCardia's older CE-marked "proof of concept" portable driver, which weighs approximately 35 lbs and is transported in a wheeled caddy. SynCardia has submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom driver in the US.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT053864

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel