FDA clears use of MRI for Impulse Dynamics' Optimizer

By AuntMinnie.com staff writers

January 20, 2021 -- The U.S. Food and Drug Administration (FDA) has cleared for conditional use MRI for patients receiving cardiac contractility modulation (CCM) therapy using technology from Impulse Dynamics.

The company's Optimizer technology is implanted in a patient and delivers CCM therapy, which optimizes heart contraction by allowing more oxygen-rich blood to reach the body. This system aims to improve outcomes for patients who receive treatment for moderate to severe heart failure.

The FDA's action will enable MRI scans to be performed on patients who have been implanted with Optimizer, a device about the size of a pacemaker. The device delivers timed electrical pulses to the heart during the absolute refractory period of the beating cardiac cycle, just after the heart contracts.

Optimizer has been cleared for use in the U.S. and some 40 other countries. About 5,000 have been treated with the device.


Copyright © 2021 AuntMinnie.com
 

To read this and get access to all of the exclusive content on AuntMinnie.com create a free account or sign-in now.

Member Sign In:
MemberID or Email Address:  
Do you have a AuntMinnie.com password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?
Sign in using your social networking account:
Sign in using your social networking
account: