St Jude Medical has announced the CE mark approval for magnetic resonance (MR) conditional labeling for its Quadra Assura cardiac resynchronisation therapy defibrillator (CRT-D).
The Quadra Assura CRT-D and Quadra Assura MP CRT-D with MultiPoint Pacing are now approved for use with magnetic resonance imaging (MRI) scanning systems at 1.5 Tesla.
“The Quadra Assura CRT-D MRI allows patients to continue to be actively paced and continuously monitored with the quadripolar pacing technology while having the capability to get an MRI scan if needed,” says Giovanni Forleo, electrophysiologist at the University Hospital of Tor Vergata, Rome, Italy. “Being able to offer MRI-compatible technology without compromising care decisions is extremely important; this is yet another valuable tool for us to treat patients living with heart failure.”
According to a company release, the Quadra Assura CRT-D has been shown to demonstrate an improvement in quality of life and reduce hospitalisation rates by 53%.
“Adding MRI availability to our market-leading quadripolar technology advances options for patients and ensures future access to diagnostic imaging they may need in their heart failure treatment,” says Eric S Fain, group president at St Jude Medical. “
MultiPoint Pacing is an investigational device and is not commercially available in the USA, MRI labeling is not approved in the USA or Australia for these devices.