St. Jude wins CE Mark for MR-safe Quadra Assura CRT-D

St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union for MRI-conditional labelling for its Quadra Assura cardiac resynchronization therapy defibrillator.

The Quadra Assura CRT-D is compatible with MRI scanning systems up to 1.5 Tesla, St. Paul, Minn.-based St. Jude said.

“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. 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,” Dr. Giovanni Forleo of Rome’s University Hospital of Tor Vergata said in prepared remarks.

St. Jude said its Quadra Assura CRT-D was the 1st-to market quadripolar multipoint CRT-D, with technologies that allow for multiple pacing locations on the left side of the heart.

“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. We remain committed to being the leader in quadripolar technology while continuing to focus on improving patients’ quality of life,” St. Jude group prez Dr. Eric Fain said in a press release.

Last September, St. Jude said it was taking many of its already-approved devices back to regulators in order to win approval to label them as MRI-friendly.

The Minnesota medtech titan won CE Mark approval in the European to market its previously approved Tendril STS and IsoFlex Optim pacing leads as safe to use with MRI, but the company isn’t going to stop there.

The company kicked off the MRI-safe labeling initiative with extended European approval for the Tendril STS and IsoFlex Optim leads. The new CE Mark means St. Jude can market the already-approved leads as MRI-friendly and provide patients already implanted with the devices some peace of mind should they need diagnostic imaging.

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