St. Jude Medical Gets CE Mark Approval For Tendril STS, IsoFlex Optim

(RTTNews) - Medical device company St. Jude Medical, Inc. (STJ) Monday said it received CE Mark approval for updated labeling of its Tendril STS and IsoFlex Optim pacing leads, which is used for magnetic resonance imaging or MRI scans. The leads are used with the Accent MRI pacemaker, an advanced pacing platform that provides the added benefit of MRI scanning capability.

The updated labeling further shows the safety of the Tendril STS and IsoFlex Optim pacing leads, which were originally designed to be used in an MRI environment.

Eric Fain, group president of St. Jude Medical commented: "We believe many patients can benefit from pacing therapies with MRI scanning capabilities when they have additional health concerns. We are dedicated to the development of existing and future heart rhythm technologies that are compatible with this important diagnostic tool."

The company also said it plans to seek updated labeling for many of its existing products in for enabling patients to safely undergo MRI scans.