The Minnesota medtech titan just 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.
"St. Jude Medical plans to submit testing data in key markets around the world such as Europe, Japan, Australia and the U.S. for MRI conditional labeling on several additional existing products including the Fortify Assura implantable cardioverter defibrillator (ICD), Ellipse ICD, Quadra Assura cardiac resynchronization therapy defibrillator (CRT-D), Durata and Optisure defibrillation leads," according to a company statement.
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.
"St. Jude Medical is committed to providing MRI compatible pacing solutions to patients and physicians around the world," group president Dr. Eric Fain said in prepared remarks. "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."
St. Jude won CE Mark approval in 2011 for its MRI-friendly Accent pacemaker and the older Tendril lead.