Patient Access to MRI Scans Expanded with CE Marking Approval for Pacemaker Leads

New pacemaker leads have received CE marking approval, allowing existing and future patients with the devices access to magnetic resonance imaging (MRI) scans in Europe.

St. Jude Medical, Inc. (St. Paul, Minnesota, USA), a global medical device company, has announced CE marking approval of updated labeling for its Tendril STS and IsoFlex Optim. The leads are used with the Accent MRI pacemaker, an advanced pacing platform that provides the added benefit of MRI scanning capability.


“St. Jude Medical is committed to providing MRI-compatible pacing solutions to patients and physicians around the world,” said Eric S. Fain, MD, group president of St. Jude Medical. “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.”

Yearly, approximately one million pacemakers are implanted worldwide. The Tendril STS and IsoFlex Optim pacing leads are built on the Tendril and IsoFlex lead platforms, and include the company’s exclusive Optim insulation material. Optim insulation is a hybrid insulation material that blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane. This combination is designed to provide increased durability, and to improve flexibility, handling characteristics and control during implant procedures. The updated labeling further demonstrates the safety of the Tendril STS and IsoFlex Optim pacing leads, which were originally designed to be used in an MRI setting. In actively monitored registries, the Tendril STS and IsoFlex Optim pacing leads have demonstrated effectiveness with over 99% survivability in patients.

St. Jude Medical reported, in addition to this approval, that it plans to seek updated labeling for many existing products to allow patients the ability to safely undergo MRI scans. St. Jude Medical plans to submit testing data in key markets worldwide such as Europe, Japan, Australia, and the United States 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.

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