September 26, 2014 — St. Jude Medical Inc. announced CE mark approval of updated labeling for its Tendril STS and IsoFlex Optim pacing leads, allowing existing and future patients with the devices access to magnetic resonance imaging (MRI) scans. 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, M.D., 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.”
Each year, 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 environment. In actively monitored registries, the Tendril STS and IsoFlex Optim pacing leads have demonstrated proven reliability with over 99 percent survivability in patients.
In addition to this approval, St. Jude Medical also announced that it plans to seek updated labeling for many existing products in order to allow patients the ability to safely undergo MRI scans. St. Jude Medical plans to submit testing data in key markets around the world 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.
A lead is a thin insulated wire that is placed through the vein as part of a pacemaker implantation procedure. Its tip is attached to the heart tissue, and its other end connects to the pacemaker. A lead carries electrical impulses from the pacemaker to the heart and transmits information from the heart back to the implanted device.
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St. Jude Medical Product Performance Report; 2013 Edition, Implantable Electronic Systems Division, Dec. 2013.