St. Jude Medical, Inc., a global medical device company, has 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 patients1.In addition to this approval, St. Jude Medical also today 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 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.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.About the companyAs a true leader, St. Jude Medical is committed to meeting or exceeding the high quality and safety expectations of our patients, customers and regulators. Quality is the shared belief that unites all 16,000 of our employees – it is built into everything we do and is the guiding principle behind every product we create.Headquartered in St. Paul, Minn., USA, St. Jude Medical is a global medical technology leader focused on six key treatment areas:Heart Failure – St. Jude Medical is pioneering heart failure disease management with innovative solutions that help reduce hospitalizations and improve the quality of life of patients.Arrhythmias – Our unparalleled product portfolio gives physicians the diagnostic, access, mapping and therapy solutions they need with designed integration for enhanced diagnosis and treatment of heart arrhythmias.Vascular Disease – Our breakthrough solutions guide health care providers in their treatment decisions – helping improve patient outcomes and provide cost savings opportunities.Structural Heart – Our catheter-based and surgical treatment solutions for structural heart disease are focused on ease-of-use and improving quality of life.Chronic Pain – Patients around the world benefit from our transformational pain management technologies that enable them to return to work and live fuller, more satisfying lives.Neurological Diseases – As pioneers in the field, St. Jude Medical has developed cutting-edge neuromodulation technologies for the treatment of neurological diseases.