St. Jude Medical Receives CE Mark Approval for Pacing Lead Labeling That Will Expand Patient Access to MRI Scans
CE Mark approval expands the company’s portfolio of cardiac rhythm devices with MRI compatibility
ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today 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 St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
1. St. Jude Medical Product Performance Report; 2013 Edition, Implantable Electronic Systems Division, Dec, 2013. Contacts
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Kate Stoltenberg, 651-756-3388
Media Relations
kstoltenberg@sjm.com
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