St. Jude Pacing Leads Now CE Marked as MRI Friendly

St. Jude Medical, Inc. has gained CE Mark approval that will allow patients fitted with its Tendril™ STS and IsoFlex™ Optim™ pacing leads, to undergo 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.

Background

MRI compatibility (or MRI conditionality as it is more correctly termed) is desirable in a pacing technology because of the high probability that an increasing population of implantees will at some point benefit from the use of this diagnostic tool. Companies continue to chase the MRI-compatible claim, one such being St. Jude Medical, for whom the long story of lead insulation seems to be yielding more good news than bad these days. The company’s Tendril STS and IsoFlex Optim pacing leads are built on the Tendril and IsoFlex lead platforms, and include the company’s exclusive Optim insulation, a hybrid material that blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane. These two devices were originally designed to be used in an MRI environment and in actively monitored registries have demonstrated proven reliability with over 99 percent survivability.

St. Jude Medical says it plans to seek updated labeling for many existing products in order to allow patients the ability to safely undergo MRI scans. It will 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.

Company comments

“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.”

Source: St. Jude Medical, Inc., Business Wire

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