St. Jude Medical, Inc. (STJ) recently received the CE Mark approval for marketing its Fortify and Fortify ST implantable cardioverter defibrillators (ICD) and Unify cardiac resynchronization therapy defibrillator (CRT-D) in Europe. St. Jude expects to launch these devices on a large scale in the spring of 2010. The U.S. approval is pending and the company expects to launch these products there in late 2010.

The Fortify ICD and Unify CRT-D devices are of smaller size compared to their previous generations. These devices have advanced battery technology and circuitry with more energy capacity and rapid charge times. They also have a higher longevity compared to their prior generations of ICD and CRT devices.

The new devices have several features that enhance patient safety and facilitate the working of cardiac surgeons. We think that these devices will be widely accepted by the surgeon community in view of their enhanced features. This will in turn boost demand for these devices and feed the company’s top-line growth.

St. Jude Medical is a leading designer, manufacturer and distributor of medical devices used for treating cardiovascular and neurological conditions. The company’s closest competitors are Medtronic, Inc. (MDT) and Boston Scientific Corp. (BSX).

St. Jude Medical is a leader in the mechanical heart valve market and has implanted mechanical heart valves in over 1.8 million patients worldwide.

Currently, we have a Neutral recommendation on St. Jude Medical.

Zacks Investment Research

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