St. Jude Medical Announces Regulatory Approvals and Market Launch of the World's Thinnest ICD Lead

Business Wire, April 10, 2006

ST. PAUL, Minn. -- St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration regulatory approval and market launch of the Riata(R) ST lead, the world's thinnest implantable cardioverter defibrillator (ICD) lead. The thin size is designed to make navigation easier through difficult anatomy in cardiac patients, enabling physicians to more precisely place leads, which is critical for successful ICD therapy.

"The Riata ST lead handles with the flexibility of a bradycardia lead while performing like an ICD lead," said G. Joseph Gallinghouse, M.D., of Texas Cardiac Arrhythmia, a division of Texas Cardiovascular Consultants in Austin, Texas, who implanted the first lead. "The ultra-thin diameter makes it easier to handle and to precisely position at the desired cardiac site so that patients can receive appropriate ICD therapy."

"The thin diameter of the Riata ST lead preserves venous space, which is an important consideration when treating patients with implantable devices, especially those with pre-existing or multiple lead systems, because it minimizes restriction to blood flow," added Steven M. Greenberg, M.D., of St. Francis Hospital in Roslyn, N.Y.

In addition to the world's smallest ICD lead body at 6.3 French, the device also introduces innovative isodiametric defibrillation coils, which are intended to prevent tissue in-growth and allow for easier explants.

"The Riata ST lead has design enhancements such as silicone back-filled coils and a low profile wire to create a smaller lead that is more isodiametric, engineered to give physicians both ease of implant and the potential for reduced tissue in-growth," said Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management Division.

The reduction in diameter for the Riata(R) ST lead, relative to previous versions of the Riata(R) ICD lead family, was achieved primarily through the use of an innovative flatware component technology that allows for reduction in the diameter of the lead's conductor coil. This change, along with other improvements made to the Riata(R) lead design, enable improved lead handling characteristics without compromising the long-term performance of the lead.

The new lead, to be launched in the U.S. on April 17, provides steroid-elution, a time-released delivery of a steroid near the pacing electrode, which is intended to improve the long-term pacing threshold. It is available in a true bipolar version, which is engineered to allow more precise sensing of the heart's rhythms. It is also available in an integrated version, which is designed to reduce anodal stimulation when used with CRT-D systems.

The Riata(R) ST lead will be available in single-coil and dual-coil versions, as well as 17 mm and 21 mm tip-to-proximal coil spacing, to accommodate physicians' preferences and individual patient needs. Its multi-lumen leads feature a modern titanium tip housing with radiopaque markers designed for better visibility during implantation procedures.

To meet individual patient needs, the lead may be paired with St. Jude Medical's high-output Atlas(TM) ICD family for unsurpassed power in rate-adaptive dual- and single-chamber implantable cardioverter defibrillator therapy.

The Riata(R) ST lead is available in six active-fixation models, which attach in the heart using an extendable-retractable helix mechanism, and six passive-fixation models. The lead features a silicone insulated body designed for greater flexibility, along with Fast-Pass(TM) coating to promote ease of movement.

ICD leads come in many variations (unipolar versus bipolar, single coil versus dual coil, as well as multiple lengths and other characteristics) to provide a broad range of products to meet physician and patient requirements. Because many physicians develop strong and specific preferences for certain types of leads, or need the option of alternate configurations for special cases, St. Jude Medical offers a wide range of lead options.

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (known as ventricular tachycardia or ventricular fibrillation) by delivering energy to the heart through an insulated wire or lead. Defibrillation leads also have the ability to sense cardiac activity, which is then transmitted back to the ICD to determine whether the potentially life-saving therapy should be delivered. Within the heart, the defibrillation lead contains one or two electrical coils, depending on physician preference. Electrical energy forms a circuit from the coil or coils to the ICD and back to the heart.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., the Company employs approximately 10,000 people worldwide. For more information, please visit www.sjm.com.