Healthcare Industry News:  Echocardiography 

Devices Cardiology Regulatory

 News Release - June 14, 2006

St. Jude Medical Announces European CE Mark of New Products at International Cardiac Meeting

ST. PAUL, Minn.--(HSMN NewsFeed)--June 14, 2006--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval for two new electrophysiology (EP) products - the Therapy(TM) Cool Path(TM) all-braided ablation catheter and the IBI-1400-CV Internal Cardioversion system.

The announcement was made at Cardiostim 2006, an international bi-annual meeting of cardiac specialists, which began June 14 in Nice, France.

St. Jude Medical will present results from its QuickOpt(TM) Optimization clinical study at Cardiostim's Late-Breaking Clinical Trials session on June 16, and will sponsor several symposia during the international congress.

"Cardiostim provides an important opportunity to collaborate with clinicians from around the world on the latest techniques for treating heart failure and complex cardiac arrhythmias," said Joseph H. McCullough, president of St. Jude Medical's International Division.

Newly Approved Products for European Market

The Therapy Cool Path(a) all-braided ablation catheter delivers radiofrequency energy to specific cardiac tissue, creating lesions that interrupt the abnormal electrical signals that contribute to heart arrhythmias. The catheter's tip cools tissue as energy is applied, helping physicians create deeper, more effective lesions. Its all-braided shaft gives physicians more control and precision in maneuvering and placing the catheter.

The IBI-1400-CV(a) Internal Cardioversion system helps physicians provide cardioversion (restoring a patient's normal heart rhythm) -- via catheter -- quickly and simply during EP procedures with lower voltage than is necessary for successful external cardioversion. Physicians can flip a switch to change the catheter from a diagnostic tool to providing cardioversion.

Late-Breaking Clinical Trials

St. Jude Medical will present results from its QuickOpt Optimization U.S. IDE (investigational device exemption) clinical trials at Cardiostim's Late-Breaking Clinical Session on Friday, June 16.

QuickOpt is designed to help physicians optimize their patients' cardiac output by accurately assessing and reprogramming cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD) devices during patient follow-up visits. The clinical studies compared QuickOpt with Echocardiography (echo), the most widely used optimization method, which typically takes between 30 and 120 minutes. Because echo-based optimization is time consuming and expensive, it currently is not routinely performed for most patients receiving ICDs and CRT-Ds, and is usually reserved for those patients who have not yet responded to CRT therapy.

Other St. Jude Medical Highlights

St. Jude Medical will also demonstrate other products recently released in Europe, including:
  • The EnSite® System Version 6 software, which creates highly detailed, three-dimensional cardiac models during an EP procedure. Physicians create the model in small sections that join together automatically and more accurately show the openings, ridges and curves in the heart. Physicians then use the models to collect information about the heart's electrical activity and assist them in diagnosing and treating many arrhythmias, including atrial fibrillation (AF).
  • The Agilis(TM) NxT Steerable Introducer reduces the puncture size required when physicians access the left side of the heart, yet maintains a larger inside diameter to help physicians deliver a wide variety of catheters.
  • The Inquiry(TM) Optima(TM) PLUS Steerable Diagnostic Catheter helps physicians map the heart's atria with a 24-electrode catheter that allows physicians to collect more diagnostic data, more quickly when used with St. Jude Medical's newly approved EnSite System Version 6 software. Using this 3-D imaging technology, the physician will "see" the catheter's position inside the heart.
  • The Safire(TM) Ablation Catheter, featuring the new ComfortGrip(TM) handle, can be easily integrated into any existing radiofrequency generators, and gives physicians improved comfort and control during electrophysiology procedures.
  • The Merlin(TM) Patient Care System, a state-of-the-art programmer for ICDs and pacemakers, which helps physicians conduct patient follow-up exams more efficiently and quickly using an interface that mimics the natural workflow of a clinic.
  • The Cardiac Positioning System (CPS(TM)) family of lead delivery tools for left-heart lead placement, designed to give physicians greater control and precision when navigating the challenging and critical left side of the heart during CRT device implants.
  • The Riata® ST lead, the world's-thinnest ICD lead, which helps physicians navigate more easily through a patient's veins.
  • The QuickSite® XL 1058T lead, designed with a more pronounced S-shaped curve for increased stability in patients with average- to large-size veins.
  • The Victory® pacemaker family, which introduces an important combination of features including VIP(TM) (Ventricular Intrinsic Preference) designed to minimize right ventricular pacing, optimized settings to save time at implant, and faster follow-up exams with 80 percent of standard follow-up testing automatically reported by the device.
Other St. Jude Medical-sponsored events or symposia at Cardiostim 2006 include:
  • A live case broadcast of an AF catheter ablation performed by physicians in Toulouse, France, using St. Jude Medical's NavX(TM) 3D Mapping System. The program - "New Tools for Radiofrequency Catheter Ablation" - will be broadcast on June 15.
  • Three symposia on advances in cardiac care: "Optimized Cardiac Resynchronization Therapy at the Blink of an Eye - New Approaches" on June 14; "Device Follow-Ups are History - From Now On" on June 15; and "Curative AF Treatments at an Early Stage" on June 16.
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., St. Jude Medical employs approximately 10,000 people worldwide. For more information, please visit

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 success, regulatory approvals, anticipated future product launches, 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 the risk factors described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and the cautionary statements described in the Company's Quarterly Report on Form 10-Q filed on May 9, 2006 (see pages 29-30). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

(a) Product not approved for commercial distribution in the United States.

Source: St. Jude Medical

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