St. Jude Medical Announces European CE Mark of New Products at International Cardiac Meeting.ST. PAUL, Minn. -- St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , Inc. (NYSE NYSE
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STJ San Giljan (postal locality, Malta) ) 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 Cardioversion Definition
Cardioversion refers to the process of restoring the heart's normal rhythm by applying a controlled electric shock to the exterior of the chest. 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 An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and ) clinical trials at Cardiostim's Late-Breaking Clinical Session on Friday, June 16.
QuickOpt is designed to help physicians optimize their patients' cardiac output cardiac output
n. Abbr. CO
The volume of blood pumped from the right or left ventricle in one minute. It is equal to the stroke volume multiplied by the heart rate. by accurately assessing and reprogramming Reprogramming refers to erasure and remodeling of epigenetic marks, such as DNA methylation, during mammalian development. After fertilization some cells of the newly formed embryo migrate to the germinal ridge and will eventually become the germ cells cardiac resynchronization therapy (CRT (1) (C RunTime) See runtime library.
(2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons. ) and implantable cardioverter defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.
abbr. ) devices during patient follow-up visits. The clinical studies compared QuickOpt with echocardiography Echocardiography Definition
Echocardiography is a diagnostic test that uses ultrasound waves to create an image of the heart muscle. Ultrasound waves that rebound or echo off the heart can show the size, shape, and movement of the heart's valves and (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(R) 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 atrial fibrillation
Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. (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 Atria
The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. 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(R) ST lead, the world's-thinnest ICD lead, which helps physicians navigate more easily through a patient's veins.
--The QuickSite(R) XL 1058T lead, designed with a more pronounced S-shaped curve for increased stability in patients with average- to large-size veins.
--The Victory(R) 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 Catheter Ablation Definition
Catheter ablation of an irregular heartbeat involves having a tube (a catheter) inserted into the heart through which electrical energy is sent to either reset the heartbeat or stop the heart from beating so a mechanical 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 Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. , 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 www.sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Form 10-K
A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.
See 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 Form 10-Q
See 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.