St. Jude Medical Announces FDA Approval of Atlas II ICD and Atlas II Heart Failure Devices; Powerful, High-Energy Devices Are Designed to Help Patients Whose Hearts Are Especially Difficult to Defibrillate.
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
See: New York Stock Exchange :STJ) today announced U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) approval of new, powerful devices for treating patients with potentially lethal heart arrhythmias and heart failure.
The Atlas(R) II ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.
abbr. (implantable cardioverter defibrillator) and the Atlas(R) II HF CRT-D (cardiac resynchronization therapy defibrillator) devices are capable of delivering unsurpassed energy, giving added security to patients whose hearts are especially difficult to defibrillate de·fib·ril·late
tr.v. de·fib·ril·lat·ed, de·fib·ril·lat·ing, de·fib·ril·lates
To stop the fibrillation of (a heart) and restore normal contractions through the use of drugs or an electric shock. . The new devices also feature significantly enhanced telemetry speed for faster communications - up to five times faster than predecessor devices - which results in quicker, more convenient follow-up visits for patients and physicians.
In addition, the new Atlas devices include a "patient notifier" that gently vibrates to alert patients, including those who have difficulty hearing, of critical changes in device function so they know to contact their physicians.
"This technology makes devices faster to use, particularly when downloading stored electrograms; and the new vibrating patient notifier is an innovative and beneficial feature for those patients who may have difficulty hearing the audio alerts that have been standard in the industry," said Robert Styperek, M.D., from Harbin Clinic in Rome, Ga.
In addition to patient notification, speed and energy (42 joules of stored and 36 joules of delivered energy), the Atlas II devices also feature:
--Proprietary St. Jude Medical technology designed to help devices meet the needs of patients who require high levels of defibrillation Defibrillation Definition
Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. therapy, and to allow optimizing of sensing parameters that may protect against inappropriate ICD shocks.
--AutoIntrinsic Conduction Search, which is intended to promote more natural heart function and minimize ventricular pacing, which is an important clinical consideration since studies such as St. Jude Medical's DAVID (Dual-Chamber And VVI Implantable Defibrillator) trial have shown that excessive ventricular pacing may contribute to heart failure in some patients.
"Because of their advanced features and high-energy output, the Atlas II devices can help physicians address the needs of even their most challenging patients," said Michael J. Coyle, president of St. Jude Medical's 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. Division. "These devices enhance our portfolio of products designed to meet the needs of clinicians and patients - including the recently launched Merlin(TM) Patient Care System, with its suite of advanced diagnostics, the advanced QuickSite(R) LV lead for 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. therapy and the thin Riata(R) ST lead for ICD therapy, plus the Cardiac Positioning System (CPS(TM)) LV lead delivery tools for implanting CRT systems."
The Atlas II ICD and Atlas II HF CRT-D, which will be released for sale in the U.S. in August, are two of more than 20 new cardiac rhythm management products that St. Jude Medical plans to introduce this year.
About the size of a pocket watch, an ICD is implanted in the chest and provides therapy through a small insulated wire (called a lead) for potentially lethal fast heart rates (ventricular tachycardia or ventricular fibrillation). These arrhythmias can cause sudden cardiac death Sudden Cardiac Death Definition
Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. (SCD ScD [L.] Scien´tiae Doc´tor (Doctor of Science).
SCD 1 Sickle cell disease, see there 2 Subacute combined degeneration, see there 3 Sudden cardiac death, see there ), a condition that kills more than 450,000 people in the United States each year, according to the Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. (CDC See Control Data, century date change and Back Orifice.
CDC - Control Data Corporation ).
A CRT-D device provides cardiac resynchronization therapy (CRT) for patients with heart failure (HF), a progressive condition that weakens the heart, causes the lower chambers of the heart (ventricles) to beat out of sync, and results in the heart's inability to effectively pump an adequate supply of blood to the body. CRT - available through an ICD or a pacemaker - provides a better quality of life by resynchronizing the beating of the heart's lower chambers. Approximately 550,000 new patients are diagnosed with HF each year in the United States, according to the American Heart Association American Heart Association (AHA),
n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. .
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 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 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.