Healthcare Industry News: cardiac resynchronization therapy
News Release - July 16, 2007
St. Jude Medical Announces Japanese Approval of CRT-D Products to Treat Heart Failure Patients
Two New Systems to be Available in JapanST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), in addition to reimbursement approval, for the Company's first CRT-D systems in Japan to treat heart failure patients.
Two new systems used to treat heart failure patients have been approved, including the Atlas®+ HF CRT-D (cardiac resynchronization therapy defibrillator) and the Epic® HF CRT-D that are used in conjunction with the QuickSite® left-heart lead and delivered through the Apeel® CS catheter delivery system.
"St. Jude Medical is pleased to offer products that will help physicians in Japan meet the varying needs of their heart failure patients by providing CRT-D systems with high energy, small size and flexible therapy options," said Joe McCullough, president of St. Jude Medical's International Division.
With these approvals, physicians in Japan now have two sophisticated devices that treat the complexities of heart failure by combining pacemaker therapy, ICD (implantable cardioverter defibrillator) therapy and cardiac resynchronization therapy:
- The Atlas+ HF CRT-D - the most powerful CRT-D available in Japan - is capable of delivering high output and tailored waveforms, giving added security to patients whose hearts may be especially difficult to defibrillate.
- The Epic HF CRT-D - one of the smallest CRT-Ds available in Japan - is designed for improved patient comfort, particularly for patients for whom small size is critical.
About 2.4 million people in Japan suffer from heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood.
cardiac resynchronization therapy - delivered in an ICD or a pacemaker - resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of synchrony in heart failure patients. Studies, such as the RHYTHM ICD study, have shown that CRT can improve cardiac performance and quality of life for many patients with heart failure.
The Atlas+ HF and Epic HF CRT-D devices monitor every heartbeat and provide resynchronization therapy to reduce the symptoms of moderate to severe heart failure. They also can adjust therapy to promote biventricular pacing (pacing both of the heart's lower chambers, or ventricles, to resynchronize the rhythm). In addition, the device's technology helps physicians manage patients' defibrillation thresholds (the level of energy required to stop a life-threatening arrhythmia). The devices are also designed to allow physicians to fine-tune sensing capabilities to deliver therapy only when needed.
The QuickSite left-heart lead has been demonstrated in clinical trials to have only a 1 percent dislodgement rate. Its stability and low dislodgement rate reduce the risk that additional invasive procedures will be required to replace or reposition the lead.
The Apeel CS catheter delivery system helps physicians place leads during CRT implantation procedures. Delivery tools allow physicians to deliver leads to locations in the coronary venous system that may be difficult to access with a lead or guidewire alone. Specialized delivery tools are often able to reduce the procedure time by improving access to the coronary sinus and target vein.
"St. Jude Medical is committed to the global healthcare community, as demonstrated by our significant presence in Japan as a provider of electrophysiology catheters, pacemakers and ICDs that provide new therapeutic options for physicians and patients in Japan," said Paul Bond, president of St. Jude Medical Japan Co., Ltd.
St. Jude Medical Japan Co., Ltd., and Fukuda Denshi Co., Ltd., will distribute and sell the Atlas+ HF CRT-D, the Epic HF CRT-D, the QuickSite lead and the Apeel CS catheter delivery system in Japan.
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 12,000 people worldwide. For more information, please visit www.sjm.com.
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 successes, anticipated regulatory approvals and future product launches, and projected 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 those described in the Company's Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Report on Form 10-Q filed on May 9, 2007 (see pages 23-24). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Source: St. Jude Medical
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