Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - May 12, 2010

St. Jude Medical Announces FDA Approval of Unify CRT-D and Fortify ICD

New products help ensure effective therapy delivery, have longer battery life and can be implanted through a smaller incision due to reduced size

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval and first U.S. implants of its Unify™ cardiac resynchronization therapy defibrillator (CRT-D) and Fortify™ implantable cardioverter defibrillator (ICD). The new devices feature advanced battery technology and circuitry that allow for the smallest device footprint in the industry and rapid charge times, without any compromise in device longevity or power.

The Unify CRT-D and Fortify ICD have 45J of stored energy and can deliver 40J, the highest energy of any ICD available today. This high energy capacity gives these devices the ability to provide a greater safety margin, which could increase the chances that therapy will be successful for patients who may need more energy to correct their heart rhythm. Increasing the chance that therapy will be successful also decreases the chance that additional electrodes, such as a subcutaneous lead, will be required to defibrillate the heart. The energy capability of a device is particularly important for patients who have an enlarged heart, low ejection-fraction, advanced heart failure or previously demonstrated a high defibrillation threshold (the amount of energy required to shock the heart back to a normal rhythm).

The devices’ narrow shape, along with their small footprint, allows physicians to implant them using a smaller incision, leading to less time spent closing the incision and a reduced scar for the patient. The company’s SJ4 lead connector system further streamlines the procedure by reducing the number of set screws and connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient’s chest.

“These devices offer a number of new features designed to address many of the clinical issues facing our patients while still delivering the reliability, power and longevity I expect from a St. Jude Medical device,” said Dr. Robert P. Styperek, F.A.C.C., Harbin Clinic Physician, Director of Electrophysiology, at Redmond Regional Medical Center in Rome, Ga. “The devices’ smaller shape, combined with the SJ4 connector system, streamlines the implant procedure and can make the device more comfortable for patients. To become accustomed to this outstanding improvement, all I need to do now is shorten the length of my incision.”

Both devices also have features designed to reduce inappropriate or unnecessary defibrillation therapy, while ensuring effective therapy occurs when the patient needs it. The features include advanced sensing technology and more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks.

“The release of the Unify CRT-D and Fortify ICD families is a strong demonstration of our commitment to providing physicians with technology that puts more control in their hands,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “Our goal with these product lines is to provide physicians with solutions that address their most significant clinical challenges, including patient safety and inappropriate therapy, and to do so while reducing the size of the device.”

An ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). Approximately 325,000 people per year in the U.S. die suddenly of SCD.

A CRT-D device resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients, and provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure. Studies have shown that CRT (cardiac resynchronization therapy) can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. About five million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.

The Unify CRT-D and Fortify ICD previously received European CE Mark approval and were recently fully-launched in Europe.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit 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 Risk Factors and Cautionary Statements sections of the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2010. 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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