St. Jude Medical Announces Launch of Unify and Fortify Devices with New Heart Failure Monitors in India
New products help ensure effective therapy delivery even for patients with high defibrillation thresholds, provide additional disease management monitors for heart failure patients or patients at risk for sudden cardiac arrest and can be implanted through a smaller incision due to reduced size.
- (1888PressRelease) June 07, 2011 - St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the launch of the Unify™ cardiac resynchronisation therapy defibrillator (CRT-D) and Fortify™ implantable cardioverter defibrillators (ICD). The reduced size of these new devices compared to those of previous generations creates the smallest available device footprint in the industry.
"Our foremost objective in launching the Unify and Fortify devices is enhanced patient safety without compromise in device longevity or power. With the World Health Organisation (WHO) estimating that India is likely to emerge as the global capital of heart diseases by 2025, these devices provide important steps toward improving the management of cardiac conditions," said Kaustav Banerjee, country manager of St. Jude Medical India.
The Unify CRT-D and Fortify ICD feature advanced battery technology and circuitry that allow for a smaller device, with more energy capacity and rapid charge times, all while increasing device longevity. 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). These devices feature 40J of delivered energy (45J stored) - the highest energy level available in the industry - helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.
Because of the devices' narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company's DF4 lead connector system further streamlines the procedure by reducing the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient's chest.
The Unify CRT-D and Fortify ICD also incorporate the new CorVue™ pulmonary congestion monitoring algorithm. This new feature alerts physicians when a patient's heart failure may be worsening, as evidenced by changes in electrical signals that can be correlated to increased congestion, or fluid retention, in the chest area.
Both devices also have features that are designed to assist in the reduction of unnecessary shocks, including painless anti-tachycardia pacing, which can be used for fast ventricular arrhythmias prior to or while the device is preparing to deliver shock therapy, and other enhanced technology for reducing inappropriate therapy.
The company's ShockGuard technology is designed to reduce inappropriate and unnecessary shocks for patients. The programming in ShockGuard discriminates between rhythms that require defibrillation therapy and those that do not. Additionally, the advanced sensing technology designed to avoid sensing unwanted signals (T-waves) and offer more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks.
Commenting on the usefulness of the devices, Dr. Mohan Nair, Chief of Cardiology, Max Super Specialty Hospital said, "Sudden cardiac arrest and arrhythmia disorders are often ignored to the detriment of patients throughout India. The Unify and Fortify devices offer several new important features that make the procedure and the follow up more comfortable for patients, removing an important barrier for those seeking treatment."
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). Data reveals that Sudden Cardiac Deaths account for more than 40-45 percent of cardiovascular deaths in India and out of this almost 80 percent are due to heart rhythm disturbances or arrhythmia.
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 resynchronisation 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 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 Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
PR CONTACTS:
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St. Jude Medical
Marisa Bluestone
Media Relations
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mbluestoner ( @ ) sjm dot com
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