Medtronic Introduces Implantable Defibrillators in U.S.
Jun 30, 2005
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Medtronic, Inc. announced the U.S. introduction of the Medtronic EnTrust(TM) implantable cardioverter-defibrillator (ICD). The EnTrust single- and dual-chamber devices expand the company's premium line of industry-leading defibrillators, which are designed to treat patients with abnormally fast and potentially life-threatening heartbeats (ventricular tachycardia or VT) that can lead to sudden cardiac arrest (SCA). The EnTrust ICD family was approved by the U.S. Food and Drug Administration on June 14, 2005.
The EnTrust family of devices challenges the notion that ICDs must deliver a shock to stop a dangerous heart rhythm. EnTrust is the first ICD to offer ATP During Charging(TM), a feature that automatically uses pacing pulses to painlessly stop fast, dangerous heartbeats, while concurrently preparing to deliver a shock if needed, with no delay.
Recent clinical studies have shown that 90 percent of fast heart rhythms have the potential to be terminated by pacing alone. The use of this painless anti-tachycardia pacing (ATP) to stop fast heartbeats has been clinically proven to eliminate three out of four shocks with painless therapy.
"An ICD can be an absolute lifesaver for its recipient, yet the possibility of a shock always hovers over the patient," said David M. Steinhaus, M.D., executive medical director of the St. Luke's Mid America Heart Institute, Kansas City, MO, U.S. "The ATP During Charging feature offers patients the comfort of painlessly terminating dangerous ventricular heart rhythms, and the experience of fewer unnecessary shocks. Yet if a patient should need a shock, there is no delay in therapy."
In addition, the EnTrust dual-chamber ICD helps reduce inappropriate therapy by better identifying episodes of supraventricular tachycardia (SVT), which may ensure that patients receive appropriate shocks.
The dual-chamber version also incorporates a pacing mode called MVP(TM), or Managed Ventricular Pacing, which reportedly promotes natural heart activity by significantly reducing unnecessary pacing in the heart's lower right chamber (ventricle). According to the company, this algorithm can reduce the amount of ventricular pacing to a median of 0.1 percent, compared to 50 percent or more with typical dual-chamber ICDs. This provides an important patient benefit since previous studies have shown that unnecessary pacing in the right ventricle can increase the risk for heart failure and atrial fibrillation. Reportedly, ICDs have been proven to be 98 percent effective in treating the rapid rhythms that can lead to sudden cardiac arrest.
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