First Implant of S-ICD System Implantable Defibrillator at Manatee Memorial Hospital Performed

Bradenton, FL, February 20, 2014 — Patients can now get the same protection from sudden cardiac arrest as they would get with a defibrillator but through a less invasive procedure that does not touch their heart and blood vessels, thanks to the world's first and only commercially available subcutaneous implantable defibrillator (S-ICD) that is now is available at Manatee Memorial Hospital.

On February 19, Manatee Memorial Hospital became first hospital in Manatee and Sarasota Counties to implant the Boston Scientific S-ICD® System in a patient. The implantation was performed by Joseph Pace, MD, in Manatee Memorial’s Heart and Vascular Center’s Hybrid Catheterization Lab.

The entire S-ICD System sits just below the patient's skin without the need for physicians to place thin, insulated wires – known as leads – into the patient's heart, as is done with conventional defibrillators.

“This is a less invasive procedure with fewer short- and long-term complications. It functions as well as, if not better than current technology and is usually more tolerable,” Dr. Pace said after the procedure.

Sudden cardiac arrest is an abrupt loss of heart function. Most episodes are caused by the rapid and/or chaotic activity of the heart known as ventricular tachycardia or ventricular fibrillation. Recent estimates show that approximately 850,000 people in the United States are at risk of SCA and indicated for an ICD device, but remain unprotected.

The S-ICD System has two main components: (1) the pulse generator, which powers the system, monitors heart activity, and delivers a shock if needed, and (2) the electrode, which enables the device to sense the cardiac rhythm and serves as a pathway for shock delivery when necessary. Both components are implanted just under the skin—the generator at the side of the chest, and the electrode beside the breastbone. Implantation with the S-ICD System is straightforward and can be done using only anatomical landmarks which removes the need for fluoroscopy (an X-ray procedure that is required for standard leads to be placed in the heart).

The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.

The U.S. Food and Drug Administration granted regulatory approval for the S-ICD System in September 2012. The S-ICD System received CE Mark in 2009 and is commercially available in many countries in Europe and in New Zealand. To date, more than 2,000 devices have been implanted in patients around the world.

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Manatee Memorial Hospital is owned and operated by a subsidiary of Universal Health Services, Inc. (UHS), a King of Prussia, PA-based company, that is one of the largest healthcare management companies in the nation.      

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