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Home News News Archives 2012 Archive FDA Approves Boston Scientific's Heart Device

FDA Approves Boston Scientific's Heart Device 

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Sentara Cardiovascular Research Institute among top enrolling sites in national study giving new options to patients at risk of sudden cardiac arrest.

Sentara Cardiovascular Research Institute

Hampton Roads, VA (October 2, 2012) Sentara Cardiovascular Research Institute was among the top enrolling heart centers in the country involved in the S-ICD® System Clinical Investigation study sponsored by Cameron Health, which is now part of Boston Scientific.

The purpose of the study was to test the safety and efficacy of a small device, known as S-ICD or subcutaneous implantable cardioverter defibrillator. The device is being used to re-start the heart in patients with potentially fatal irregular heart beats.

Unlike earlier implantable cardiac defibrillators, leads of the S-ICD do not touch the heart. They are placed over the heart.

An FDA advisory panel recommended the device for approval April 26, 2012, and it’s anticipated the FDA will approve this new S-ICD in the future for patients who have survived a cardiac arrest or are at risk of sudden cardiac arrest, a condition where the electrical impulses of the heart misfire causing the heart to quiver instead of pump blood needed throughout the body.

About the Study

Exactly 19 patients from Hampton Roads, Virginia have been enrolled by researchers with Sentara Cardiovascular Research Institute the last two years in the 330-patient pivotal study. All are doing well with the study device.

For years, implantable cardioverter defibrillators (ICDs) have been the only option for these patients. The earlier devices were placed under the skin with wires going through veins to connect directly to the heart. When the heart misfires, electrical shocks from the ICD help kick start the heart again.

The S-ICD® System Clinical Investigation sponsored by Cameron Health tested a new device without wires going directly to the heart. This new device is placed under the skin with wires that follow the breast bone outside of the chest cavity and are positioned just over the heart. Without wires traveling through veins in this modified design, it could be offered to more patients.

The new design of this device offers the possibility for fewer complications and may be applicable to a broader group of patients. Our hope as researchers is that this new device will be more attractive to physicians and their patients who are at risk of Sudden Cardiac Arrest (SCA),” says cardiologist John M. Herre, MD, the Sentara principal investigator for the study.

It's estimated about 850,000 people in the U.S. are at risk of sudden cardiac arrest  while only about 35 percent of patients who are at risk actually receive an ICD.

As a high enrolling site, Sentara Cardiovascular Research Institute’s conduct of the study was audited by the FDA. The review resulted in confirmation of SCRI’s careful enrollment process and conduct of the study.

About Sentara Cardiovascular Research Institute

Sentara Cardiovascular Research Institute is part of Sentara Healthcare, one of the nation’s leading not-for-profit health systems and an acknowledged leader in patient safety and quality innovation. The Sentara Cardiovascular Research Institute grew out of a long history of providing exceptional heart care at Sentara. Established in 2005, the Sentara Cardiovascular and Research Institute is now among the top cardiac research programs in the country, with about 70 ongoing studies per year.

Related Links:
Sentara Heart
Sentara Cardiovascular Research Institute

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