Beebe Healthcare among first in the nation to use new FDA-approved implantable device to treat sudden cardiac arrest

Beebe Healthcare is the first on Delmarva and among the first in the nation to offer patients the newly FDA-approved implantable cardioverter defibrillator (ICD) system that can be used with magnetic resonance imaging (MRI) scans.

Many people have ICDs implanted in their chests to detect and correct irregular heartbeats.  The problem for these patients has been that ICDs prevent them from being able to have MRI scans because of the potential interactions between the two technologies. Studies have shown that within four years, more than one-third of patients with ICDs will need an MRI, and not be able to have one. 

On September 14, 2015, the U.S. Food and Drug Administration (FDA) approved the new Evera MRI™ SureScan® ICD System made by Medtronic now being used at Beebe Healthcare.

“We are extremely proud to be able to offer this advanced technology in heart care to our patients,” said Jeffrey M. Fried, FACHE, President and CEO of Beebe Healthcare. “It represents the ongoing commitment of our team to continually improve the care that we provide. We also are pleased that we have a cardiologist at Beebe, Dr. Firas El-Sabbagh, who has the expertise to implant this new, life-saving device when it is needed.”

Dr. El-Sabbagh is Board Certified in Cardiology and in Electrophysiology, which is the cardiology specialty that deals with the electrical system of the heart.  He also is Fellowship-trained in Cardiovascular Disease. Dr. El-Sabbagh has already implanted the new device in a patient at Beebe.

An ICD is a small implantable heart device that is placed under the skin typically just below the collarbone on the left side of the chest. For patients at risk for a life-threatening cardiac arrhythmia or sudden cardiac arrest, which can result in death if the patient is not treated within minutes, ICDs may be prescribed to continuously monitor heart rate and deliver an electrical signal to correct a life-threatening heart rate, if detected. 

MRI is an imaging test used regularly for a wide range of diagnoses including conditions such as stroke, cancer, Alzheimer’s disease, and muscle, bone and back pain.

The Evera MRI™ SureScan® ICD System is approved to allow for MRI scans on any part of the body. The system includes design enhancements from previous generation devices that allow it to safely undergo full-body MRIs, while maintaining the same longevity, proven shock reduction and physical size and shape of the original Evera ICD. The device is paired with the Sprint Quattro® Secure MRI SureScan® DF4 leads, backed by more than 10 years of proven performance with active monitoring,  now tested for safe use during an MRI.

The FDA approval of the Evera MRI ICD system was based on safety and efficacy data from the randomized, controlled Evera MRI Clinical Trial that demonstrated that the Evera MRI ICD system is safe and effective, and that full-body MRI scans did not affect its ability to deliver life-saving therapy. 

“Our leadership at Beebe is truly supportive of the efforts of our Medical Staff to provide our patients with the latest in safe, evidence-based treatments,” says Lynn Amey, Executive Director of Cardiac and Vascular Services at Beebe Healthcare.  “This ICD device is an excellent example of how quickly our organization can move to bring a life-saving technology to the communities that we serve.”

Beebe Healthcare is a not-for-profit community healthcare system with a charitable mission to encourage healthy living, prevent illness, and restore optimal health for the people residing, working, or visiting in the communities we serve. It offers services throughout Southern Delaware for residents and visitors, including a 210-licensed-bed hospital, a cancer center, and outpatient facilities providing walk-in care, lab, imaging, and physical rehab services.  For more information, please visit us online at www.beebehealthcare.org.