FDA clears St. Jude Ellipse cardioverter defibrillator

10 May 2012 (Last Updated May 10th, 2012 18:30)

St. Jude Medical's Ellipse implantable cardioverter defibrillator (ICD) has gained US Food and Drug Administration (FDA) approval for treating lethal, abnormally fast heart rhythms that often lead to sudden cardiac death (SCD).

Ellipse ICD

St. Jude Medical's Ellipse implantable cardioverter defibrillator (ICD) has gained US Food and Drug Administration (FDA) approval for treating lethal, abnormally fast heart rhythms that often lead to sudden cardiac death (SCD).

The angled header and rounded edges of the Ellipse ICD are designed to improve the way a lead wraps around the device once connected, resulting in a smaller incision and reduced pocket size for the device.

The implantable cardioverter defibrillator incorporates SecureSense RV lead noise discrimination, an algorithm that expands the company's ShockGuard technology, differentiating lead noise from true ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes requiring therapy.

The SecureSense RV technology will assist physicians by proactively lowering the risk of lead-related complications through its ability to automatically withhold tachycardia therapy in the presence of lead noise.

The Ellipse ICD is based on the International Standards Organization (ISO) DF4 connector specification, which results in a reduced number of connections between the defibrillation lead and the device.

"The St. Jude Medical Ellipse ICD will streamline the implant procedure and improve patient comfort."

Fullerton Cardiovascular Medical Group spokesperson Rahul Doshi said: "The St. Jude Medical Ellipse ICD not only will streamline the implant procedure and improve patient comfort with its innovative design, but the device adds safety features with its new discrimination algorithms intended to minimise inappropriate shocks."

St. Jude Medical cardiac rhythm management division's president, Eric Fain, said: "With the launch of the Ellipse ICD and the Assura family of implantable defibrillators, St. Jude Medical is able to provide physicians with a complete portfolio of devices that meet the individualised needs of patients and our customers' needs for reliable, efficient technologies."

The company has four major focus areas including cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.


Image: The Ellipse implantable cardioverter defibrillator from St. Jude Medical is now available in the US. Photo courtesy of: St. Jude Medical.