St. Jude Medical has gained European marketing approval for its Ellipse implantable cardioverter defibrillator (ICD), designed to treat potentially lethal, abnormally fast heart rhythms which often lead to sudden cardiac death (SCD).
Ellipse ICD features include expanded ShockGuard technology for protection against inappropriate and unnecessary therapy, high energy delivery, CorVue congestion monitoring and improved ST monitoring, to provide insight into ischemia-related ventricular arrhythmias.
CorVue congestion monitoring algorithm alerts physicians when a patient's heart failure may be worsening, evidenced by changes in electrical signals which can be correlated to increased congestion, or fluid retention, in the chest area.
In addition, Ellipse ICD incorporates SecureSense RV lead noise discrimination, a new algorithm that can differentiate lead noise from true ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes, providing the ability to automatically withhold tachycardia therapy in the presence of lead noise.
The angled header and rounded edges of the defibrillator improve the way a cardiac lead wraps around the device once connected, resulting in a smaller pocket for the device, according to the company.
L.R.C. Dekker, cardiologist at the Catharina Hospital in Eindhoven, the Netherlands, said the Ellipse ICD's longevity and new discrimination algorithms provide solutions for the three main concerns of patients and their doctors: decreasing the volume of the can, reducing the risk for infection during ICD replacement and minimising inappropriate shock.
St. Jude Medical Cardiac Rhythm Management Division president Eric Fain said the launch of the Ellipse family of ICDs further enhances the company's offering of cardiac rhythm management devices which, along with its Unify Quadra CRT-D system, represents the advanced portfolio of high voltage devices available in the industry.
Similar to the company's Fortify ICD, the Ellipse adheres to the International Standards Organization (ISO) DF4 connector specification, which reduces the number of connections between the defibrillation lead and the device, streamlining the implant procedure and patient comfort by reducing the bulk of wires in the patient's chest.