Forging on Amid Controversy, St. Jude Introduces ICD in Europe

Undeterred by its recent spate of defibrillator troubles, St. Jude Medical Inc. has received CE Mark approval in Europe for its Ellipse implantable cardioverter defibrillator (ICD).

ICDs are advanced implantable cardiac devices that treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardia or ventricular fibrillation) that often lead to sudden cardiac death (SCD).

The St. Paul, Minn.-based device behemoth has been plagued by a string of misfortune with several of its defibrillator leads in recent months, starting with the December recall of its Riata leads and an advisory letter earlier this year about the potential risks associated with its QuickSite and QuickFlex leads. Last month, the Heart Rhythm Journal published a study that concluded the company’s Riata leads to be the cause of 22 deaths due to faulty wiring. St. Jude has called upon the Journal to retract the study, citing inaccurate facts and bias.

The Ellipse was developed with the input of more than 200 physicians worldwide in focus groups set up by St. Jude. With their input, the device was designed with an angled header and rounded edges to improve the way in which cardiac leads wrap around the device once connected, resulting in a smaller space requirement in the body. The Ellipse ICD is similar to St. Jude’s Fortify ICD, and adheres to the International Standards Organization DF4 connector specification. The DF4 connector reduces the number of connections between the defibrillation lead and the device, which can streamline the implant procedure and improve patient comfort by reducing the bulk of wires in the patient’s chest. St. Jude Medical first began using DF4 technology in early 2009.

St. Jude’s existing technology is featured in a different way in its new device. The company’s ShockGuard technology for protection against inappropriate and unnecessary therapy is expanded in the Ellipse, and the resulting projected reduction in inappropriate therapy is 74 percent; the ICD also contains CorVue congestion monitoring, which alerts physicians when a patient’s heart failure may be worsening as evidenced by changes in electrical signals that can be correlated to increased congestion or fluid retention in the chest area. In addition,enhanced ST Monitoring in the device offers greater insight into ischemia-related ventricular arrhythmias by sending alerts to clinics about the heart’s condition, the company claims.

The device also features a new technology, the SecureSense RV lead noise discrimination, an algorithm that offers a set of lead monitoring capabilities. This means the device can differentiate between the noise from lead wires and the noise from true ventricular tachycardia or ventricular fibrillation episodes. Devices that do not have this capability run the risk of discharging treatment in the presence of lead noise, St. Jude executives contend.

St. Jude notes that this feature will help physicians proactively prevent lead wire complications, implicitly addressing possible concerns from consumers after the Riata lead fiasco.

St. Jude develops technologies for the treatment of heart conditions.