St. Jude Medical Gets Go Ahead for New Implantable Cardiac Devices

St. Jude Medical has received the European CE Mark of approval for the Fortify and Fortify ST implantable cardioverter defibrillators (ICD) and Unify cardiac resynchronization therapy defibrillator. The devices are smaller and can deliver a stronger punch than previous generation models, and they feature new heart monitoring algorithms.

These devices feature 40J of delivered energy (45J stored) – the highest energy level available in the industry – helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.
Because of the devices’ narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company’s SJ4 lead connector system further streamlines the procedure by reducing the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient’s chest.
The Unify CRT-D and Fortify ICD also incorporate the new CorVue(TM) pulmonary congestion monitoring algorithm. This new feature 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. The algorithm continuously monitors fluid retention in multiple vectors, providing an accurate diagnostic and an alert designed to minimize false positives.
Both devices also have features that are designed to assist in the reduction of unnecessary shocks, including painless anti-tachycardia pacing, which can be used for fast ventricular arrhythmias prior to or while the device is preparing to deliver shock therapy, and other enhanced technology for reducing inappropriate therapy.
In addition to the family-wide features of the Unify and Fortify devices, the Fortify ST ICD features St. Jude Medical’s first-to-market ST segment monitoring diagnostic algorithm, which can add important information to assist in medical decision making and accelerate patient care. The Fortify ST ICD continuously monitors for specific changes in the ST segment of the electrocardiogram that can indicate the onset of serious conditions such as ischemia.

Press release: St. Jude Medical Announces European Approval of Smaller, Higher Power ICD and CRT-D Devices with New Heart Failure Monitors