The European Union has granted a CE mark of approval for St. Jude Medical’s Fortify ST implantable cardioverter defibrillator (ICD) and its Unify cardiac resynchronization therapy-defibrillator (CRT-D) for distribution throughout Europe.
The devices are indicated for use in heart failure patients and those who are at risk for sudden cardiac arrest. Their reduced size allows for less significant incisions and increased device longevity due to a higher energy capacity of 40J, according to the St. Paul, Minn.-based company.
St. Jude said the devices are most functional in patients who exhibit an enlarged heart, a low ejection fraction and advanced heart failure of those who demonstrated a high defibrillation threshold (energy required to revert the heart back to normal rhythm). In addition, the devices’ SJ4 lead connector system shrinks the amount of connections between the defibrillation lead and the device.
According to the company, the devices are equipped with a pulmonary congestion monitoring algorithm, CorVue, that alerts physicians when a patient’s serious conditions worsen, such as ischemia. CorVue allows for the continuous monitoring of fluid retention and also provides an alert system that helps to reduce false positives.
The Unify and Fortify devices are still awaiting approval for use by the FDA.