St. Jude's Assura ICD, CRT-Ds net EU approval

St. Jude Medical has received European CE Mark approval for the Assura portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

The Assura family of devices, featuring Shockguard technology, has three new algorithms that seek to reduce inappropriate shocks, according to St. Jude. Assura devices can produce 40 Joules of energy. The devices include CorVue congestion monitoring and algorithms including SecureSense RV lead noise discrimination, which offers physicians alerts to reduce lead-related complications by withholding tachycardia therapy in the presence of lead noise, the St. Paul, Minn.-based company said.

The three new Assura devices available in Europe are:

  • Quadra Assura CRT-D: Featuring quadripolar pacing technology from St. Jude, the Quadra Assura CRT-D is designed to address common pacing complications such as phrenic nerve stimulation and high pacing thresholds;
  • Unify Assura CRT-D: The Unifiy Assura CRT-D has kept the shape of the previous generations of Unify devices; and
  • Fortify Assura ICD: The Fortify Assura ICD offers ST segment monitoring, which can help indicate conditions such as ischemia.

The Assura family of devices allows for expanded ST segment monitoring through the Patient Care Network, a system that lets patients be monitored from home. This system provides information to clinics.