Assura implantable defibrillators get the CE mark approval


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

The Assura family of devices, featuring Shockguard technology has three new algorithms that help protect patients against inappropriate shocks while providing the highest amount of delivered energy. The company states that these improvements are projected to reduce inappropriate therapy by 74%, allowing for more effective therapy. Products currently available in Europe include the Quadra Assura CRT-D, Unify Assura CRT-D and Fortify Assura ICD.

All Assura devices can produce 40 Joules (J) of energy – the highest delivered energy available. The devices include expanded ShockGuard technology for protection against inappropriate and unnecessary shocks, CorVuecongestion monitoring and algorithms including SecureSense RV lead noise discrimination, which offers physicians advanced alerts and helps proactively lower the risk of lead-related complications by automatically withholding tachycardia therapy in the presence of lead noise (an over-sensing of electrical signals).

The Fortify Assura device also offers enhanced ST segment monitoring.

“With the three new discriminators and highest amount of delivered energy, the Assura devices provide the ideal combination of intelligence and strength. These devices offer unique features that I believe will help protect my patients from inappropriate shocks and provide greater defibrillation therapy assurance,” said Klaus-Jürgen Gutleben, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany.

The three new Assura devices available in Europe are:

  • Quadra Assura CRT-D: Featuring first-to-market quadripolar pacing technology from St Jude Medical, the Quadra Assura CRT-D is designed to address common pacing complications such as phrenic nerve stimulation and high pacing thresholds, which can result in fewer surgical revisions, shorter procedure times and decreased fluoroscopic exposure.
  • Unify Assura CRT-D: the device has the smallest footprint in the industry for reduced incision size.
  • Fortify Assura IC : Offering enhanced ST monitoring, the Fortify Assura ICD also has the highest delivered energy of any ICD available.

While the majority of shocks delivered by ICDs and CRT-Ds are considered appropriate and life-saving, the expanded ShockGuard technology, included in all CE mark approved Assura products, provides more accurate sensing and can differentiate between rhythms that require defibrillation and those that do not. The new algorithms and enhanced detection capabilities discriminate between lead noise and arrhythmias that require therapy, as well as which heart chamber is causing the arrhythmia. The new algorithms also detect and alert to episodes of oversensing due to lead noise and distinguish small electrical disruptions from real episodes that warrant life-saving treatment.

The Assura family of devices allows for expanded ST segment monitoring through the Patient Care Network, a system that allows patients to be monitored from home. This system provides timely information to clinics and ultimately allows for better management of patients with arrhythmias.

Across Europe, sudden cardiac death is estimated to affect between 180,000 and 450,000 people annually, according to meta-analysis conducted by the Sudden Cardiac Arrest Thought Leadership Alliance (SCATLA).