St. Jude Medical announced receiving European CE Mark approval for its Assura implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). This line of devices feature the company’s proprietary ShockGuard technology which works to prevent unnecessary shocks, while delivering the maximum available 40 Joules when appropriate.
The Quadra Assura CRT-D utilizes four electrodes on its leads, offering greater flexibility and reducing complications thanks to better signal collection and improved energy delivery. The Unify Assura CRT-D is the smallest implant available of its type, while the Fortify Assura ICD performs ST monitoring and is the most powerful implanted defibrillator available.
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, CorVue™ congestion 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 (which tracks electrical changes between heartbeats). Monitoring of the ST segment helps indicate conditions such as ischemia, which happens when blood flow and oxygen to the heart muscle is obstructed. ST segment monitoring in an ICD prior to therapy for ventricular arrhythmias can offer greater insight into the cause of these dangerous heart rhythms.
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 – Keeping the well-received shape of previous generations of Unify™ devices, the Unifiy Assura CRT-D has the smallest footprint in the industry for reduced incision size.
Fortify Assura ICD – Offering enhanced ST monitoring, the Fortify Assura ICD also has the highest delivered energy of any ICD available.