The European Union has granted CE mark approval to St Jude Medical’s Assura family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds).
The portfolio, including Quadra Assura CRT-D, Unify Assura CRT-D and Fortify Assura ICD, features ShockGuard technology that protects the devices against inappropriate and unnecessary shocks.
Delivering 40J of energy, the devices also feature algorithms including SecureSense RV lead noise discrimination, which offers alerts and helps physicians to lower the risk of lead-related complications by automatically withholding tachycardia therapy in the presence of lead noise (an over-sensing of electrical signals).
In addition, Fortify Assura ICD also offers enhanced ST segment monitoring (which tracks electrical changes between heartbeats), through the Merlin.net Patient Care Network system, to indicate conditions such as ischemia.
The Merlin.net system provides patients timely information from home to clinics and helps in better managing arrhythmias.
The improvements are projected to reduce inappropriate therapy by 74%, allowing for more effective therapy, according to the company.
Heart and Diabetes Center North Rhine-Westphalia spokesperson Dr Klaus-Jürgen Gutleben said; "These devices offer unique features that I believe will help protect my patients from inappropriate shocks and provide greater defibrillation therapy assurance."
St. Jude Medical implantable electronic systems division president Dr Eric Fain said the company has completed its portfolio of cardiac rhythm management devices with the launch of the three new defibrillation technologies in Europe.
"The Assura line of devices was designed for safety, reliability and extended longevity to help physicians best treat their patients," Fain said.