St Jude Medical has obtained CE mark approval for its Assura family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
The portfolio includes Quadra Assura CRT-D, Unify Assura CRT-D and Fortify Assura ICD, which feature ShockGuard technology designed to protect the devices against inappropriate and unnecessary shocks.
The devices deliver 40 Joules of energyand include 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 which provides patients timely information from home to clinics and helps in better managing arrhythmias.
St. Jude Medical implantable electronic systems division president Eric Fain said the company has completed its portfolio of cardiac rhythm management devices with the launch of 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 added.