The US Food and Drug Administration (FDA) has approved Sorin Group's Paradym RF family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices.
The Paradym RF family of ICDs and CRT-D devices are designed for remote monitoring and uses company’s proprietary SafeR and Parad+ algorithms which automatically adjust to each individual patient to minimize right ventricular (RV) pacing and inappropriate shocks.
The Paradym RF CRT-D and ICD devices also utilize capacitor technology and deliver 37J of energy with longevity over six years and nine years respectively in an 11mm thin device.
The PARADYM RF CRT-D features a new programming option to electronically reprogram the device to avoid phrenic nerve stimulation and also includes the company’s brady-tachy overlap (BTO) algorithm that provides pacing therapy during exercise, while maintaining the ability to detect and treat slow ventricular arrhythmias.
Sorin Group CRM business unit president Stefano Di Lullo said, "The introduction of these new devices adds to Sorin’s growing portfolio of innovative implantable heart therapies designed to save lives and improve patient symptoms."