Paradym RF implantable cardiac defibrillators and cardiac resynchronisation therapy devices receive CE mark


Sorin Group announced, at Heart Rhythm 2011, the CE mark approval for the Paradym RF family of implantable cardiac defibrillators and cardiac resynchronisation therapy devices. With their proprietary algorithms, SafeR and Parad+, Paradym RF remote monitoring-enabled implantable cardiac defibrillators and cardiac resynchronisation therapy devices automatically adjust to provide individualised, appropriate therapy in a thin, powerful, long-lasting device.

The Paradym RF devices are designed to be monitored remotely with Sorin’s new, easy-to-use Smartview remote monitoring system. This system provides daily monitoring and scheduled remote follow-up of patients’ device status providing convenience and peace of mind to physicians and patients.

The Paradym devices are designed to provide patients with the optimal combination of thinness, high power and longevity. Utilising state-of-the-art battery and capacitor technology and an innovative remote monitoring design featuring high speed data transfer and monitor-initiated connection, these devices deliver 37J of energy with longevity over six years and nine years respectively in an 11mm thin device.

These implantable cardiac defibrillators and cardiac resynchronisation therapy devices include Sorin’s proprietary SafeR and Parad+ algorithms that automatically adjust to each individual patient to minimise right ventricular pacing and inappropriate shocks.

“Too many implantable cardiac defibrillators patients receive inappropriate shocks and unnecessary RV pacing resulting in decreased quality of life and increased mortality risk for patients, the Paradym devices are the only clinically proven implantable cardiac defibrillators that both reduce RV pacing below 1% and offer the lowest recorded inappropriate shock rate on the market to date,” said professor Brachmann from the Department of Cardiology at Klinikum Coburg, Germany, the first institution to implant the Paradym RF cardiac resynchronisation therapy device.

This cardiac resynchronisation therapy device also features a new programming option to electronically re-program the device to avoid phrenic nerve stimulation, a common side effect of resynchronisation therapy. In addition, this device includes Sorin’s exclusive Brady-Tachy Overlap (BTO) algorithm that provides pacing therapy during exercise while maintaining the ability to detect and treat slow ventricular arrhythmias. “We are impressed with the abilities of the new device” said professor Brachmann. “With BTO programming, we are able to encourage our heart failure patients to follow their cardiac rehabilitation program after cardiac resyncronisation therapy implant”.