Sorin obtains CE Mark approval for Intensia family of ICD and CRT-D devices

8 December 2013 (Last Updated December 8th, 2013 18:30)

Italy-based medical device company Sorin has obtained CE Mark approval for Intensia family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT-D) devices.

Intensia

Italy-based medical device company Sorin has obtained CE Mark approval for Intensia family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT-D) devices.

The Intensia family includes single-chamber Intensia VR, dual-chamber Intensia DR and Intensia SonR CRT-D devices.

All of these Intensia devices feature a DF-4 high-voltage connector that reduces the number of connections between the implanted device and the defibrillation (high-voltage) lead to only one from two to three.

Incorporating Sorin's intelligent proprietary algorithms, these new devices improve cardiac resynchronisation therapy (CRT) response, promote physiological pacing and minimise inappropriate shocks.

According to Sorin, the Intensia SonR CRT-D with automatic CRT optimisation allows heart failure patients to benefit from efficient resynchronisation at rest and exercise.

Based on the patient's heart activity and needs, the SonR algorithm automatically adjusts the resynchronisation settings and eliminates the time-consuming manual process. This algorithm has showed 23% improvement in CRT response.

SonR devices feature a SonRtip lead with haemodynamic sensor that measures the contractility of the left ventricle.

"SonR devices feature a SonRtip lead with haemodynamic sensor that measures the contractility of the left ventricle."

The SafeR pacing mode of Intensia DR nearly eliminates unnecessary ventricular pacing and the PARAD+ arrhythmia discrimination algorithm minimises the number of inappropriate shocks.

Recently, Sorin has announced findings from the landmark OPTION study demonstrating that patients with Sorin dual-chamber ICDs experienced a significantly lower incidence of inappropriate shocks compared with patients with standard single-chamber devices. The median follow-up was over two years.

In addition, Sorin dual-chamber ICDs minimised the co-morbidity associated with excessive right ventricular pacing.

The radio-frequency enabled Intensia devices also allow convenient and efficient follow-up with the Smartview remote monitoring solution.

Sorin CRM business unit president Stefano Di Lullo said: "We are committed to continuing technological improvements across our entire line of cardiac rhythm devices to improve patients' lives and enable physicians to provide even better patient care in the changing healthcare landscape."


Image: Sorin launches its Intensia range of ICD and CRT-D devices. Photo: courtesy of Sorin.