Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced today that the INTENSIA family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices received CE (Conformité Européenne) mark approval. This family of devices includes the single-chamber INTENSIA VR, the dual-chamber INTENSIA DR and the INTENSIA SonR® CRT-D devices, all of which feature a DF-4 high voltage connector.
The DF-4 connector design, the new industry standard for ICD and CRT-D devices, reduces the number of connections between the implanted device and the defibrillation (high voltage) lead from two to three to only one. Having only one connection port between the high voltage lead and the device facilitates the implant procedure since one set-screw is needed.
The new devices also feature Sorin's intelligent proprietary algorithms designed to improve CRT response, promote physiological pacing and minimize inappropriate shocks.
The INTENSIA SonR CRT-D with automatic CRT optimization enables heart failure patients to benefit from efficient resynchronization at rest and exercise. The clinically proven SonR™ algorithm has demonstrated a 23% improvement in CRT response. The SonRtip™ lead used with SonR devices features a unique hemodynamic sensor which measures the contractility of the left ventricle, allowing frequent and automatic optimization of device settings.
Furthermore, INTENSIA DR features the SafeR pacing mode which nearly eliminates unnecessary ventricular pacing and the PARAD+™arrhythmia discrimination algorithm which minimizes the number of inappropriate shocks3, thanks to a best-in-class 99% specificity.
The recent landmark OPTION study provides further evidence supporting the benefits of Sorin dual-chamber ICD therapy compared with single-chamber ICD therapy. Sorin dual-chamber ICDs delivered 58% fewer inappropriate shocks, compared with single-chamber devices at 2-year follow-up while avoiding the co-morbidity associated with excessive right ventricular pacing.
All INTENSIA devices are radio-frequency (RF)-enabled allowing convenient and efficient follow-up with the SMARTVIEW™ remote monitoring solution.
"In addition to the DF-4 high voltage connector, the INTENSIA family provides best-in-class therapy. The SonR algorithm automatically adjusts resynchronization settings and eliminates the time-consuming manual process that we previously used. The PARAD+ algorithm examines arrhythmias just like we would do and then applies the most appropriate therapy. INTENSIA devices provide us with confidence and peace of mind," said Dr. Frederic Anselme, Professor of Cardiology, University Hospital of Rouen, France.
"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," said Stefano Di Lullo, Sorin Group, President CRM Business Unit.