Italian Cardiovascular device maker Sorin Group has gained CE Mark approval for its INTENSIA family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices. 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.
Background
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 or 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.
Sorin says its INTENSIA SonR CRT-D with automatic CRT optimization enables heart failure patients to benefit from efficient resynchronization at rest and exercise. It cites clinical support for its SonR™ algorithm, which the company says 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.
The dual chamber 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 shocks, thanks to a claimed best-in-class 99% specificity.
Physician comments
“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.
Company comments
“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
Source: Sorin Group, SpA., Business Wire
published: December 9, 2013 in: Approval/Clearance, Cardio, Sorin