Sorin Group (BIT:SRN) said its Intensia line of implantable cardioverter defibrillators and cardiac resynchronization therapy devices won CE Mark approval in the European Union.
The Invasio line includes the single-chamber Intensia VR, the dual-chamber Intensia DR and the Intensia SonR CRT-D devices. All the devices feature a DF-4 high-voltage connector and are radio-frequency enabled.
The Intensia DR specifically features the SafeR pacing mode, which “nearly eliminates unnecessary ventricular pacing” and the Parad+ arrhythmia discrimination algorithm, which cuts down on the number of inappropriate shocks, according to a press release.
“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,” Dr. Frederic Anselme of University Hospital of Rouen, France, said in prepared remarks.
Milan-based Sorin is on a regulatory roll, with CE Mark approval in the European Union for its Kora 100 DR and SR pacemakers coming earlier this week. Last month the Italian medtech maker reported CE Marks for its Solo Smart stentless aortic valve and for the XL version of its Perceval sutureless aortic valve.
