FDA approval paves way for two Sorin Group launches
The Sorin Group launched its portfolio of pacing, defibrillation and left ventricular leads on May 10 after announcing that it received FDA approval. The announcement came on the heels of FDA approval and product launch for the international medical device company’s Paradym RF family of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds).
The Tilda pacing leads, Vigila defibrillation leads and Celerity left ventricular leads include multiple sizes and features to enable physicians to match their implant preferences with patient needs. The leads have a silicone lead body, steroid eluting tips that reduce inflammation, iridium fractal coated electrodes for electrical performance and features specific to each series.
Paradym RF family of ICDs and CRT-D devices are designed to be monitored remotely. The launch includes single-chamber Paradym RF VR, the dual-chamber Paradym RF DR and the Paradym RF CRT-D. The Paradym RF CRT-D and ICD devices deliver 37 Joules of energy with longevity over six years and nine years, respectively.
The Paradym RF CRT-D features a new programming option to electronically reprogram the device to avoid phrenic nerve stimulation, a common side effect of cardiac resynchronization therapy. In addition, Paradym RF CRT-Ds include Sorin’s Brady-Tachy Overlap algorithm that provides pacing therapy during exercise while maintaining the capability to detect and treat slow ventricular arrhythmias.
Sorin announced the FDA approvals and its product launches at the 33rd annual scientific sessions of the Heart Rhythm Society (HRS) in Boston.
The Tilda pacing leads, Vigila defibrillation leads and Celerity left ventricular leads include multiple sizes and features to enable physicians to match their implant preferences with patient needs. The leads have a silicone lead body, steroid eluting tips that reduce inflammation, iridium fractal coated electrodes for electrical performance and features specific to each series.
Paradym RF family of ICDs and CRT-D devices are designed to be monitored remotely. The launch includes single-chamber Paradym RF VR, the dual-chamber Paradym RF DR and the Paradym RF CRT-D. The Paradym RF CRT-D and ICD devices deliver 37 Joules of energy with longevity over six years and nine years, respectively.
The Paradym RF CRT-D features a new programming option to electronically reprogram the device to avoid phrenic nerve stimulation, a common side effect of cardiac resynchronization therapy. In addition, Paradym RF CRT-Ds include Sorin’s Brady-Tachy Overlap algorithm that provides pacing therapy during exercise while maintaining the capability to detect and treat slow ventricular arrhythmias.
Sorin announced the FDA approvals and its product launches at the 33rd annual scientific sessions of the Heart Rhythm Society (HRS) in Boston.