Biotronik earns FDA approval for Acticor Sky, Rivacor Sky defibrillators

Biotronik announced today that it received FDA approval for its Acticor Sky and Rivacor implantable defibrillator systems.

Approval of the implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems extends the Germany-based company’s cardiac rhythm portfolio with novel technologies designed to support physiology-driven therapies and improve day-to-day clinical workflows.

Biotronik said the new Sky family of devices introduces solutions to address a broad range of clinical challenges. Those include left bundle branch area pacing (LBBAP). The system features a new anti-tachycardia pacing (ATP) suite to expand atrial and ventricular ATP options as well. It continues to offer Biotronik’s DX single-lead technology for atrial sensing without an additional atrial lead.

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