FDA Approves BIOTRONIK’s Acticor Sky, Rivacor Sky ICD and CRT-D Systems

BIOTRONIK has earned U.S. Food and Drug Administration (FDA) approval for its Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The authorization expands BIOTRONIK’s cardiac rhythm portfolio with technologies that support physiology-driven therapies and improve daily clinical workflows.

The new Sky family of devices introduces solutions for a broad range of clinical challenges, including Left Bundle Branch Area Pacing (LBBAP). It features a new anti-tachycardia pacing (ATP) suite to expand atrial and ventricular ATP options, and continues to offer BIOTRONIK’s DX Technology, the only single-lead solution providing true atrial sensing without an additional atrial lead.

Acticor Sky and Rivacor Sky also include technologies designed to deliver clearer insights and more efficient workflows. BIOTRONIK’s new HeartInsight feature provides automatic, multi-parameter insight into worsening heart failure through a single actionable alert, while MRI Guard 24/7 streamlines MRI access by eliminating the need for pre- and post-scan programming appointments^1,2—reducing wait times by up to 48%.³

“Acticor Sky and Rivacor Sky bring together what care teams have been asking for: therapy options that closely follow cardiac physiology and features that support daily workflows,” BIOTRONIK Chief Medical Officer Dr. David Hayes said. “We are excited to bring these technologies to more of our physician customers and their patients.”

For more than 60 years, BIOTRONIK has pioneered innovations that have transformed the lives of those affected by heart disease and chronic pain. The company engineers therapies through its advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing solutions in Electrophysiology. It created Germany’s first pacemaker in 1963 and broke new ground in digital technologies and conduction system pacing today. BIOTRONIK is headquartered in Berlin, and its global reach spans more than 100 countries across the Americas, EMEA, and Asia.

References
¹ Mullane S, et al. Heart Rhythm O2. 2021 Mar 9; 2(2)
² Data on file
³ Basquill O et al. Europace. 2025 May; 27(Suppl 1)