LAKE OSWEGO, Oregon, USA

BIOTRONIK Announces FDA Approval for Acticor Sky and Rivacor Sky ICD and CRT-D Systems

  • Next-generation device family offers physiology-driven therapies and streamlined workflows across care teams
  • Product will be showcased at HRS 2026

BIOTRONIK, a global leader in cardiovascular medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The approval expands BIOTRONIK’s cardiac rhythm portfolio with novel technologies designed to support physiology-driven therapies and improve day-to-day clinical workflows.

The new Sky family of devices introduces solutions that address 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 unique 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 appointments1,2—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,” said Dr. David Hayes, Chief Medical Officer, BIOTRONIK. “We are excited to bring these technologies to more of our physician customers and their patients.”

With Acticor Sky and Rivacor Sky, BIOTRONIK continues to focus on clinically relevant innovation, reliability, and patient-centered design to support physicians in cardiac rhythm management.

For more information about Acticor Sky, Rivacor Sky, and BIOTRONIK’s full portfolio, please visit www.biotronik.com.

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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)

 

About BIOTRONIK

For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonize technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.