BIOTRONIK Announces First U.S. Implant of Acticor Sky CRT-DX New Device Family Delivers Physiologically Driven Therapies for Efficient, Patient-Centered Care
BIOTRONIK, a global leader in cardiovascular medical technology, today announced the first U.S. implant of its Acticor Sky DX cardiac resynchronization therapy defibrillator (CRT-D) system. This marks an important milestone following recent U.S. Food and Drug Administration (FDA) approval of its broader Acticor Sky and Rivacor Sky device family.
The procedure was successfully performed by Niraj Varma, MD, PhD, Electrophysiologist at Cleveland Clinic, and represents the first clinical use of Acticor Sky CRT-DX in the United States.
“In performing the first U.S. implant of this device, what stands out to me is how it supports physiologic pacing while integrating alerts for worsening heart failure”, said Dr. Varma, "This combination may have a real impact on how CRT-D therapy is delivered across the U.S.”
Acticor Sky CRT-DX is part of BIOTRONIK’s latest generation of implantable cardioverter-defibrillator (ICD) and CRT-D systems, designed to deliver physiologically driven therapy while simplifying clinical workflows across the care continuum. The platform supports left bundle branch area pacing workflows and autonomic nervous system heart rate modulation with CLS, enabling physicians to more easily implement physiologic pacing strategies in routine practice. And BIOTRONIK’s unique atrial sensing via DX Technology—a dual-lead CRT-D system with true atrial sensing—helps reduce procedure time and hardware burden.
The Acticor Sky and Rivacor Sky systems also offer technologies that provide physicians with earlier insights and more proactive care. HeartInsight delivers a consolidated, multi-parameter alert for worsening heart failure, enabling timely intervention, while MRI Guard 24/7 eliminates pre- and post-scan programming appointments.
“Acticor Sky represents an important step forward in our commitment to advancing physiologic therapy and simplifying care delivery,” said David Hayes, MD, Chief Medical Officer, BIOTRONIK. “By integrating technologies that support conduction system pacing, reduce system complexity, and streamline longitudinal care, Acticor Sky helps physicians deliver therapy that is better aligned with each patient’s individual needs.”
For more information about Acticor Sky, Rivacor Sky, and BIOTRONIK’s full portfolio, please visit www.biotronik.com.
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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.
