BIOTRONIK Launches of ‘World’s First’ CRT-D Systems Approved for Conduction System Pacing
•February 17, 2026
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Why It Matters
The launch validates LBBAP as a mainstream, high‑voltage therapy, promising better patient outcomes and reshaping the cardiac device market.
Key Takeaways
- •First CE‑approved LBBAP high‑voltage CRT‑D
- •Streamlined programming accelerates implantation workflow
- •Dual‑lead CRT‑DX reduces procedure complexity
- •Closed‑Loop Stimulation mimics natural cardiac demand
- •MRI Guard 24/7 enables automatic full‑body MRI access
Pulse Analysis
Conduction system pacing (CSP) has moved from experimental to essential as clinicians seek more physiologic alternatives to traditional right‑ventricular pacing. By securing the first CE‑approval for a high‑voltage device that supports left bundle branch area pacing, BIOTRONIK bridges a critical gap, allowing electrophysiologists to deliver resynchronisation therapy with a pacing vector that mirrors natural cardiac activation. This regulatory milestone not only legitimises LBBAP in Europe but also sets a benchmark for future device submissions worldwide.
The Acticor Sky and Rivacor Sky platforms embed several innovations that streamline both implantation and long‑term management. Dedicated LBBAP programming and Closed‑Loop Stimulation (CLS) automatically adjust output to real‑time cardiac demand, while the DX atrial‑sensing technology enhances early atrial fibrillation detection and discrimination. An integrated anti‑tachycardia pacing suite combines atrial and ventricular ATP, reducing shock burden and improving quality of life. Additionally, MRI Guard 24/7 provides seamless, full‑body MRI access without pre‑scan reprogramming, cutting down patient touchpoints and procedural overhead.
From a market perspective, the devices position BIOTRONIK at the forefront of the emerging CSP segment, challenging incumbents still focused on conventional CRT‑D solutions. Hospitals adopting the Sky family can expect shorter procedure times, lower complication rates, and expanded therapeutic options for complex rhythm disorders. As guideline committees increasingly recognize LBBAP’s benefits, reimbursement pathways are likely to evolve, accelerating adoption across Europe and potentially influencing U.S. regulatory strategies. The launch therefore signals a shift toward more physiologic, patient‑centric cardiac care and underscores the commercial upside of integrating advanced pacing algorithms with workflow‑friendly design.
BIOTRONIK launches of ‘World’s First’ CRT-D systems approved for conduction system pacing
BIOTRONIK launches new Acticor Sky and Rivacor Sky device family featuring the world’s first CE‑approved left bundle branch area pacing (LBBAP) high‑voltage device
The new Acticor Sky and Rivacor Sky device family, comprising next‑generation implantable cardioverter‑defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT‑Ds), is now available across CE markets.
The first European commercial implant was performed at University Hospital Frankfurt by Dr. Anastasia Falagkari and Prof. Dr. Reza Wakili. The team implanted the CRT‑D device Rivacor Sky HF‑T in an 87‑year‑old patient with ischemic cardiomyopathy requiring an ICD, a history of atrial fibrillation, and an expected high ventricular pacing rate.
“The device’s streamlined programming and diagnostics were immediately noticeable,” said Dr. Falagkari, Senior Attending Physician for Electrophysiology. “Pacing in the left bundle branch area provides more physiologic and synchronised heart contractions, which is exactly what we aim for in resynchronisation therapy. The CRT‑DX technology allows a dual‑lead CRT approach, contributing to a more efficient implantation procedure. In addition, based on the two‑lead‑only approach it is very likely to reduce also complication risk in the future.”
Key features of the new devices include:
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Physiological Pacing Options: Dedicated programming and streamlined workflows for LBBAP make implementation fast and intuitive. Closed Loop Stimulation (CLS) offers a uniquely physiologic pacing option, continuously responding to real cardiac demand beyond conventional rate‑response systems.
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Enhanced Arrhythmia Management: Smart atrial fibrillation detection and discrimination via BIOTRONIK’s unique DX technology enables early intervention.
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Optimised Therapy Delivery: BIOTRONIK’s unique anti‑tachycardia pacing (ATP) suite combines atrial and ventricular ATP to reduce atrial arrhythmias as well as shock burden, improving patients’ quality of life.
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Workflow Efficiency: MRI Guard 24/7 delivers full‑body MRI access automatically, eliminating pre‑ and post‑scan programming to reduce touchpoints needed with the patient.
“With Acticor and Rivacor Sky, we created a platform that elevates cardiac care,” said Dr. Andreas Hecker, Chief Technology Officer at BIOTRONIK. “This new device family combines proven reliability with advanced algorithms to tailor therapy more precisely while simplifying workflows that support physicians in their daily work.”
Prof. Reza Wakili, Deputy Director of Cardiology at University Hospital Frankfurt added: “Combining physiological pacing capabilities with enhanced DX atrial sensing in a single platform gives us practical advantages in daily clinical decision‑making. It allows us to identify arrhythmias earlier and tailor therapy pathways more accurately, which is essential when managing patients with complex rhythm disorders.”
With conduction system pacing (CSP) gaining recognition as a more physiological pacing strategy, healthcare teams are increasingly relying on systems that support LBBAP workflows without adding procedural complexity. Acticor Sky and Rivacor Sky represent a significant advancement in this field as the world’s first fully approved LBBAP‑capable high‑voltage devices.
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