Biotronik Announces FDA Approval of Acticor Sky and Rivacor Sky Defibrillators

BIOTRONIK has announced US Food and Drug Administration approval of its Acticor Sky and Rivacor Sky families of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), the German device maker's US arm said in an April 23 release.

ICDs are implanted devices that detect dangerous heart rhythms and deliver pacing or a shock to correct them. CRT-Ds add pacing that coordinates the heart's two lower chambers in people with heart failure.

Approved as PMA supplements in December

The FDA's premarket approval database shows that the agency approved the device families as supplements to three existing BIOTRONIK PMAs, covering its VR-T, DR-T and HF-T models. The record for the VR-T models, P980023/S136, lists the supplement as received on July 14, 2025, and decided on December 18, 2025, on the normal 180-day track. Its approval order statement reads: "approval for the Acticor/Rivacor Sky families of Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, as well as updated programmer software versions PSW 2503.U and NEO 2503.U."

Companion supplements P050023/S199 and P000009/S120 carry the same receipt and decision dates for the HF-T and DR-T models. The records list the reason as a change in design, components, specifications or material, and show that expedited review was not granted. A PMA supplement is used to approve changes to a device already approved through the FDA's premarket approval pathway, the route for high-risk devices.

The company's release did not say why it announced the approval about four months after the FDA's decision. It said the devices would be showcased at the Heart Rhythm Society's HRS 2026 meeting.

What the company says is new

BIOTRONIK said the Sky family supports left bundle branch area pacing, a form of conduction system pacing, and adds a new anti-tachycardia pacing suite that expands atrial and ventricular options. The devices keep the company's DX Technology, which it describes as the only single-lead solution that provides true atrial sensing without an extra atrial lead.

The company also pointed to a HeartInsight feature, which it said gives an automatic, multi-parameter alert for worsening heart failure, and MRI Guard 24/7, which it said removes the need for programming appointments before and after a scan. It said that feature can cut wait times by up to 48%, citing a 2025 conference abstract; that figure is company-cited and was not reviewed by Health Sense.

"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 David Hayes, BIOTRONIK's chief medical officer.

The release did not give pricing or say how many US centers would receive the devices first.