Biotronik and Medtronic cardiac rhythm devices added to PL

Cardiac rhythm management technologies from Biotronik and Medtronic are now available to privately insured patients following the inclusion of next-generation devices on the Prescribed List (PL).

Biotronik’s cardiovascular medical technology portfolio has expanded on the PL with the addition of its Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) systems. The listing strengthens Biotronik’s offering by introducing new technologies designed to support physiology-driven therapies while enhancing efficiency across clinical workflows.

The Sky family of devices has been developed to address a wide spectrum of contemporary clinical challenges, including left bundle branch area pacing (LBBAP). The systems incorporate an advanced anti-tachycardia pacing (ATP) suite, expanding atrial and ventricular ATP options, while continuing to feature Biotronik’s DX Technology, the only single-lead solution that provides true atrial sensing without requiring an additional atrial lead.

Acticor Sky and Rivacor Sky also integrate features aimed at improving clinical visibility and streamlining patient management. Biotronik’s HeartInsight technology delivers automatic, multi-parameter assessment of worsening heart failure through a single actionable alert, while MRI Guard 24/7 simplifies MRI access by removing the requirement for pre- and post-scan programming appointments, reducing wait times by up to 48%.

“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 at Biotronik.

In related news, Medtronic’s Micra AV2 transcatheter pacemaker system has also been added to the PL, extending access for privately insured patients requiring treatment for cardiac arrhythmias. The leadless pacemaker, which competes with Abbott’s Aveir VR system, offers a projected median battery life of 15.6 years, representing a 44% increase compared with the previous generation.

Leadless pacemakers represent a significant advancement in cardiac pacing technology, providing a minimally invasive alternative to conventional transvenous pacing systems. Implanted directly into the right ventricle via a delivery catheter inserted through the femoral vein, these devices eliminate the need for traditional pacing leads and surgical pockets, reducing exposure to infection risks and lead-related complications.

The Micra AV2 received TGA approval in 2024, but privately insured patients have faced a significant delay in gaining reimbursed access, with PL listing occurring only after a prolonged gap between regulatory approval and funding availability.

Both the Micra and Aveir VR leadless pacemaker systems support remote monitoring through patients’ cardiac clinics, enabling earlier identification of device performance concerns or emerging clinical issues while reducing reliance on routine in-person follow-up appointments.

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