FDA approves implantable cardioverter defibrillator with ultra-high energy on the first shock



The Food and Drug Administration (FDA) has approved Biotronik’s implantable cardioverter defibrillator that can deliver ultra-high energy on the first shock. Also included in the approval response from the FDA is the latest generation of defibrillator devices for patients with complex heart rhythm conditions.

Two additional options of this defibrillator hybrid, the next generation Biotronik DX systems, are now available to US patients. They are:

  • Inventra DX-the “only such implantable cardioverter defibrillator system that can deliver ultra-high energy on the first shock”, offering better protection to patients that depend on this treatment.
  • Itrevia DX-a less invasive therapy with an algorithm that can identify successful pain-free therapies for each patient and dynamically re-apply them as needed. The complete Itrevia family-including Itrevia VR-T, Itrevia DR-T, and Itrevia HF-T-were approved together.

“Most physicians already understand the benefit of having an implantable cardioverter defibrillator that can deliver dual-chamber diagnostics with a single lead,” says James E Stone Jr, Cardiology Associates of North Mississippi in Tupelo, USA.

“DX systems use single coil leads, and these leads are definitely my preference because evidence shows lower long-term complication rates,” says Stone. “In rare cases, patients will present with high defibrillation thresholds that require maximum energy. Biotronik’s Inventra DX will be a good alternative for these patients.”

DX is the first defibrillator system equipped to provide dual-chamber diagnostic information with just one specialised defibrillator lead. Biotronik says that surgeons consider the DX system a solution to the limited capabilities of single chamber devices, and several potential complications associated with dual chamber devices.

“Physician experts in the field of electrophysiology have indicated that meaningful therapeutic innovations available in Itrevia and Inventra implantable cardioverter defibrillators-like high energy options, DX systems and CLS-make it easier for physicians to tailor therapy and improve the quality of life for their patients,” says Marlou Janssen, president, Biotronik.