FDA Approval for Only ICD to Deliver Ultra-High Energy on First Shock

Cardiovascular technology company Biotronik, has gained U.S. FDA approval for its what is the only implantable cardioverter defibrillator (ICD) 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.

Background

The FDA approval covers two Biotronik DX defibrillator hybrid devices including the Inventra DX, which is the only such ICD system that can deliver ultra-high energy on the first shock, and the 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 approval includes the complete Itrevia family, which includes the Itrevia VR-T, Itrevia DR-T, and Itrevia HF-T.

Based on more than a decade of engineering refinement to ensure accurate and reliable sensing and processing of the atrial signal, DX technology is the first defibrillator system equipped to provide dual-chamber diagnostic information with just one specialized defibrillator lead. This is designed to reduce risks associated with additional hardware for patients while providing valuable clinical information to the physician.

Physician comments

“Most physicians already understand the benefit of having an ICD that can deliver dual-chamber diagnostics with a single lead,” said Dr. James E. Stone, Jr., Cardiology Associates of North Mississippi in Tupelo, MS.

“DX systems use single coil leads, and these leads are definitely my preference because evidence shows lower long-term complication rates,” said Dr. 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.”

Company comments 

“Physician experts in the field of electrophysiology have indicated that meaningful therapeutic innovations available in Itrevia and Inventra ICDs ‑ 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,” said Marlou Janssen, President, BIOTRONIK, Inc. “This approval is yet another example of BIOTRONIK’s ability to offer unique stand-alone technology to support electrophysiologists as they pursue their life-saving, life-changing work for patients.”

Source: Biotronik, Inc.

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