FDA Approves Only ICD with Ultra-High Energy on the First Shock

LAKE OSWEGO, Oregon, April 17, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that the Food and Drug Administration (FDA) has approved 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.

Two additional options of this unique defibrillator hybrid, the next generation BIOTRONIK DX systems, are now available to U.S. patients. They are:
•Inventra DX – the only such ICD system that can deliver ultra-high energy on the first shock; offering better protection to patients that depend on this life-saving therapy.
•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 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."

DX technology is based on more than a decade of engineering refinement to ensure accurate and reliable sensing and processing of the atrial signal. Due to its unique technology, the DX System has continued to drive BIOTRONIK’s U.S. customer adoption since it was initially introduced in February 2013.

It is the first defibrillator system equipped to provide dual-chamber diagnostic information with just one specialized defibrillator lead. Physicians 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 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.”

1. ^{Manufactured by BIOTRONIK SE & CO. KG}