Technology | April 27, 2015

FDA Approves Biotronik ICD with Ultra-High Energy on First Shock

Inventra and Itrevia hybrid defibrillators offer dual-chamber diagnostics with single lead

Biotronik, DX, ICD, Inventra, Itrevia, FDA, ultra-high energy

April 27, 2015 — Biotronik announced that the U.S. Food and Drug Administration (FDA) has approved its DX line of implantable cardioverter defibrillators (ICDs) 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 variations of this hybrid defibrillator are now available to U.S. patients. They are:

  • Inventra DX – an ICD system that can deliver ultra-high energy on the first shock offering better protection to patients that depend on this life-saving therapy; and
  • 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 James E. Stone, Jr., M.D., of Cardiology Associates of North Mississippi in Tupelo.

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

The DX System provides dual-chamber diagnostic capabilities with a single lead, which reduces risks associated with additional hardware for patients while providing valuable clinical information to the physician. The system utilizes the Linoxsmart S DX lead with floating dipole, based on proven technology, with a state-of-the-art ICD DX device – which has sophisticated atrial signal processing capabilities to provide dependable and consistent atrial signal to detect silent atrial fibrillation. SMART Detection algorithm and MorphMatch can discriminate atrial tachyarrythmias to help reduce the risk of inappropriate shocks.

For more information: www.biotronikusa.com

Related Content

News | EP Lab

October 6, 2021 – Biosense Webster announced the first cases using a radiofrequency balloon ablation catheter were ...

Home October 06, 2021
Home
News | EP Lab
October 1, 2021 — The European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization ...
Home October 04, 2021
Home
Videos | EP Lab
Khaldoun Tarakji, M.D., MPH, associate section head, cardiac electrophysiology, Heart and Vascular Institute at ...
Home October 04, 2021
Home
Feature | EP Lab

September 28, 2021 — New research from Washington University School of Medicine in St. Louis suggests that radiation ...

Home September 28, 2021
Home
News | EP Lab

September 1, 2021 — Stereotaxis and Shanghai Microport EP Medtech Co., Ltd. announced a broad collaboration to advance ...

Home September 01, 2021
Home
News | EP Lab

August 9, 2021 – Results from an international clinical trial show a significant reduction in risk of ventricular ...

Home August 09, 2021
Home
Feature | EP Lab

July 28, 2021 — Here is the complete list of late-breaking clinical trials (LBCT) and links to articles on all of them ...

Home August 09, 2021
Home
News | EP Lab | By Dave Fornell, Editor

August 5, 2021 — A prospective, non-randomized, multicenter, first-in-human clinical study found good diagnostic and ...

Home August 05, 2021
Home
News | EP Lab

August 3, 2021 — A subgroup analysis of the EAST – AFNET 4 study population revealed early initiation of rhythm control ...

Home August 03, 2021
Home
News | EP Lab

August 4, 2021 — Temporary Spinal cord stimulation (SCS) was effective in suppressing post-operative atrial fibrillation ...

Home August 03, 2021
Home
Subscribe Now