News | Implantable Cardiac Monitor (ICM) | August 11, 2015

Biotronik Announces First Enrollments in the BIO|GUARD-MI Study

Study evaluates whether early remote detection of cardiac arrhythmias reduces major cardiovascular events in post-acute myocardial infarction patients

Biotronik, BIOGUARD-MI Study, BioMonitor, cardiac arrhythmias, early detection, remote monitoring

August 11, 2015 — Biotronik announced the first enrollments in the BIO|GUARD-MI1 study. The study will investigate whether the early detection of cardiac arrhythmias offered by BioMonitor, and subsequent treatments, reduce the likelihood of major adverse cardiovascular events (MACE). The study will, for the first time ever, examine patients with relatively preserved left ventricular ejection fraction (LVEF > 35 percent), who have experienced acute myocardial infarction (AMI).

BioMonitor is a leadless cardiac monitor implanted under the skin, intended to track cardiac electric activity and provide long-term remote monitoring of patients with arrhythmias. It uses Biotronik Home Monitoring for the automatic daily transmission of information on both the patient's clinical and device status.

"From previous study results, we already know just how important cardiac arrhythmia can be as an indicator of further critical events in heart patients," commented coordinating clinical investigator Christian Jons, Rigshospitalet Heart Center, Copenhagen, Denmark. "The question now, which we hope to address with the BIO|GUARD-MI study, is whether highly accurate and reliable monitoring tools like BioMonitor with Home Monitoring, can help us identify early warning signs, thereby leading to faster treatment while minimizing direct interference in patients' lives."

A previous study indicated that a cardiac arrhythmia is the most powerful predictor for a MACE in post-AMI patients who have an LVEF ≤ 40 percent. Of these patients, 20 percent experienced a major cardiovascular event within two years. From those, more than 80 percent were diagnosed with a cardiac arrhythmia before the event by using an implantable cardiac monitor. However, the patient group with a relatively preserved ejection fraction after AMI is quite large, but until now underrepresented in clinical studies. 80-90 percent of patients who survive AMI have relatively preserved ejection fraction with LVEF > 35 percent. BIO|GUARD-MI will now look at whether these patients receive similar benefits from using BioMonitor, as patients with lower LVEF.

The prospective, controlled, randomized, multicenter trial will enroll 2,900 patients in approximately 35 centers worldwide. The primary endpoint is the time from randomization to the first MACE.

For more information: www.biotronik.com

Related Content

Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD
Technology | Implantable Cardioverter Defibrillator (ICD)| September 22, 2017
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab| August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Overlay Init