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

BERLIN, Germany, August 07, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today the first enrollments in the BIO|GUARD-MI study¹. 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 (MACE²). The study will, for the first time ever, examine patients with relatively preserved ejection fraction (LVEF > 35%), who have experienced acute myocardial infarction (AMI).

BioMonitor is a unique and leadless cardiac monitor implanted under the skin and 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 study³ indicated that a cardiac arrhythmia is the most powerful predictor for a MACE in post-AMI patients who have a left ventricular ejection fraction (LVEF) ≤ 40%. Of these patients, 20% experienced a major cardiovascular event within two years. From those, more than 80% 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 to 90% of patients who survive AMI have relatively preserved ejection fraction with LVEF > 35%. BIO|GUARD-MI will now look at whether these patients receive similar benefits from using BioMonitor, as patients with lower LVEF.

“Studies such as IN-TIME⁴, COMPAS⁵ and TRUST⁶ have demonstrated that BIOTRONIK Home Monitoring greatly improves clinical outcomes for pacemaker, ICD and CRT patients,” added Klaus Contzen, Director Clinical Affairs at BIOTRONIK. “We expect BIO|GUARD-MI to demonstrate a clinical benefit for post AMI patients who don´t have a pacemaker or ICD indication yet as well, thus proving BioMonitor’s benefits for a broad range of patient populations. Thanks to the combination of BioMonitor and Home Monitoring, we are now able to assess this underexplored patient population for the
first time.”

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.

1. ^{BIO monitoring in patients with preserved left ventricular function after diagnosed
   acute myocardial infarction.}
2. ^{Several severe cardiovascular complications can be classified under the term MACE, such as: cardiovascular death, acute unscheduled hospitalization due to: worsening of the patient status due to heart failure, arrhythmia, acute coronary syndrome, stroke, major bleeding, systemic embolism.}
3. ^{Jons C, Thomsen PE. Cardiovasc Med. 2012, 14 (1).}
4. ^{Hindricks G, et al. The Lancet. 2014, 384 (9943).}
5. ^{Mabo P, et al. Eur Heart J. 2012, 33 (9).}
6. ^{Varma N, et al. Eur Heart J. 2014, 35 (20).}