HeartWare International Inc. announced that enrollment in the ENDURANCE2 destination therapy clinical trial has been completed. ENDURANCE2 is the largest destination therapy clinical trial of a ventricular assist device conducted to date and is designed to evaluate patients implanted with the HeartWare Ventricular Assist Device (HVAD) for long-term use as destination therapy in the United States. Data from the ENDURANCE program are expected to form the basis for a pre-market approval (PMA) application seeking approval of the HeartWare System for destination therapy.

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).

Several common measures obtained from electrocardiograms (ECGs) may help clinicians determine a kidney disease patient’s risk of dying from heart disease. The findings, which are published in a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN), may be important for preserving kidney patients’ heart health.

The American College of Cardiology (ACC) has announced that Boehringer Ingelheim is the newest industry sponsor of The Diabetes Collaborative Registry. The registry is an interdisciplinary effort led by the college in partnership with the American Diabetes Association, the American College of Physicians, the American Association of Clinical Endocrinologists and the Joslin Diabetes Center.

Merit Medical Systems Inc. announced that it has expanded its Europe, Middle East and Africa (EMEA) distribution center and corporate office in Maastricht, the Netherlands.

The American College of Cardiology (ACC) convened leaders in all aspects of healthcare the week of July 27 for a two-day Population Health Retreat to discuss how to focus resources to prevent heart disease and related health conditions.

The U.S. Food and Drug Administration (FDA) is alerting healthcare providers, patients and caregivers about serious adverse events associated with left ventricular assist devices (LVADs). These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices. The agency is also aware of bleeding complications associated with both devices.