Abiomed Receives FDA IDE Approval for Initiation of Door to Unloading (DTU) Prospective Feasibility Study

DANVERS, Mass., Oct. 27, 2016 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today the U.S. Food and Drug Administration (FDA) approval of a prospective feasibility study to evaluate the use of the Impella CP heart pump for unloading of the left ventricle prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST segment elevation myocardial infarction (STEMI), without cardiogenic shock. This trial will focus on feasibility and safety, and lay the groundwork for a future trial, designed to measure the impact that unloading may have on infarct size related to reperfusion injury, an acceleration of myocardial damage at the time of revascularization, in STEMI patients. Impella® heart pumps are not currently approved for use in STEMI patients without cardiogenic shock. The STEMI patient segment is contributing to the growing heart failure population and represents a potential new patient indication that may benefit from Impella pump unloading the left ventricle. STEMI is a type of heart attack caused by a blockage in one of the main heart arteries, preventing the flow of oxygen to the heart. It is estimated that 965,000 people a year have heart attacks 1 , of which approximately 200,000 are classified as STEMI2. The current standard of care is called Door to Balloon “DTB”, for the angioplasty balloon. The recommended treatment in guidelines for STEMI is revascularization (opening the blocked artery) to restore oxygen supply to the heart muscle through primary PCI within 90 minutes or less from the time of first medical contact. Despite current guidelines, 76% of patients experiencing their first acute myocardial infarction (AMI), will develop heart failure within five years 3 . Additionally, within five years of a patient surviving their first heart attack, 36% of men and 47% of women will die due to heart failure1. It is estimated that the number of heart failure patients will grow to 8 million people by 2030 with enormous associated costs 4 . Survival from heart attacks has been improved by the successful DTB protocol; however, this treatment is speculated to be contributing to the growing epidemic of heart failure.