Abiomed has secured investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to start door to unloading (DTU) study with Impella CP heart pump.
The study will assess the use of 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.
Currently, the Impella heart pumps are not approved for use in STEMI patients without cardiogenic shock.
The study, "Door to Unloading (DTU) with Impella CP System in Acute Myocardial Infarction to Reduce Infarct Size," is a prospective and multi-center feasibility study that will be carried out under the guidance of principal investigators Dr Navin Kapur from Tufts Medical Center and Dr William W. O`Neill from Henry Ford Medical Center.
The study, which will recruit around 50 patients at 10 sites, is expected to start in the first half of 2017 and complete within 18 months.
The primary endpoint of the study will evaluate infarct size as percent of left ventricular mass at 30 days post-PCI using a cardiac magnetic resonance (CMR) imaging technique.
Abiomed will randomize patients to Impella CP placement with immediate primary PCI or Impella CP placement with 30 minutes of unloading prior to primary PCI.
According to the firm, the study is designed to assess safety and the protocol and not sized to show significant statistical difference.
Dr Navin Kapur said: "As clinicians and scientists, we appreciate the FDA`s approval of this feasibility study.
"And we are excited to further investigate whether mechanically reducing the workload of the heart before reopening a blocked coronary artery reduces myocardial damage and the subsequent development of heart failure."