The US Food and Drug Administration's (FDA) Circulatory System Devices Panel votes to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Abiomed's Impella.
Abiomed receives 510(k) clearance from the US Food and Drug Administration (FDA) for a new percutaneous, catheter-based Impella device providing peak flows of approximately four litres of blood per minute.
Abiomed receives CE Marking approval in the European Union to market the Impella cVAD device, a new percutaneous Impella heart pump that provides peak flow of approximately four litres of blood per minute.
Abiomed enrolls its first patient in the MINI-AMI, an FDA prospective, randomized, controlled multi-centre study to assess the role of 24-hours of direct unloading of the left ventricle with Impella 2.5 support to reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) without
Abiomed receives conditional approval from the US Food and Drug Administration to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI).
Abiomed is launching a specialised partner programme that enables select top healthcare institutions to provide advanced training in haemodynamic support and complex patient management to better facilitate heart muscle recovery.
Abiomed reports that the first patient was successfully supported for six days by the Impella Right Peripheral (RP) at the Providence Heart + Lung Institute at St Paul’s Hospital in Vancouver, British Columbia.
Abiomed forms a strategic partnership with Opsens, a leading developer of fibre optic sensors which will see Opsens' breakthrough sensor technology being integrated into the Impella catheter to provide robust blood pressure measurements that can be used to enhance Impella's performance and ease-of-use.
Results from the Europella registry, evaluating the safety and feasibility of the Abiomed Impella 2.5 circulatory assist device in high-risk percutaneous coronary intervention (PCI) procedures is now published the Journal of the American College of Cardiology (JACC).
Investor and analyst meeting kicks off series of symposia and presentations from Abiomed being held at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco held during the week of September 21st
Abiomed has received CE Mark approval for its Portable Circulatory Support Driver which enables the device to be sold in all European Union countries as well as many other countries worldwide that accept this approval for registration.
Abiomed has received the CE Mark for its Portable Circulatory Support Driver and will now be able to sell the device in all European Union countries as well as many other countries worldwide that accept this approval for registration.