Tag: Impella
ACC 2024: Use of Impella CP may boost survival in STEMI patients with cardiogenic shock
Use of the Impella CP (Abiomed) micro-axial flow pump in the treatment of patients with ST-segme...
Early use of mechanical support shows benefit for patients with AMI complicated by cardiogenic shock
Results of the National Cardiogenic Shock Initiative—a single-arm multicentre study assessing the fe...
US FDA accepts post-approval study reports for Impella
Abiomed has announced the US Food and Drug Administration (FDA) has accepted and closed the post...
Unloading with Impella for 30 minutes prior to PCI linked to reduced infarct size in STEMI patients
Results of a new per-protocol analysis of the ST-segment Elevation Myocardial Infarction Door-To...
Abiomed gains approval for data streaming from the Impella console
The US Food and Drug Administration (FDA) has approved one-way digital data streaming during pat...
Use of Impella CP is feasible in patients with severe aortic stenosis during high-risk percutaneous coronary intervention
Using an Impella device is contraindicated in patients with severe aortic stenosis with a valve ...
FDA issues IDE for Impella ECP and EUA for Impella RP
Abiomed has received investigational device exemption (IDE) from the US Food and Drug Administra...
SCAI 2020: PROTECT III shows placing Impella prior to high-risk PCI associated with lower mortality
Data from more than 1,000 patients presented during the virtual Society for Cardiovascular Angio...
Abiomed acquires novel ECMO developer Breethe
Abiomed (maker of the Impella heart pump) has acquired Breethe, developer of a novel extracorpor...
COVID-19: Edwards pauses enrolment in mitral and tricuspid trials to allow hospitals to focus on virus
Edwards Lifesciences has temporarily paused new enrolments in its active pivotal clinical trials...
New trial to evaluate role of Impella in preventing heart failure in STEMI patients
A pivotal, multicentre clinical trial is exploring the use of an Impella heart pump (Abiomed) to...
Abiomed announces PROTECT III clinical data for protected PCI with Impella
Abiomed has announced the results of PROTECT III, an ongoing, prospective, single-arm US Food an...
Challenges of conducting a randomised clinical trials to prove the impact of mechanical circulatory support in cardiogenic shock
Mechanical circulatory support is frequently used to stabilise patient haemodynamics in desperate si...
CE mark for cloud-based monitoring platform Impella Connect
Abiomed has achieved the CE mark for Impella Connect, which—a press release reports—is the first...
Abiomed receives expanded FDA approve for high-risk PCI procedures
Abiomed has received an expanded US FDA premarket approval for the Impella 2.5 and Impella CP he...
FDA grants Abiomed pre-market approval for is Impella RP for right heart failure
Abiomed has received FDA pre-market approval for its Impella RP heart pump. Culminating from fiv...
Patient enrolled in STEMI DTU feasibility study
Abiomed announced today the enrolment of the first patient in the FDA approved prospective feasibili...
Study indicates that Impella heart pump reduces acute kidney injury during high-risk PCI
A new study published in Circulation Research finds that the use of haemodynamic support with Im...
FDA pre-market approval for the Impella heart pump for high-risk PCI now includes Impella CP
Abiomed has expanded its FDA pre-market approval for Impella heart pump use in high-risk percuta...
Japan approves Abiomed’s Impella 2.5 and Impella 5.0 heart pumps
Abiomed has announced that its heart pumps Impella 2.5 and Impella 5.0 have received Pharmaceuti...