Tag: Abiomed
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...
Abiomed given green light for RECOVER IV randomised trial
Abiomed has announced two approvals from the US Food and Drug Administration (FDA) related to clinic...
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...
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...
ADVERTORIAL: Further data underline the critical role of Impella Heart Pumps in Protected PCI
Findings from an interim analysis of PROTECT III have added to the evidence for improved outcome...
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...
ESC 2019: Abiomed launches Impella SmartAssist platform
At the 2019 European Society Cardiology (ESC) congress (31 August – 4 September, Paris, France),...
FDA approves extended duration of use for Impella 5.0 and Impella LD heart pumps
Abiomed has announced an expanded US Food and Drug Administration (FDA) approval for the Impella...
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 invests $15 million in Shockwave Medical
A press release reports that Abiomed is to invest US$15 million in Shockwave Medical and the two...
AHA 2018: Pilot study paves way for future evaluation of delaying reperfusion in STEMI patients
A pilot study comparing a strategy of left ventricular unloading with the Impella CP device (Abi...
TCT 2018: Use of Impella in cardiogenic shock patients associated with relative 24% increase in survival
A new analysis of data from the Impella (Abiomed) Quality (IQ) Database shows a relative increas...
Abiomed receives FDA approval for Impella CP with SmartAssist and Optical Sensor
Abiomed has received US FDA premarket approval (PMA) for its Impella CP heart pump with SmartAss...
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...
Haemodynamic support with Impella 2.5 heart pump significantly improves survival when initiated prior to PCI
A study published in the Journal of Interventional Cardiology indicates that the use o...
Abiomed introduces third generation Impella CP heart pumps at SCAI 2017
Abiomed has announced the debut of the third generation Impella CP heart pump at the Annual meet...
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...
