Tag: Impella

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...
impella in preventing heart failure in stemi patients

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...