Industry Press Releases

Sep 17, 2022 | Industry Press Releases
Unloading with Impella® for 30 Minutes Before PCI Associated with Reduced Infarct Size in STEMI Patients

BOSTON–(BUSINESS WIRE)–Results of a new per-protocol analysis of the ST-segment Elevation Myocardial Infarction Door-To-Unload (STEMI DTU) pilot trial data show significantly reduced infarct size in patients who received left ventricular (LV) unloading with Impella CP for 30 minutes prior to their percutaneous coronary intervention (PCI) compared to patients who received LV unloading followed by immediate PCI.

Sep 16, 2022 | Industry Press Releases
FDA Approves RECOVER IV Randomized Controlled Trial with Exception from Informed Consent (EFIC)

DANVERS, Mass. – September 16, 2022 – Abiomed (Nasdaq: ABMD) announces two approvals from the U.S. Food and Drug Administration (FDA) related to clinical research of Impella® heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients.

Sep 15, 2022 | Industry Press Releases
Edwards PASCAL Precision Transcatheter Valve Repair System Receives FDA Approval For Degenerative Mitral Regurgitation

IRVINE, Calif., Sept. 15, 2022 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), today announced the company’s PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral regurgitation (DMR).

Sep 12, 2022 | Industry Press Releases
Edwards Launches SAPIAN 3 Ultra RESILIA Valve Following FDA Approval

IRVINE, Calif., Sept. 12, 2022 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced the launch of the SAPIEN 3 Ultra RESILIA valve, which incorporates Edwards’ breakthrough RESILIA tissue technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve. The launch follows recent U.S. Food and Drug Administration (FDA) approval.

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