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William O'Neill, MD, Performs First Transcatheter Triscuspid Valve Replacement in the United States

August 12, 2014—Henry Ford Hospital in Detroit, Michigan, announced that William O’Neill, MD, Medical Director of Henry Ford’s Center for Structural Heart Disease, led a team in performing a transcatheter replacement of a failing tricuspid heart valve for the first time in the United States, and placed it just outside the heart.

PROTECT II

April 3, 2011—Abiomed, Inc. (Danvers, MA) announced that principal investigator William O'Neill, MD, presented the final results from the PROTECT II.

Abiomed's USpella Results Presented

May 25, 2010—Abiomed, Inc. (Danvers, MA) announced that William O'Neill, MD, presented updated clinical data from USpella at the EuroPCR 2010 conference in Paris.

Abiomed's USpella Results Presented at EuroPCR

May 25, 2010—Abiomed, Inc. (Danvers, MA) announced that William O'Neill, MD, presented updated clinical data from USpella at the EuroPCR 2010 meeting in Paris.

Abiomed Presents Final PROTECT II Results for High-Risk PCI Patients

April 3, 2011—Abiomed, Inc. (Danvers, MA) announced that principal investigator William O'Neill, MD, presented the final results from the PROTECT II study at the American College of Cardiology's (ACC) 60th annual scientific session in New Orleans.The PROTECT II study was a prospective, multicenter, randomized trial designed to measure a composite of major adverse events (MAE) at 30 days, with 90-day follow-up in high-risk percutaneous coronary intervention (PCI) patients requiring hemodynamic support, comparing the company's Impella 2.5 to the intra-aortic balloon pump (IABP).

PROTECT III Evaluates Abiomed’s Impella Placement Before High-Risk PCI

May 19, 2020—Abiomed announced that data from more than 1,000 patients demonstrated that the company’s Impella device reduces in-hospital mortality when placed before a nonemergent percutaneous coronary intervention (PCI) is performed.

Study Shows Abiomed's Impella Used With Best Practices Increases Survival of Cardiogenic Shock

September 24, 2018—Abiomed, Inc. announced that a new analysis of data from the company's Impella Quality (IQ) database shows a relative increase of 24% in mean survival in acute myocardial infarction (AMI) cardiogenic shock patients after FDA's postmarket approval of the Impella for cardiogenic shock.

Abiomed Ends PROTECT II Study and Announces Interim Results

December 6, 2010—Abiomed, Inc. (Danvers, MA) announced completion of the PROTECT II study.

National Cardiogenic Shock Initiative Publishes Final Results

December 18, 2023—Henry Ford Health in Detroit, Michigan, recently announced the publication of final results from the National Cardiogenic Shock Initiative (NCSI), which was led by a cardiology research team based at Henry Ford Hospital.

Interim Analysis Presented From PROTECT III Study of Abiomed’s Impella Device in High-Risk PCI Patients

October 15, 2020—Abiomed announced that new data from an interim analysis of the PROTECT III study demonstrate reduced rates of major adverse cardiac and cerebrovascular events (MACCEs; a composite of death, stroke, myocardial infarction, and repeat procedures) when the company’s Impella device is used to achieve more complete revascularization in a single setting for high-risk percutaneous coronary intervention (PCI) patients.

FDA Approves Abiomed’s RECOVER IV RCT With Exception From Informed Consent

September 16, 2022—Abiomed announced two FDA approvals related to clinical research of the company’s Impella heart pump in acute myocardial infarction (AMI) cardiogenic shock patients.

FDA Clears Siemens' 3D Angiography Imaging Software for TAVR

February 16, 2012—Siemens Healthcare (Malvern, PA) announced that it received US Food and Drug Administration clearance for the Syngo Aortic ValveGuide, an integrated image processing software intended for preparation and performance of transcatheter aortic valve replacement.

FDA Approves Abiomed's Impella CP With SmartAssist and Optical Sensor

April 2, 2018—Abiomed, Inc. announced that it has received US Food and Drug Administration (FDA) premarket approval for its Impella CP heart pump with SmartAssist, which utilizes an optical sensor.

FDA Approves Abiomed's Impella 2.5 for Elective and Urgent High-Risk PCI

March 23, 2015—Abiomed, Inc. announced that it has received US Food and Drug Administration (FDA) premarket approval (PMA) for the Impella 2.5 hemodynamic heart pump for use during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures.

Study Supports Safety of Door to Unloading With Abiomed's Impella CP System in STEMI Patients

November 11, 2018—Abiomed, Inc. announced the results of a trial investigating "door to unloading" (DTU) with the company's Impella CP system in patients with acute myocardial infarction.