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FDA Classifies Two Field Actions Related to Medtronic’s HeartWare HVAD System as Class 1 Recalls

September 30, 2016 -- Medtronic plc announced today that two previously communicated global voluntary recalls related to the HeartWare International HVAD system, a full-suppor…

Abiomed’s Impella 2.5 and Impella 5.0 Heart Pumps Approved in Japan

September 27, 2016 -- Abiomed, Inc. announced that the company’s Impella 2.5 and Impella 5.0 heart pumps received Pharmaceuticals and Medical Devices Agency (PMDA) appro…

Edwards Sapien 3 TAVR Device Receives Intermediate-Risk Indication in Europe

September 19, 2016 -- Edwards Lifesciences Corporation announced that it has received CE Mark approval to expand use of the Sapien 3 transcatheter aortic valve replacemen…

Boston Scientific Receives CE Mark Approval for Lotus Edge Valve System

September 19, 2016 -- Boston Scientific Corporation announced European CE Mark approval for the Lotus Edge valve system, the company's next-generation transcatheter aortic…

FDA Approves Bolus Vial Format for Medicure’s Aggrastat

September 1, 2016 -- Medicure Inc. announced that it has received approval from the US Food and Drug Administration (FDA) for its new "bolus vial" product format for…

FDA Approves Expanded Indication for Edwards' Sapien 3 TAVR Device

August 18, 2016 -- Edwards Lifesciences Corporation announced US Food and Drug Administration (FDA) approval to expand use of its Sapien 3 transcatheter aortic valve repl…

CMS Approves LAAO Registry

August 18, 2016 -- The American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) advised that the LAAO Registry has been ide…

FDA Issues Draft Updated Recommendations on 510(k) Clearance of Device Modifications

August 8, 2016 -- The US Food and Drug Administration (FDA) announced this week that the agency has issued draft updated recommendations on submissions for a new 510(k) c…



2018 Buyer’s Guide

This Buyer’s Guide offers a searchable, comprehensive listing of the FDA-approved interventional devices available in the United States.


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About Cardiac Interventions Today

Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.