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December 23, 2025

FDA Expands Evolut Indication to Include Redo TAVI

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FDA Expands Evolut Indications to Include Redo TAVI

Yael L. Maxwell

August 29, 2025

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FDA Approves TAVI for Asymptomatic Patients With Severe Aortic Stenosis

May 01, 2025

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FDA Approves TriClip TEER Device for Tricuspid Repair

April 02, 2024

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Mechanism’s Mojo: ‘Obvious’ CV Therapies More Likely to Be Seen as Effective

February 23, 2024

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FDA Approves First Transcatheter Tricuspid Valve Replacement Device

February 02, 2024

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FDA Approves Blood Flow-Diverting LimFlow System for No-Option CLTI

September 12, 2023

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FDA Clears SAPIEN 3 With Alterra Prestent for Pulmonary Valve Replacement

December 20, 2021

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FDA Approves Portico TAVI Valve, Paving the Way for Third US Device

September 20, 2021

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FDA Approves Harmony TPV for Pulmonary-Valve Regurgitation in Congenital HD

Yael L. Maxwell

March 26, 2021

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European Regulators Approve First Transcatheter MV Replacement Device

January 30, 2020

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Sapien 3 Valve Approved in Europe for Low-Risk Patients

November 06, 2019

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FDA Expands TAVR Indication to Low-Risk Patients

August 16, 2019

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FDA Approves Lotus Edge, Ushering Third Device Into US Market

April 24, 2019

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FDA Extends MitraClip Indication to Include Functional MR

March 14, 2019

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FDA Approves Pea-Sized Occluder for Patent Ductus Arteriosus in Premature Babies

January 14, 2019

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FDA Clears Next-Generation Sapien 3 Ultra TAVR Valve

Todd Neale

January 02, 2019

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FDA Expands CoreValve Indication to Include Intermediate-Risk Patients

July 10, 2017

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FDA Expands Sapien 3 Indication to Aortic, Mitral Valve-in-Valve Replacement

June 06, 2017

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FDA Clears Sentinel Cerebral Protection Device for Use During TAVR