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Optimal Degree of Oversizing for TAVR Devices Evaluated

April 20, 2015—Danny Dvir, MD, et al published findings from an analysis of the association between CT-derived degrees of device oversizing and clinical outcomes during transcatheter aortic valve replacement (TAVR) using either the Sapien XT (Edwards Lifesciences) or the CoreValve (Medtronic plc) device.

Early and Newer-Generation TAVR Devices Compared in Patients With Native Aortic Valve Regurgitation

March 5, 2018—Danny Dvir, MD, presented the results of a trial investigating transcatheter aortic valve replacement (TAVR) for the treatment of pure native aortic valve regurgitation (NAVR) at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC.

Valve-in-Valve Registry Evaluates TAVR in Failed Bioprosthetic Surgical Valves

July 9, 2014—A study to determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves was published by Danny Dvir, et al for the Valve-in-Valve International Data (VIVID) Registry in the Journal of the American Medical Association (JAMA; 2014;312:162–170).

First Long-Term Study of Valve Durability Shows High Rates of Degeneration

May 17, 2016—The first study investigating the long-term durability of transcatheter aortic valve replacement (TAVR) found that approximately 50% of transcatheter heart valves (THVs) may undergo degeneration within 10 years.

Pi-Cardia’s ShortCut Device Used in FIH Procedures

January 7, 2021—Pi-Cardia Ltd. announced the successful first-in-human procedures with its ShortCut device, which is intended to provide coronary access and prevent coronary obstruction during transcatheter aortic valve replacement (TAVR).

Valve-in-Valve Procedures With Medtronic's CoreValve Approved in Europe

May 23, 2013—Medtronic, Inc. (Minneapolis, MN) announced it has received CE Mark approval for valve-in-valve (VIV) procedures using the CoreValve and CoreValve Evolut transcatheter aortic valve replacement (TAVR) systems in degenerated bioprosthetic surgical aortic valves.

Edwards Sapien XT Valve Receives FDA Approval for Valve-in-Valve Procedures; Data Presented at TCT

October 15, 2015—Edwards Lifesciences Corporation announced it has received US Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards Sapien XT transcatheter aortic valve replacement (TAVR) system.

Teleflex Commences Enrollment in ACCESS-MANTA Registry

November 16, 2023—Teleflex Incorporated announced the first patient enrollment in a clinical registry that is intended to examine and collect data on outcomes of contemporary on-label use of the company’s Manta vascular closure device (VCD) in transcatheter aortic valve replacement (TAVR) procedures.

FDA Approves Valve-in-Valve Procedures With CoreValve TAVR System

March 31, 2015—Medtronic plc announced US Food and Drug Administration (FDA) approval of the CoreValve transcatheter aortic valve replacement (TAVR) system for valve-in-valve (VIV) procedures in both high- and extreme-risk patients whose surgical aortic heart valves have failed.  The company stated that during the VIV procedure, the CoreValve system is placed inside a failing surgical heart valve with an inner diameter of 17 to 29 mm through a low-profile, 18-F delivery catheter.

Pi-Cardia’s ShortCut Pivotal Study Completes Enrollment

September 20, 2023—Pi-Cardia Ltd., an Israel-based developer of nonimplant, catheter-based, leaflet modification solutions for treating heart valves, announced the completion of enrollment in its ShortCut pivotal study.

Medtronic’s Evolut FX TAVI System Receives CE Mark Approval

October 13, 2023—Medtronic announced it has received European CE Mark approval for the Evolut FX transcatheter aortic valve replacement/implantation (TAVR/TAVI) system, the newest-generation system of the company’s CoreValve/Evolut TAVI platform.

Rouen Experience Supports Safety of TAVR Using Local Anesthesia

May 9, 2012—In an expedited publication online in the Journal of the American College of Cardiology: Cardiovascular Interventions, Eric Durand, MD, et al reported findings on the feasibility and 30-day outcomes of transcatheter aortic valve replacement (TAVR) with the Edwards Sapien and Edwards Sapien XT prostheses (Edwards Lifesciences, Irvine, CA) implanted exclusively using local anesthesia and fluoroscopic guidance.