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Funding for this supplement provided by Medtronic
TAVR Optimization Using Best Practices
By Mathew Williams, MD; Michael Querijero, MSPA; and Tara Collins, MSPA; on behalf of New York University Langone Medical Center, New York, NY
Femoral and Apical Closure Devices for TAVR
Closure devices in various stages of development that may help reduce access-related complications.
By Jonathon White, MD, and Mathew Williams, MD
FIH Implantation Performed With Thubrikar's Optimum TAV System
January 14, 2019—Thubrikar Aortic Valve, Inc. announced the first-in-human (FIH) implantation of its Optimum transcatheter aortic valve (TAV) system.
FDA Approves Medtronic's CoreValve Evolut R 34-mm Recaptureable TAVR System
October 26, 2016—Medtronic plc announced the US Food and Drug Administration (FDA) approval and United States launch of the CoreValve Evolut R 34-mm transcatheter aortic valve replacement (TAVR) system.
LivaNova Concludes PRELUDE Study for Caisson TMVR System
August 6, 2018—LivaNova PLC announced the conclusion of the PRELUDE feasibility study for its Caisson transcatheter mitral valve replacement (TMVR) system.
Innovations
Thubrikar’s Optimum TAV Device Evaluated at 30 Days in TAVI-1 Study to Enable CE Mark Approval
August 2, 2022—Thubrikar Aortic Valve, Inc., announced the 30-day outcomes in the first two patients receiving transcatheter aortic valve implantation (TAVI) with the company’s Optimum TAV device in the TAVI-1 study.
Thubrikar’s Optimum TAVI Device Will Be Studied to Gain CE Mark Approval
December 17, 2021—Thubrikar Aortic Valve, Inc. announced that it received approval from a Competent Authority in Poland to conduct initial patient implantations with its Optimum transcatheter aortic valve implantation (TAVI) system.
Micro Interventional Devices MIA-T Tricuspid Annuloplasty System Granted FDA Breakthrough Device Designation
May 27, 2021—Micro Interventional Devices (MID) has received FDA Breakthrough Device designation for its MIA-T percutaneous tricuspid minimally invasive annuloplasty system.
United States Clinical Study Begins For Medtronic's CoreValve Evolut R Recapturable TAVR System
September 10, 2014—Medtronic, Inc. announced the first procedures in the United States in the CoreValve Evolut R clinical study.
First Patient Enrolled in STTAR Study's Transcatheter Arm of Micro Interventional Devices' Annuloplasty Technology
October 12, 2018—Micro Interventional Devices, Inc. announced the first percutaneous implantation of the company's minimally invasive annuloplasty (MIA) technology for tricuspid and mitral repair.
Medtronic's CoreValve Evolut R TAVR System Approved by FDA
June 23, 2015—Medtronic plc announced United States Food and Drug Administration (FDA) approval and the United States launch of the new recapturable, self-expanding CoreValve Evolut R system.
The Ins and Outs of Access and Closure
By Ted E. Feldman, MD, MSCAI, FACC, FESC
Medtronic's CoreValve Evolut Pro Transcatheter Valve Approved by FDA
March 23, 2017—Medtronic announced US Food and Drug Administration approval and the United States launch of its CoreValve Evolut Pro transcatheter valve system for the treatment of severe aortic stenosis in symptomatic patients who are at high or extreme risk for open heart surgery.
Thubrikar Aortic Valve’s TAVI-1 CE Mark Trial Receives Expanded Authorization
December 15, 2023—Thubrikar Aortic Valve, Inc. announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the company’s Optimum TAV, a transcatheter aortic valve implantation/replacement (TAVI/TAVR) system.
Early Feasibility PRELUDE Study Begins for Caisson's TMVR System
October 11, 2016—Caisson Interventional, LLC recently announced the commencement of the early feasibility PRELUDE study, which is being conducted under an investigational device exemption (IDE) to provide initial data on the safety and performance of the Caisson transvascular mitral valve replacement (TMVR) system.
United States Enrollment Begins in Early Feasibility Study of HLT's TAVR System
June 6, 2017—HLT, Inc. announced that the first United States procedures were performed in the early feasibility RADIANT clinical study.
FDA Approves Medtronic's Next-Generation Evolut Pro+ TAVR System
September 23, 2019—Medtronic announced FDA approval and the United States launch of the company's Evolut Pro+ transcatheter aortic valve replacement (TAVR) system, which builds off the company's self-expanding, supra-annular Evolut TAVR platform.
Current Approach to Slow Flow and No-Reflow
A preventive approach appears to be the best strategy based on current understanding of this phenomenon.
By Sandhir Prasad, MBBS, FRACP, and Ian T. Meredith, MBBS, PhD, FRACP, FACC, FSCAI
The Role of Coronary CT in Determining Lesion-Specific Ischemia and Coronary Plaque Vulnerability
What are the current data and applications?
By Venkat S. Manubolu, MD, MPH, and Matthew J. Budoff, MD
