Transcatheter Valves

Last updated on May 28, 2020
CompanyProduct
Boston ScientificAcurate neo Aortic Valve System
Boston ScientificLotus Edge Aortic Valve System
Edwards LifesciencesSapien 3 Ultra Valve
MedtronicCoreValve Evolut R
MedtronicMelody Transcatheter Pulmonary Valve (TPV)

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Foldax Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) so the company to initiate a U.S. clinical study of its Tria biopolymer mitral surgical heart valve.
News | Heart Valve Technology | December 14, 2020
December 14, 2020 - Foldax Inc. today announced that the U.S.

The Edwards Lifesciences Sapien 3 TAVR valve. The annual volume of TAVR has increased each year and in 2019 TAVR volume (72,991) exceeded all forms of SAVR (57,626), coinciding with the U.S. Food and Drug Administration (FDA) approval of TAVR for low-risk patients. 

Feature | Heart Valve Technology | November 17, 2020
November 17, 2020 — Since the approval of the first transcatheter aortic valve replacement (TAVR) device in 2011, mor
oston Scientific Corp. announced today it is immediately retiring the entire Lotus Edge transcatheter aortic valve replacement (TAVR) system. It also initiated a global, voluntary recall of all unused inventory of the Lotus Edge due to complexities associated with the product delivery system. 
Feature | Heart Valve Technology | November 17, 2020 | Dave Fornell, Editor
November 17, 2020 — Boston Scientific Corp.
The Keystone Heart TriGuard 3 (TG3) is a self-stabilizing cerebral embolic deflection filter used in patients undergoing transcatheter aortic valve replacement (TAVR). The device is designed to reduce TAVR complications of cerebral embolization and ischemic stroke. #TCT #TCT2020 #TCTconnect

The Keystone Heart TriGuard 3 (TG3) is a self-stabilizing cerebral embolic deflection filter used in patients undergoing transcatheter aortic valve replacement (TAVR). The device is designed to reduce TAVR complications of cerebral embolization and ischemic stroke. 

News | Heart Valve Technology | October 15, 2020
October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of the Keystone Heart
The Boston Scientific Acurate neo self-expanding TAVR valve (left) did not perform as well clinically as the Medtronic CoreValve Evolut TAVR valve (right) in the SCOPE II trial presented at TCT 2020. #TCT #TCT2020 #TCTconnect

The Boston Scientific Acurate neo self-expanding TAVR valve (left) did not perform as well clinically as the Medtronic CoreValve Evolut TAVR valve (right) in the SCOPE II trial presented at TCT 2020.

Feature | Heart Valve Technology | October 15, 2020
October 15, 2020 – The SCOPE II trial comparing the Boston Scientific Acurate neo vs.
An illustration showing the MitraClip catheter entering the left atrium through a transseptal puncture. #TCT2020 #TCTconnect

An illustration showing the MitraClip catheter entering the left atrium through a transseptal puncture.

News | Heart Valve Technology | October 15, 2020
October 15, 2020 – The...
Medtronic is starting a randomized, head-to-head study comparing the Medtronic CoreValve Evolut Pro and Pro+TAVR Systems against the balloon-expandable Edwards Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valvestwo transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). 

Medtronic is starting a randomized, head-to-head study comparing the Medtronic CoreValve Evolut Pro and Pro+TAVR Systems against the balloon-expandable Edwards Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valvestwo transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). 

News | Heart Valve Technology | October 14, 2020
October 14, 2020 — Medtronic announced it is starting a randomized, head-to-head study comparing two transcatheter ao