Heart Valve Technology

This channel includes news and new device innovations about heart valve technologies, including the aortic valve, mitral valve, pulmonic valve, and tricuspid valve. This includes information on transcatheter valve technologies like transcatheter aortic valve replacement (TAVR, or implantation TAVI), transcatheter mitral valve repair or replacement (TMVR), transcatheter and surgical valve repairs, and surgical replacement valves. Newer devices are now being used for transcatheter tricuspid valve repair replacement (TTVR). 

product comparison charts for cardiology and health IT systems
Feature | February 12, 2021
Cardiology Product Comparison Charts Aid in Buying Decisions
Diagnostic and Interventional Cardiology (DAIC) magazine maintains more than 50 comparison charts of product...
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The Carmat artificial heart
News | Artificial Heart | February 10, 2021
FDA OKs Use New Version of Carmat Artificial Heart in U.S. Early Feasibility Study
February 10, 2021 - The U.S. Food and Drug Administration (FDA) has granted artificial heart developer Carmat approval...
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Patients with bicuspid, or two-leaflet, aortic valves who undergo transcatheter aortic valve replacement (TAVR) procedures had a high rate of success and low risk of death or disabling stroke at 30 days, according to new data presented at the American College of Cardiology (ACC) 2020 Scientific Session.
News | Heart Valve Technology | February 04, 2021
Bicuspid Aortic TAVR May Create Huge Market For Transcatheter Valves
February 4, 2021 — Transcatheter aortic valve replacement (TAVR) has historically only been used with caution in the...
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A new CMS national coverage determination for reimbursement for MitraClip significantly expand access to transcatheter mitral valve repair procedures for secondary mitral regurgitation.
News | Heart Valve Technology | January 20, 2021
Medicare Expands Coverage for MitraClip in Heart Failure Patients
January 20, 2021 — The U.S. Centers for Medicare and Medicaid Services (CMS) revised its National Coverage...
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Medtronic Evolut TAVR Cleared in Canada for Both Bicuspid Valves in Intermediate or Greater Risk and for All Low Risk Patients for TAVR
News | Structural Heart | January 11, 2021
Canada Clears Medtronic Evolut TAVR for Both Bicuspid Valves and for All Low Risk Patients
January 11, 2021 — Medtronic has received a new expanded indication from Health Canada for its Evolut Transcatheter...
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The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to P+F Products + Features GmbH TricValve Transcatheter Bicval Valves System. The system uses two self-expanding valves in the vena cava for the treatment of patients with hemodynamically relevant tricuspid insufficiency without the need to touch the native tricuspid valve. #TTVR

The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to P+F Products + Features GmbH TricValve Transcatheter Bicval Valves System. The system uses two self-expanding valves in the vena cava for the treatment of patients with hemodynamically relevant tricuspid insufficiency without the need to touch the native tricuspid valve.

News | Structural Heart | January 06, 2021
FDA Grants Break Through Device Designation for TricValve Transcatheter Bicaval Valves System
January 6, 2021 — The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to P+F...
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First Patient Treated With Harpoon Transcatheter Mitral Valve Repair Device in U.S. Trial. #TMVR
News | Structural Heart | December 29, 2020
First Patient Treated With Harpoon Transcatheter Mitral Valve Repair Device in U.S. Trial 
December 29, 2020 — Edwards Lifesciences announced Dec. 21 that the first patient was treated in the RESTORE clinical...
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Health Canada has approved the expanded use of the Edwards Lifesciences Sapien 3 and Sapien 3 Ultra transcatheter aortic valve replacement (TAVR) heart valves for the transfemoral treatment of patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery. #TAVR #TAVI
News | Structural Heart | December 29, 2020
Edwards Sapien 3 TAVR Valve Receives Expanded Approval in Canada
December 29, 2020 — Health Canada has approved the expanded use of the Edwards Lifesciences Sapien 3 and Sapien 3 Ultra...
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COVID-19 related topics by far out-paced all other topics in cardiology in 2020 on the DAIC website. Several stories topped the list related to the cardiovascular issues with hydroxychloroquine being used as a treatment for the virus. Top new device technologies in 2020 included European approval of the Abbott Tendyne transcatheter mitral valve, FDA approval of Medtronic's new Micra AV pill-sized pacemaker, and FDA clearance of the first drug-eluting stent with short-duration dual-antiplatelet therapy.

COVID-19 related topics by far out-paced all other topics in cardiology in 2020 on the DAIC website. Several stories topped the list related to the cardiovascular issues with hydroxychloroquine being used as a treatment for the virus. Top new device technologies in 2020 included European approval of the Abbott Tendyne transcatheter mitral valve, FDA approval of Medtronic's new Micra AV pill-sized pacemaker, and FDA clearance of the first drug-eluting stent with short-duration dual-antiplatelet therapy (DAPT).

Feature | December 28, 2020 | Dave Fornell, Editor
Top 25 Stories in Cardiology in 2020
Here are the top 25 best performing articles on the Diagnostic and Interventional Cardiology (DAIC) website from 2020....
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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
Foldax to Initiate FDA Clinical Study of Biopolymer Mitral Heart Valve
December 14, 2020 - Foldax Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an...
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A recent publication demonstrated procedural efficiency for MitraClip transcatheter mitral valve repair (TMVR) with use of the Baylis VersaCross RF Transseptal Solution, reporting guide delivery from femoral access in under 7.5 minutes.
News | Hemodynamic Monitoring Systems | December 01, 2020
Study Finds TMVR Procedural Efficiency Using the VersaCross RF Transseptal Solution
December 1, 2020 — A recent publication demonstrated procedural efficiency for MitraClip transcatheter mitral valve...
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RIVER trial is the largest study assessing the efficacy and safety of the anticoagulant rivaroxaban in patients with an artificial mitral valve to correct an irregular heart rhythm
News | November 18, 2020
Rivaroxaban is Comparable to Warfarin for Bioprosthetic Mitral Valves and AF
November 18, 2020 — The primary results from the RIVER Trial, Rivaroxaban for Valvular Heart disease and Atrial...
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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
TAVR Is Now Dominant Form of Aortic Valve Replacement in the United States
November 17, 2020 — Since the approval of the first transcatheter aortic valve replacement (TAVR) device in 2011, more...
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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
Boston Scientific Pulls Lotus Edge TAVR Valve Off The Market
November 17, 2020 — Boston Scientific Corp. announced today it is immediately retiring the entire Lotus Edge...
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Some of the device technologies discussed in the TCT 2020 late-breaking trial sessions. Top left, the  Medtronic Resolute Onyx stent was the first stent to receive FDA clearance for short duration dual-antiplatelet therapy, which was a big topic and subject of several sessions. Lower left, the Keystone TriGuard 3 TAVR embolic protection device did not demonstrate superiority over TAVR without use of embolic protection. Top right, the Abbott MitraClip. Acurate neo TAVR valve. #TCTconnect #TCT2020

Some of the device technologies discussed in the TCT 2020 late-breaking trial sessions. Top left, the Medtronic Resolute Onyx stent was the first stent to receive FDA clearance for short duration dual-antiplatelet therapy, which was a big topic and subject of several sessions. Lower left, the Keystone TriGuard 3 TAVR embolic protection device did not demonstrate superiority over TAVR without use of embolic protection. Top right, the Abbott MitraClip was the subject of two studies, including use to aid heart transplant patients. Bottom right, the Boston Scientific Acurate neo TAVR valve performed below the Sapien 3 and CoreValve Evolut.

Feature | TCT | October 29, 2020 | Dave Fornell, Editor
Top 10 Takeaways on Interventional Technologies at TCT 2020
Here are some of the key takeaways from the late-breaking interventional cardiology and structural heart trials...
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