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).

News | Artificial Heart

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 ...

February 10, 2021

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

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 ...

February 04, 2021

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

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 Determination ...

January 20, 2021

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

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 ...

January 11, 2021

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

News | Structural Heart

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 ...

January 06, 2021

News | Structural Heart

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 ...

December 29, 2020

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

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 ...

December 29, 2020

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.

Feature | 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 ...

December 28, 2020

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

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 ...

December 14, 2020

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

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 ...

December 01, 2020

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

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 ...

November 18, 2020

Feature | Heart Valve Technology

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 ...

November 17, 2020

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 | 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 ...

November 17, 2020

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

Feature | TCT | 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 ...

October 29, 2020

Videos | Heart Valve Technology

VIDEO: Results Mixed on Use of Cerebral Embolic Protection in TAVR From the STS/ACC TVT Registry

David Cohen, M.D., presents late-breaking data from the STS/ACC Transcatheter Valve Registry (TVT) showing the impact of ...

October 19, 2020