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).

Transesophageal echo (TEE) being used to guide the deployment of a MitraClip device during a transcatheter structural heart procedure in the hybrid lab at the University of Colorado Hospital. The center has performed more than 200 MitraClip mitral valve repairs over the past decade. Photo by Dave Fornell

Blog | Structural Heart

Creating a Structural Heart Program is an Investment in the Future of the Hospital

As a medical technology journalist, a little more than a decade ago I found myself sitting in those late afternoon ...

April 21, 2021

The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical AcQCross family of universal transseptal crossing devices. This is the only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ own suite of sheaths and with sheaths sold by other manufacturers.

News | EP Lab

FDA Clears Acutus Medical AcQCross Suite of Transseptal Crossing Devices

April 14, 2021 — The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical AcQCross family of universal ...

April 14, 2021

The new generation Abbott TriClip G4 device has gained European and Canadian approvals for transcatheter tricuspid valve repair (TTVR).

News | Structural Heart

Abbott Receives CE Mark and Canadian Approval for Next-Generation TriClip Tricuspid Valve Repair Device

April 8, 2021 — Abbott today announced it has received European CE mark and Health Canada authorization this week for ...

April 08, 2021

The Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System. It is first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT) to stop severe pulmonary valve regurgitation caused by congenital heart disease.

Feature | Structural Heart | By Dave Fornell, Editor

FDA Clears First Device to Treat Right Ventricular Outflow Tract Congenital Heart Disease

March 26, 2021 — Today, the U.S. Food and Drug Administration (FDA) cleared the Medtronic Harmony Transcatheter ...

March 26, 2021

University of Minnesota researchers used a hybrid of tissue engineering and regenerative medicine to create heart valves that can grow with the recipient. When implanted in lambs, researchers showed that the tri-tube valves worked better than current animal-derived valves with almost none of the calcification or blood clotting that the other valves showed. This can be implanted in pediatric patients with congenital heart diseas. Photo from Syedain, et al., Tranquillo Lab, University of Minnesota

News | Heart Valve Technology

Lab-created Heart Valves Can Grow With the Patient

March 18, 2020 — A groundbreaking new study led by University of Minnesota Twin Cities researchers from both the College ...

March 18, 2021

The Teleflex Manta large-bore vascular closure device can seal holes between 12 and 25 French.

Feature | Hemostasis Management | Dave Fornell, Editor

Large Bore Closure in Structural Heart Interventions

While many cardiac and vascular procedures have largely moved to minimally invasive techniques, the size of these ...

March 09, 2021

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