Structural Heart

This structural heart channel includes news, videos, podcasts and other content related to diagnosis and treatment of structural heart disease. Topics covered include heart valve repair and replacement, transcatheter aortic valve replacement (TAVR), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve replacement (TTVR), left atrial appendage (LAA) occlusion, heart failure interventional device therapies, and closing holes in the heart using, including occlusion of atrial septal defects (ASDs), ventricular septal defects (VSDs) and patent foramen ovales (PFOs).

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 ...

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Videos | Structural Heart
VIDEO: PFO Closure Shows Continued Stroke Prevention Benefit at 5 Years

Interview with Scott E. Kasner, M.D., who served as the principle investigator for the Gore Cardioform REDUCE trial, and ...

Home March 23, 2021
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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 ...

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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 ...

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AMERICAN COLLEGE OF CARDIOLOGY (ACC) Late-breaking clinical trial study presentations at ACC.21. @ACC21 @ACC2021
Feature | ACC | Dave Fornell, Editor
ACC 2021 Late Breaking Cardiology Study Results

The latest cardiology practice-changing scientific breakthrough, late-breaking study presentations have been announced ...

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The Occlutech implantable Atrial Flow Regulator (AFR) maintains an interatrial shunt with a predetermined diameter allowing for controlled blood flow from the left to the right atrium enabling the left atrium to decompress and lower left atrial pressure. This reduced left atrial pressure reduces heart failure symptoms and improves exercise tolerance.
News | Heart Failure
Occlutech Completes Enrollment in Pilot Study of Heart Failure Atrial Flow Regulator

February 24, 2021 — Occlutech announced the completion of patient enrollment in the PRELIEVE trial, pilot study to ...

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The Carmat artificial heart
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 ...

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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
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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The Occlutech implantable Atrial Flow Regulator (AFR) maintains an interatrial shunt with a predetermined diameter allowing for controlled blood flow from the left to the right atrium enabling the left atrium to decompress and lower left atrial pressure. This reduced left atrial pressure reduces heart failure symptoms and improves exercise tolerance.
News | Heart Failure
Occlutech's Atrial Flow Regulator for Heart Failure Receives FDA Breakthrough Device Designation

January, 27, 2021 — The U.S. Food and Drug Administration (FDA) has granted Occlutech a Breakthrough Device designation ...

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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
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 ...

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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
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
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 ...

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The most popular DAIC content in December 2020 included the Boston Scientific Lotus TAVR valve being taken off the market, CMS approving expanding coverage of LVADs for more Medicare patients and numerous COVID-19 related cardiology stories and videos.
Feature
Most Popular Cardiology Technology Content in December 2020

January 5, 2021 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC) ...

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First Patient Treated With Harpoon Transcatheter Mitral Valve Repair Device in U.S. Trial. #TMVR
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 ...

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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
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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