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).

According to a news release issued by the U.S. Food and Drug Administration (FDA), Abiomed has recalled specific Impella 5.5 with SmartAssist for purge fluid leaks that can cause pump stop and loss of support. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

News | Heart Valve Technology

Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support

June 6, 2023 — According to a news release issued by the U.S. Food and Drug Administration (FDA), Abiomed has recalled ...

June 06, 2023

Long-Awaited Data Published in JAMA Confirms Minimally Invasive Procedure for Degenerative Mitral Regurgitation Is Successful in Nearly 90% of Patients

News | Structural Heart

Study: Transcatheter Mitral Valve Repair Safe, Successful

June 5, 2023 — Long-awaited outcomes data of transcatheter edge-to-edge procedures to repair patients’ leaky mitral ...

June 05, 2023

News | Structural Heart

Prowess, Persistence Yield First-anywhere Heart Procedure

March 16, 2023 — Cardiologists at the UW Medicine Heart Institute recently performed a first-in-the-world procedure ...

May 16, 2023

News | Heart Valve Technology

Edwards' Aortic Valve with Resilia Tissue Shows Favorable Durability, Safety and Efficacy Outcomes in 7-year Data

May 9, 2023 — Edwards Lifesciences announced new data from the COMMENCE aortic trial, demonstrating low rates of structu ...

May 09, 2023

GUARDIAN Registry data presented at ACC 2023 has shown use of the Paragonix SherpaPak Cardiac Transport System was associated with improved outcomes as compared to the use of traditional cold storage in LVAD patients undergoing Heart Transplantation

News | Heart Failure

Latest Clinical Evidence Points to Paragonix SherpaPak as a Tool to Reduce Unpredictable, Severe Complications following Heart Transplantation

April 6, 2023 — Paragonix Technologies, Inc., a leading organ transplant company, announces new research from a multi ...

April 06, 2023

The new valve is designed to preserve and facilitate future patient options for lifetime management of their heart valve disease

News | Structural Heart

Abbott Receives FDA Approval for Epic Max Tissue Valve to Treat Aortic Valve Disease

March 31, 2023 — Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company's Epic Max ...

March 31, 2023

The FDA is encouraging you to report adverse events related to Trifecta valves to the FDA.

News | Heart Valve Technology

FDA Issues Statement on Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration

February 28, 2023 — On Feb. 27, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers to ...

February 28, 2023

Leakage of the mitral valve due to degenerative prolapse is a common condition known as primary mitral regurgitation (MR).

News | Heart Valve Technology

Risk of Surgical Mitral Valve Repair for Primary Mitral Regurgitation

January 23, 2023 — Leakage of the mitral valve due to degenerative prolapse is a common condition known as primary ...

January 23, 2023

$Neovasc’s Innovative Reducer System will target the estimated $5 billion refractory angina market$

News | Structural Heart

Abbott Receives FDA Approval for Navitor TAVI System

January 19, 2023 — Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company's latest ...

January 19, 2023

The ensemble delivery system of the Melody valve.

News | Pediatric Cardiology

New Pediatric Investigation Article Reviews the Potential of Transcatheter Pulmonary Valve Replacement for Congenital Heart Disorders

January 6, 2023 — Patients with congenital heart diseases often suffer from obstructions in the right ventricular ...

January 06, 2023

The U.S. Food and Drug Administration (FDA) has given the approval to market to The Edwards Lifesciences PASCAL Precision Transcatheter Valve Repair System.

News | Heart Valve Technology

FDA Grants Approval to Market of PASCAL Precision Transcatheter Valve Repair System

January 2, 2023 — The U.S. Food and Drug Administration (FDA) has given the approval to market to The Edwards ...

January 02, 2023

News | Heart Valve Technology

Cedars-Sinai Designated as Mitral Valve Repair Reference Center

December 29, 2022 — The Smidt Heart Institute at Cedars-Sinai was named a Mitral Valve Repair Reference Center, a ...

December 29, 2022

Edwards Lifesciences identified the top data releases from 2022 that contributed most to shaping awareness about the extent and impact of underdiagnosis and undertreatment of aortic stenosis (AS).

News | Heart Valve Technology

Edwards Identifies Top Data Releases of 2022 that Highlight the Impacts of Aortic Stenosis Undertreatment

December 14, 2022 — Edwards Lifesciences identified the top data releases from 2022 that contributed most to shaping ...

December 14, 2022

Edwards Lifesciences Corporation announced that one-year results on patients treated in the single-arm, prospective, global, multi-center TRISCEND study of the company's EVOQUE transcatheter tricuspid valve replacement system demonstrated favorable safety, efficacy and quality-of-life outcomes.

News | Structural Heart

Edwards Announces One-year Data on Transfemoral Transcatheter Tricuspid Valve Replacement

December 13, 2022 — Edwards Lifesciences Corporation announced that one-year results on patients treated in the single ...

December 13, 2022

Boston Scientific Corporation has announced the first results from the ACURATE neo2 Post Market Clinical Follow-up (PMCF) study evaluating the performance of the ACURATE neo2TM Aortic Valve System.

News | Structural Heart

Late-Breaking Post-Market Study Data Reinforce Clinical Procedural Success and Safety of the ACURATE neo2 Aortic Valve System

December 2, 2022 — Boston Scientific Corporation has announced the first results from the ACURATE neo2 Post Market ...

December 02, 2022