Valvular heart disease

Abbott Receives FDA Approval for Minimally Invasive Portico™ with FlexNav™ TAVR System to Treat Patients with Aortic Valve Disease

Retrieved on: 
Monday, September 20, 2021

ABBOTT PARK, Ill., Sept. 20, 2021 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.

Key Points: 
  • ABBOTT PARK, Ill., Sept. 20, 2021 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery.
  • Aortic stenosis is one of the most common and life-threatening heart valve diseases.
  • With years of experience globally, Portico is a self-expanding TAVR valve with intra-annular (within the native valve) leaflets that help provide optimal blood flow (hemodynamics) when placed inside a patient's natural valve.
  • 2 Osnabrugge RLJ, Mylotte D, Head SJ, et al; Aortic Stenosis in the Elderly: Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study.

Prosthetic Heart Valve Devices and Equipment Global Market Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Monday, August 30, 2021

The "Prosthetic Heart Valve Devices and Equipment Global Market Report 2021: COVID-19 Impact and Recovery to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Prosthetic Heart Valve Devices and Equipment Global Market Report 2021: COVID-19 Impact and Recovery to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The prosthetic heart valve devices and equipment market consists of sales of prosthetic heart valve devices and equipment.
  • Therefore, various companies are focusing on development of polymeric heart valve technologies,
    Prosthetic heart valve devices have stringent procedures for approval which restrains the growth of the prosthetic heart valve devices and equipment market.
  • Global Prosthetic Heart Valve Devices And Equipment Market, Split By Region, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion
    7.2.

Insights on the Prosthetic Heart Valve Global Market to 2026 - by Type, Users and Geography - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 10, 2021

This report segments the prosthetic heart market based on type, user, and geography.

Key Points: 
  • This report segments the prosthetic heart market based on type, user, and geography.
  • By type, the market is segmented as mechanical heart valves and tissue heart valves.
  • By user, the prosthetic heart valve market is distinguished as hospitals and clinics, research and laboratories, and others.
  • Mechanical heart valves have better market standing and are projected to hold a dominating share in the prosthetic heart valve industry.

Virtual Care Up, Stethoscope Tests Down: Experts Concerned About Risk of Undiagnosed Heart Valve Disease

Retrieved on: 
Wednesday, July 7, 2021

61% of those surveyed say they have not had a stethoscope check, a key diagnostic tool for uncovering heart valve disease, for more than one year.

Key Points: 
  • 61% of those surveyed say they have not had a stethoscope check, a key diagnostic tool for uncovering heart valve disease, for more than one year.
  • We've got to help Canadians balance the benefits and ease of virtual care with also making sure to have their heart listened to.
  • This is especially important when you factor in population health studies which show the prevalence of heart valve disease and the fact that many people with heart valve disease do not have symptoms.
  • Detection of heart valve disease involves identifying a heart murmur using a stethoscope followed by an echocardiogram to confirm the diagnosis.

First Naturally-designed and Personalised Bioprosthesis SingValve Set to Revolutionise Heart Valve Surgery

Retrieved on: 
Thursday, July 1, 2021

As a personalised heart implant, based on pre-operative patient scans, the innovation has the potential to herald a new era of heart valve surgery.

Key Points: 
  • As a personalised heart implant, based on pre-operative patient scans, the innovation has the potential to herald a new era of heart valve surgery.
  • This newly-developed mitral valve bioprosthesis, named SingValve, mimics the appearance, form and physical properties of a human mitral valve.
  • SingValve was developed as a heart valve implant that is made for the individual patient.
  • The mitral valve is situated in the left heart chamber and separates the left atrium from the left heart ventricle.

#JustGo Campaign PSA Encourages Heart Valve Patients To Follow Up on Care

Retrieved on: 
Tuesday, June 15, 2021

Because of the COVID-19 pandemic, many heart valve patients have been unable or unwilling to follow up on their diagnosis and schedule necessary procedures.

Key Points: 
  • Because of the COVID-19 pandemic, many heart valve patients have been unable or unwilling to follow up on their diagnosis and schedule necessary procedures.
  • To address this potential health crisis, Heart Valve Voice US launched the #JustGo campaign earlier this year with aggressive social media and digital outreach.
  • Heart valve disease disproportionately affects older people, said John Lewis, Executive Director, Heart Valve Voice US.
  • Heart Valve Voice US is a nonprofit patient advocacy organization that provides a united voice for people living with heart valve disease.

Establishing TAVR for the Treatment of Aortic Regurgitation(1)

Retrieved on: 
Tuesday, June 15, 2021

This milestone includes patients enrolled in the multi-center prospective clinical trial, treating symptomatic, severe high surgical risk aortic regurgitation (AR) patients (The ALIGN-AR Clinical Trial).

Key Points: 
  • This milestone includes patients enrolled in the multi-center prospective clinical trial, treating symptomatic, severe high surgical risk aortic regurgitation (AR) patients (The ALIGN-AR Clinical Trial).
  • AR is a condition that occurs when a patients aortic valve does not close properly, resulting in reverse blood flow from the aorta back into the left ventricle.
  • The current treatment for high surgical risk patients who are not candidates for open-heart surgery is limited and consists of medical management.
  • JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K., and Munich, Germany, develops and manufactures transcatheter aortic valve implantation (TAVR) systems to treat patients suffering from aortic valve disease.

Global Tricuspid Valve Repair Market (2021 to 2025) - Size & Forecast with Impact Analysis of COVID-19 - ResearchAndMarkets.com

Retrieved on: 
Friday, June 11, 2021

Tricuspid valve disease often transpires with other heart valve problems.

Key Points: 
  • Tricuspid valve disease often transpires with other heart valve problems.
  • There are primarily two types of tricuspid valve disease that are tricuspid regurgitation (TR) and tricuspid stenosis.
  • For the treatment of patient's with such kind of disease tricuspid valve repair and tricuspid valve replacement treatments are opted such treatment cure diseases affecting the tricuspid valve.
  • Though, the growth of global tricuspid valve repair market would be negatively impacted by various challenges.

FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System

Retrieved on: 
Thursday, May 27, 2021

NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.

Key Points: 
  • NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.
  • The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system.
  • The safety and performance of MIA-T has been demonstrated in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites.
  • * We expect that breakthrough device designation will speed the process to commercialization so patients, physicians and the healthcare system can benefit from this technology."

FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System

Retrieved on: 
Thursday, May 27, 2021

NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.

Key Points: 
  • NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.
  • The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system.
  • The safety and performance of MIA-T has been demonstrated in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites.
  • * We expect that breakthrough device designation will speed the process to commercialization so patients, physicians and the healthcare system can benefit from this technology."