1. Medtech Insight
  2. >>Business

Cardio Catch-Up: FDA Approves Edwards Evoque Transcatheter Tricuspid Valve Sooner Than Expected

 
• By Reed Miller

Edwards' Evoque is the first transcatheter therapy to receive FDA approval for the treatment of tricuspid regurgitation. The FDA-approved labeling says it can improve patients' "health status" but the company may be able to soon upgrade that indication to include a mortality benefit claim, which could give Evoque an important advantage over tricuspid valve repair devices.

Edwards' Evoque transcatheter tricuspid valve
• Source: Edwards Lifesciences

The US Food and Drug Administration approved Edwards Lifesciences’ Evoque tricuspid valve replacement system to improve the “health status” of people with symptomatic severe tricuspid regurgitation.

The approval, announced on 1 February, makes Evoque the first FDA-approved transcatheter tricuspid replacement valve. Evoque earned FDA's breakthrough status in 2019 and a CE mark in October 2023

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Business

LSX Europe: Women’s Health Education Is The Key For Unlocking VC Investment

 
• By Natasha Barrow

Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
• By Marion Webb

Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.

Danaher Faces $350M Tariff Hit, But Says It’s Ready To Absorb The Blow

 
• By Shubham Singh

Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.

More from Medtech Insight

Danaher Faces $350M Tariff Hit, But Says It’s Ready To Absorb The Blow

 
• By Shubham Singh

Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.

Ketryx Wants Its FDA-Validated AI Agents To Accelerate Compliance Workflows

 
• By Shubham Singh

While the initial focus is medical devices and life sciences, Ketryx sees future opportunities in other high-regulation sectors including automotive, aerospace and defense, pharma manufacturing and nuclear systems.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.