1. Medtech Insight
  2. >>Device Area
  3. >>Cardiology

FDA AdCom Will Scrutinize Placebo Benefit Of Abbott’s TriClip G4 TTVR

 
• By Reed Miller

An FDA advisory panel will discuss Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device on 13 February. The group’s discussion will likely focus on the lack of a clear mortality or hospitalization benefit in the TRILUMINATE pivotal trial.

MT2007_FDA Advisory Comm_292512269_1200.jpg

[Editor's Note: At its 14 February meeting, FDA's circulatory system devices panel voted nearly unanimously in favor of Abbott's TriClip G4, including a 13-1 vote in favor of concluding that the benefits of the technology outweigh its risks. Medtech Insight will have more on TriClip G4 later this week.]

Analysts expect the US Food and Drug Administration to approve Abbott ’s TriClip G4 transcatheter tricuspid valve repair (TTVR) system,

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 Cardiology

More from Device Area

AAOS 2025 Orthopedic Roundup: J&J Velys UKA, Stryker Mako 4, Materialise, Canary Medical

 
• By Marion Webb

At AAOS, orthopedics players showcased their latest robotic-assisted platforms, power tools, 3D printed technologies and software offerings. This article brings you highlights from interviews Medtech Insight conducted on site with representatives from J&J, Stryker, Materialise and Canary Medical.

Abbott Embeds Libre Glucose Data In Epic EHR, Expanding Digital Health Footprint

 
• By Shubham Singh

Through this partnership, data stored in LibreView – Abbott’s cloud-based diabetes data management system – can automatically flow into Epic, allowing clinicians using Epic to view a patient’s CGM data before, during and after visits without toggling between systems or requesting manual uploads.

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 
• By Natasha Barrow

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.