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Edwards Lifesciences Corp.

Latest From Edwards Lifesciences Corp.

Abbott Wins FDA Approval For TriClip Repair System, Compete Against Edwards

Abbott wins FDA approval for TriClip regurgitation therapy, which will compete against Edwards Lifesciences’ recently approved Evoque transcatheter tricuspid valve replacement device. Two analysts expect Tricuspid will be eligible for a new technology add-on payment, which will be positive for Abbott.

Approvals Cardiovascular

News We're Watching: Tricuspid Procedure Boom, Boston Scientific Borrows $2Bn, And More

Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, GE Healthcare and Biofourmis announced a deal to collaborate on virtual care; Cleerly touts a new CPT code for its Ischemia cardiac diagnostic software; Boston Scientific announced how it plans to pay for Axonics; a Wells Fargo survey suggests the market for transcatheter tricuspid valve repair and replacement will grow faster than previously imagined; Virtual Incision earns FDA de novo authorization for its MIRA miniaturized surgical system for colectomy procedures; and MMI and Fabric announce major financing rounds.

News We're Watching Approvals

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

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.

Advisory Committees Cardiology

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

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.

Commercial Clinical Trials
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Company Information

  • Industry
  • Medical Devices
    • Implantable Devices
    • Infusion Therapy Equipment and Supplies
    • Monitoring Equipment & Devices
    • Surgical Equipment & Devices
  • Other Names / Subsidiaries
    • CardiAQ Valve Technologies, Inc.
    • CAS Medical Systems, Inc.
    • Embrella Cardiovascular, Inc.
    • Harpoon Medical, Inc.
    • Percutaneous Valve Technologies, Inc.
    • Valtech Cardio, Ltd.