Abbott & Edwards Square Off in Tricuspid RepairAbbott & Edwards Square Off in Tricuspid Repair

Abbott said the Centers for Medicare & Medicaid Services initiated a review of the TriClip National Coverage Analysis. The move comes as Abbott and Edwards are in deep competition in the tricuspid repair market.

Omar Ford

October 4, 2024

2 Min Read
Image Courtesy of Abbott Laboratories

At a Glance

  • CMS has begun a review of the device's National Coverage Analysis (NCA), with a proposed decision expected by April 2025.
  • Edwards Lifesciences' Evoque TTR system received FDA approval shortly before TriClip.
  • Both companies report strong interest in their respective tricuspid valve devices.

Abbott Laboratories moved closer to securing reimbursement for its transcatheter edge-to-edge repair (TEER) system.

The Abbott Park, IL-based company said the Centers for Medicare & Medicaid Services initiated review of the TriClip National Coverage Analysis (NCA).

Marie Thibault, an analyst with BTIG, wrote “A proposed decision memo is due by April 3, 2025, and the NCA is expected to be completed by July 2, 2025.”

TriClip uses the same clip-based technology as Abbott's MitraClip device, which is designed to treat leaky mitral valves (mitral regurgitation), but the company specifically designed TriClip to treat the tricuspid valve's complex anatomy. 

Abbott won FDA approval for the TriClip TEER System earlier this year. TriClip’s FDA approval came two months after Edwards Lifesciences obtained a nod for the Evoque TTR system. The device is a direct competitor of Abbott’s TriClip.

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Abbott’s CEO Robert Ford spoke about TriClip and its advantages over the competition.

“I think from our estimates here, even though we launched a quarter after our competitor with their system, I think the repair device is already in twice as many accounts as the replacement system, so we had a natural kind of built-in advantage here as we went to the market, and the cases are doing very well,” Ford said according to a Seeking Alpha transcript of the call. “The feedback has been very positive.”

Related:What Abbott’s Big FDA Approval Means for the Tricuspid Device Market

The Evoque TTVR system is comprised of a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from bovine pericardial tissue.

During a July earnings call, Bernard Zovighian, Edwards CEO, spoke about Evoque’s launch and the potential impact on the market.

“The Evoque commercial launch continues to progress well,” Zovighian said according to a Seeking Alpha transcript of the call. “Our disciplined strategy is focused on outstanding patient outcome in centers investing resources required to grow a successful tricuspid program. We are now opening new centers both in Europe and the US after having started with our clinical trial sites. We continue to see strong interest in the therapy, which reflects the significant unmet need in this population of patient who have few options for treatment.”

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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