Edwards Lifesciences ended last week with the biggest structural interventions launch that we’ve seen in some time, announcing the FDA approval of its EVOQUE transcatheter tricuspid valve replacement system (TTVR).
- The EVOQUE is the first TTVR therapy to receive FDA approval, following its European CE Mark in October.
- The TTVR system is indicated for patients with severe symptomatic tricuspid regurgitation (TR) who haven’t responded to optimal medical therapy.
The EVOQUE system features a nitinol self-expanding frame, intra-annular sealing skirt, and tissue leaflets made from the company’s bovine pericardial tissue. It will be available in three sizes, all delivered through the same low-profile transfemoral 28F system.
This design allows the EVOQUE system to replace the native tricuspid valve, “virtually eliminating tricuspid regurgitation in a wide range of patients,” and significantly improving patients’ symptoms and quality-of-life.
Those claims and the EVOQUE’s FDA approval are both supported by the recent TRISCEND II trial, which showed significant improvements after 6 months:
- 98% of EVOQUE patients improved from “severe, massive, or torrential” TR to “moderate or less,” versus just 21.6% of patients receiving optimal medical therapy.
- TTVR patients’ quality of life and functional status were also superior to medical therapy, including KCCQ scores (17.8 point avg. change), 6-minute walk tests (30.9m avg. difference), and NYHA symptoms (90% vs. 34.2% at NYHA I/II ).
- EVOQUE patients also had a lower major adverse event rate compared to Medicare patients who underwent isolated tricuspid valve replacement surgery (27.4% vs. 43.8%).
These results (and promising early data from 1-year follow-ups) suggest that EVOQUE could have a major impact on severe TR patients, who had no FDA-approved transcatheter options before now and faced challenges with surgical options.
However, other transcatheter TR therapies are available globally and could be headed stateside. Edwards also markets the Pascal and Cardioband TR valve repair systems in Europe (not yet FDA approved), and Abbott’s TriClip edge-to-edge TR repair system has a European CE Mark and has been submitted for FDA approval.
Friday could prove to be a huge day for tricuspid regurgitation treatment in the US, given the EVOQUE system’s significant impact in TRISCEND II, and the limitations of current therapies. The fact that other TR approaches might also be on the way also suggests that we could be entering a new transcatheter era in TR treatment.