Anteris Reports Medium-Size DurAVR THV Outcomes from the EMBARK Study at TCT 2026
Key Highlights
- ➤Medium-size DurAVR THV delivered 2.64 cm² EOA versus 0.8 cm² baseline
- ➤30-day mean pressure gradient fell to 6.17 mmHg from 45.5 mmHg baseline
- ➤22 patients showed no valve-related mortality or moderate/severe paravalvular leak
- ➤100% freedom from moderate/severe prosthesis-patient mismatch at 30 days
- ➤PARADIGM pivotal trial plans approximately 1,000 randomized patients
Expert Statements
Chris Meduri, M.D., Chief Medical Officer of Anteris
“These are exceptional 30-day hemodynamics for medium annuli, with large effective orifice areas, single-digit gradients, and no moderate or severe PPM or paravalvular leak. That matters because prosthesis-patient mismatch is not just a small-annulus problem. A recent study in younger, lower-risk TAVR patients found PPM was associated with higher mortality and substantially more heart failure hospitalization at five years.¹ As TAVR moves to patients who will live with their valve for decades, this is the hemodynamic profile we designed DurAVR to deliver, and we look forward to PARADIGM confirming it in a randomized setting.”
MINNEAPOLIS and BRISBANE, Australia, Nov. 01, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced 30-day clinical and hemodynamic outcomes for the Medium-size DurAVR(®) Transcatheter Heart Valve (THV) in twenty-two severe aortic stenosis patients with medium aortic annuli (aortic annulus area 492 ± 38 mm(2)). The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 100% freedom from moderate or severe prosthesis-patient mismatch(*) (PPM) in a cohort of medium annuli patients from the EMBARK Study.
The 30-day Medium-size DurAVR THV results were presented by Azeem Latib, MD during the Emerging Concepts and Innovations in TAVR session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego, California.
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