Medium-size DurAVR THV delivers single digit gradients in EMBARK Study at TCT 2026
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) reported 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 mm²). The data come from the EMBARK Study.
The company said the valve demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality. It also reported 100% freedom from moderate or severe prosthesis-patient mismatch (PPM).
Azeem Latib, MD, presented the results during the Emerging Concepts and Innovations in TAVR session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego, California. The medium annuli cohort adds to the evidence base for the DurAVR THV across valve sizes.
When big ASX news breaks, our subscribers know first
30-day results at a glance
The two hemodynamic measures reported for the cohort moved sharply from baseline to 30 days.
| Measure | Baseline | 30 days | Change in context |
|---|---|---|---|
| Effective orifice area (EOA) | 0.8 ± 0.2 cm² | 2.64 ± 0.19 cm² | Reported as a large EOA |
| Mean pressure gradient (MPG) | 45.5 ± 11.7 mmHg | 6.17 ± 1.40 mmHg | Reported as a single digit gradient |
Clinical safety outcomes at 30 days were described by the company as positive:
- No valve related mortality
- No moderate or severe paravalvular leak (PVL)
- No moderate or severe PPM observed at 30 days
Chris Meduri, M.D., Anteris Chief Medical Officer
“…prosthesis-patient mismatch is not just a small-annulus problem… 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…”
Why prosthesis-patient mismatch matters to investors
PPM happens when a prosthetic valve, after being implanted, does not have a large enough opening (EOA) to accommodate the patient’s blood flow needs, based on their body size. The result is higher than expected gradients, meaning more pressure across the valve.
According to the announcement, PPM affects a significant proportion of transcatheter aortic valve replacement (TAVR) patients, particularly those with a small aortic annulus. It has also been associated with impaired long-term survival following surgical aortic valve replacement (SAVR).
The company cited a 2025 study by Suruga et al. in JACC Cardiovasc Interv. In younger, lower-risk TAVR patients, PPM was associated with higher mortality and substantially more heart failure hospitalization at five years.
For investors, durable hemodynamics is central to the case Anteris makes for DurAVR as TAVR moves to patients who will live with their valve for decades. The current results come from 22 patients at 30 days.
PARADIGM pivotal trial is the next step
The DurAVR THV is being evaluated in the ongoing global PARADIGM pivotal trial (ClinicalTrials.gov ID NCT07194265), which is actively enrolling patients. The trial will include use of the Medium-size DurAVR THV.
Medicare reimbursement eligibility under a CMS Coverage with Evidence Development framework lets US hospitals bill for DurAVR procedures during the trial, removing a major financial barrier to site participation.
Key design features of the trial:
- Prospective randomized controlled trial
- Approximately 1,000 patients in the ‘All Comers Randomized Cohort’
- 1:1 randomization to the DurAVR THV or commercially available and approved THVs
- Non-inferiority assessed on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure
Anteris describes the balloon-expandable DurAVR THV as the first biomimetic valve, shaped to mimic the performance of a healthy human aortic valve. It is made from a single piece of molded ADAPT tissue, which is FDA-cleared, has been used clinically for over 10 years and has been distributed for use in over 55,000 patients worldwide.
The DurAVR THV System also includes the balloon-expandable ComASUR Delivery System. The DurAVR THV is intended for INVESTIGATIONAL USE ONLY and is not available for commercial use or sale worldwide.
For readers wanting to follow the European rollout, our full explainer on the French ANSM clearance for PARADIGM covers how France joins the US in active enrolment and what that means for diversifying execution risk across the trial.
Don’t Miss the Next Healthcare Breakthrough
Join 20,000+ investors getting FREE breaking ASX news delivered to their inbox within minutes of release, complete with in-depth analysis. Click the “Free Alerts” button at Big News Blast to get healthcare and medtech updates the moment market-moving announcements break.