Anteris Technologies (Nasdaq:AVR) today announced one-year clinical outcomes for its DurAVR transcatheter heart valve (THV).
The study evaluated DurAVR in symptomatic severe aortic stenosis patients with small aortic annuli. DurAVR demonstrated single-digit mean gradients and large effective orifice areas (EOAs). The valve also delivered no moderate or severe paravalvular leaks and no valve-related mortality at one year. The study also saw low prosthesis-patient mismatch at 30 days.
Anteris, an Australian company with a Minneapolis base in the U.S., shared its findings at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.
The pooled cohort included 65 patients with small aortic annuli implanted with DurAVR in the ongoing EMBARK study and U.S. early feasibility study.
Findings included a favorable hemodynamic profile sustained to one year, plus positive clinical safety outcomes. At 30 days, prosthesis-patient mismatch came in at 1.5%, compared to 11.2%-35.3% for concurrent commercial devices.
Anteris says that it plans to further validate the DurAVR THV in its recently initiated PARADIGM global pivotal trial.
“With small annuli patients, even minor hemodynamic inefficiencies can limit long-term outcomes, which is why optimising physiologic flow is so critical,” said Dr. Rishi Puri, coronary and structural interventional cardiologist at the Cleveland Clinic. “The latest results we are seeing with the balloon-expandable DurAVR valve are impressive, showing restoration of laminar flow, favorable hemodynamics sustained to one year, predictable deployment and a high level of procedural success across a variety of anatomies, which is exactly what we need for this patient population.”
More about Anteris and its DurAVR THV technology
Anteris designed TurAVR THV as a new class of biomimetic heart valve. The company says it’s the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped to mimic a native human aortic valve’s performance.
Balloon-expandable delivery enables precise alignment with the heart’s native commissures, achieving desired valve positioning.
The company reported a first successful implant of the valve more than two years ago. It launched an IPO in late 2024 to further advance the development of the valve. Anteris expects investigational device exemption (IDE) approval from the FDA in the near future to enable U.S. studies.
PARADIGM, approved earlier this month, compares the valve to commercial TAVR devices. Clearance for the trial in Denmark marked the first for PARADIGM. The company expects to add further countries and sites in the near-term, including in the U.S., Canada and elsewhere in Europe.
