Anteris Technologies Global Corp. (AVR) announced that the first U.S. patients have been treated in its global pivotal PARADIGM trial evaluating DurAVR, the company's next-generation transcatheter heart valve designed to restore natural valve function in patients with severe symptomatic aortic stenosis.
The PARADIGM study is a multicenter, prospective, single-arm pivotal trial intended to support regulatory submissions in the United States and other global markets. The trial will enroll patients with severe aortic stenosis who are candidates for transcatheter aortic valve replacement (TAVR). Investigators will assess safety and performance outcomes, including valve function, hemodynamics, and clinical improvement following implantation.
DurAVR is engineered with a unique single-piece, 3D-shaped leaflet design intended to mimic the natural motion of a healthy aortic valve. Early clinical experience from prior studies has shown promising hemodynamic performance, including low gradients and large effective orifice areas, which may translate into improved long-term durability.
The company noted that treating the first U.S. patients marks a significant milestone in the global development of DurAVR and reflects growing clinical adoption across multiple regions. Additional sites in the U.S., Europe, and Australia are expected to continue enrolment throughout 2026.
AVR has traded between $2.85 and $6.95 over the past year. The stock closed Monday's trading at $6.13, down 3.62%. In pre-market trading the stock is at $6.20, up 1.14%.
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