Anteris Begins US Enrollment for DurAVR Tissue-Engineered Stentless Aortic Valve Trial
Anteris Technologies has treated the first US patients with its DurAVR tissue-engineered stentless aortic valve in the pivotal trial. The study will assess the device’s durability and safety to support FDA approval for treating severe aortic stenosis.
1. First US Patient Treatment
Anteris Technologies reported treatment of its first US patients with DurAVR at participating centers in the pivotal study. This milestone marks the start of US enrollment after earlier international cohorts and represents a key step toward clinical validation.
2. Trial Design and Objectives
The multicenter pivotal trial will evaluate DurAVR’s durability and safety in patients with severe symptomatic aortic stenosis across defined follow-up intervals. Positive outcomes are intended to support a premarket approval application, potentially expanding commercial opportunities for the tissue-engineered stentless valve.