Structural heart company Anteris Technologies Ltd (ASX: AVR) has been granted expanded approval by the United States Food and Drug Administration (FDA) for the DurAVR THV System in Subjects with Severe Aortic Stenosis: Early Feasibility Study (EFS).
The expanded approval removes the previous conditions placed on the study and will allow Anteris to accelerate certain activities related to study execution. Specifically, approval by the Centers for Medicare & Medicaid Services will finalise the reimbursement level under the Category B designation previously granted by the FDA.
The DurAVR THV System is a new class of ‘biomimetic’ aortic heart valve replacement device and the world’s first single-piece transcatheter heart valve, made with the company’s patented ADAPT anti-calcification process and innovative tissue-shaping technology. The EFS will evaluate the safety and feasibility of the DurAVR THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
The DurAVR THV clinical programme continues to gather significant momentum with the removal of conditions by the FDA further paving the way for our ground-breaking technology,” CEO, Wayne Paterson, said.
“We are excited to continue building our remarkable real-world evidence base amongst patients receiving DurAVR in the United States as we progress on our path to regulatory approval.”
About Anteris
Anteris Technologies Ltd is a structural heart company that delivers clinically superior and durable solutions through better science and better design.
Its focus is developing next-generation technologies that help healthcare professionals deliver consistent life-changing outcomes for patients.
Anteris’ DurAVR 3D single-piece aortic heart valve replacement addresses the needs of today’s younger and more active aortic stenosis patients by delivering superior performance and durability through innovations designed to last the remainder of a patient’s lifetime.
The proven benefits of its patented ADAPT tissue technology, paired with the unique design of the company’s DurAVR 3D single-piece aortic heart valve, have the potential to deliver a game-changing treatment to aortic stenosis patients worldwide and provide a much-needed solution to the challenges facing doctors today.
