Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has successfully completed enrolment for its Early Feasibility Study (EFS), approved by the US Food and Drug Administration, to evaluate DurAVR™ THV.
This unique device represents a new class of biomimetic valve and stands as the world's only balloon-expandable, single-piece transcatheter aortic valve.
The EFS is a critical phase in obtaining FDA clearance for commercialisation in the United States.
“We are pleased with the excellent outcomes we have seen in the Study and we look forward to sharing the results. The data has the potential to change the treatment paradigm for Severe Aortic Stenosis Patients,” Anteris Chief Medical Officer Dr. Chris Meduri said.
Assessing safety and feasibility
The study aims to assess the safety and feasibility of DurAVR™ THV in treating 15 patients suffering from symptomatic, severe native aortic stenosis (AS).
“The completion of the 15 patient EFS enrolment marks another major milestone in the company’s progress towards commercial approval,” Anteris CEO Wayne Paterson said.
“With outstanding results attributable to DurAVRTM’s unique first in class biomimetic design, the product has proven its clinical viability. The Company is extremely grateful to the physicians and patients who participated in this Study.”
Leading the study are Dr Azeem Latib, Director of Interventional Cardiology and Structural Heart Interventions at Montefiore Health System in New York, and Dr Gorav Ailawadi, Chairman and Helen F. and Marvin M. Kirsh Professor of Cardiac Surgery at the University of Michigan. Dr Mike Reardon, Chair of Cardiovascular Research at the Houston Methodist De Bakey Heart and Vascular Centre, serves as the Study chair.
Dr Latib said, “I am enthused to note the post-procedure patient outcomes seen in US patients not only corroborated with data reported from previous cohorts but exceeded them. The ability to use this device with such excellent haemodynamic results, as well as ease of use, is incredible progress in the treatment of patients with severe aortic stenosis.”
Data regarding patient discharge and 30-day outcomes will be released following comprehensive collation and analysis.