FDA Okays Early Feasibility Study for Anteris’ TAVR Product

Anteris Technologies Ltd. has received U.S. Food and Drug Administration (FDA) conditionally approval to begin an early feasibility study of its DurAVR Transcatheter Heart Valve (THV;TAVR) System.
 
The study will evaluate the safety and feasibility of DurAVR in treating patients with symptomatic severe native aortic stenosis (AS). The trial will enroll 15 subjects at seven U.S. Heart Valve Centers of Excellence and will eventually help the company sponsor a pivotal, registration AS trial in the first half of 2024.

“I am pleased and eager to begin the DurAVR THV EFS to further evaluate this promising technology. The single piece, native-shape valve design of the DurAVR THV represents an advancement to existing heart valve technologies. I am excited to see the potential of the DurAVR THV in treating patients suffering from severe aortic stenosis,” stated Dr. Michael Reardon, study chair and Allison Family Distinguished Chair in Cardiovascular Research, Department of Cardiovascular Surgery, professor of Cardiovascular Surgery, Houston Methodist Hospital.
 
The primary and key secondary endpoints of this trial include safety and device feasibility assessments such as success of implantation at the anatomically accurate position, and hemodynamic performance assessments including effective orifice area (EOA), mean gradient, aortic regurgitation, paravalvular leak (PVL) and Doppler Velocity Index (DVI). Patient outcomes such as stroke, myocardial infarction, life-threatening bleeds, and all-cause mortality are to be reported at 30 days, three months, and one-year post implantation.
 
The FDA has categorized DurAVR in this study as a CMS Category B device, which permits the device to be sold during the study pending CMS approval.
 
“The FDA approval to begin the DurAVR EFS is a critical milestone for Anteris achieving pre-market approval in the United States. It is also another validation of the remarkable work done so far. This study will build upon clinical data from the DurAVR First-in-Human Study recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston and London Valves in London, England. I am extremely proud of the entire Anteris Team for achieving this milestone in the clinical development of the DurAVR THV System,” Anteris Technologies Chief Medical Officer Dr. Chris Meduri said.
 
“This study sets up 2023 to be a significant year of milestones and catalysts as we continue to build our remarkable base of evidence amongst patients who have had DurAVR implanted. In the next year, we will significantly expand the patient population implanted with DurAVR, a new class of valve made with a first-in-class, single-piece, native-like valve design built upon our breakthrough ADAPT tissue treatment that has years of real world experience,” Anteris Technologies CEO Wayne Paterson said. 
 
DurAVR THV System is an investigational device, limited by federal law for investigational use only.
 
Anteris Technologies Ltd. is a structural heart company 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 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.