Anteris Technologies has announced that the US Food and Drug Administration (FDA) has conditionally approved its DurAVR transcatheter heart valve system for an investigational device exemption (IDE) application to commence an early feasibility study (EFS).
DurAVR is a balloon-expandable, 3D single-piece aortic valve, which is shaped to mimic the native human valve.
The EFS study will evaluate the safety and feasibility of the device in the treatment of subjects with symptomatic severe native aortic stenosis (AS). The FDA concluded the company provided adequate data to support the initiation of a clinical study in the USA, Anteris Technologies said in a press release. The EFS will enrol 15 subjects at seven heart valve centres of excellence within the USA. It is anticipated the study will commence in early 2023, paving the way for a pivotal, registration AS trial in the first half of 2024.
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 haemodynamic 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 categorised DurAVR in this study as a Centers for Medicare & Medicaid Services (CMS) category B device, which permits the device to be sold during the study pending CMS approval.
“I am pleased and eager to begin the DurAVR transcatheter heart valve EFS to further evaluate this promising novel technology. The single piece, native-shape valve design of the DurAVR transcatheter heart valve represents an advancement to existing heart valve technologies. I am excited to see the potential of the DurAVR transcatheter heart valve in treating patients suffering from severe aortic stenosis,” stated Michael Reardon (Houston Methodist Hospital, Houston, USA), study chair for the DurAVR EFS.
The DurAVR THV System is limited for investigational use only.