- Anteris Technologies (AVR) receives conditional US FDA approval for the DurAV Transcatheter Heart Valve (THV) system to commence an early feasibility study (EFS)
- The FDA concluded that Anteris, who applied for an investigational device exemption (IDE), provided adequate data to support the initiation of a clinical study in the US
- The study will evaluate the safety and feasibility of the THV system in treating symptomatic severe native aortic stenosis in 15 subjects
- The early feasibility study is scheduled to begin in early 2023
- Shares in Anteris last traded at $23 each at 11:55 am AEDT
Anteris Technologies (AVR) has received conditional US FDA approval for the DurAV Transcatheter Heart Valve (THV) system to commence an early feasibility study (EFS).
The company applied for an investigational device exemption (IDE) to commence the study which will evaluate the safety and feasibility of the THV system in treating symptomatic severe native aortic stenosis.
The Food and Drug Administration (FDA) concluded that Anteris provided adequate data to support the initiation of a clinical study in the US.
The EFS will enroll 15 subjects at seven heart valve centres within the US, anticipated to commence in early 2023.
Chief Medical Officer Chris Meduri called the approval a critical milestone for Anteris achieving pre-market approval in the US.
“It is also another validation of the remarkable work done so far,” Dr Meduri said.
“This study will build upon clinical data from the DurAV First-in- Human Study recently presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston US and London Valves in London, England.”
The FDA has categorised DurAVR in this study as a Centres for Medicare and Medicaid (CMS) Category B device which permits the device to be sold during the study pending CMS approval.
The system is an investigational device, limited by federal law for investigational use only.
“Anteris has planned to significantly expand the patient population implanted with DurAVR in 2023,” CEO Wayne Paterson stated.
Shares in Anteris last traded at $23 each at 11:55 am AEDT.