Anteris Technologies Ltd (ASX:AVR) has implanted its proprietary DurAVR™ Transcatheter Heart Valve into the first three animals as part of a transcatheter aortic valve replacement (TAVR) study.
The first feasibility study in pigs aims to confirm DurAVR™ valve deployment and fixation (anchoring) as well as providing insight into the valve’s haemodynamic function.
Anteris chief executive officer and managing director Wayne Paterson said: “The DurAVR™ valve continues to deliver superior performance observed to date.
“This preclinical study provides encouraging data and, importantly, will inform our development program and product design fine-tuning.”
The study of nine animals is being conducted in Minneapolis, USA, and is scheduled to be completed by December 31, 2020.
Value function measured
The three pigs were implanted with a 25-millimetre valve via a catheter by a trans-apical approach.
The Effective Orifice Areas (EOA) were 2.45 centimetres squared on initial readings, consistent with the positive results observed in patients surgically implanted in the first-in-human SAVR clinical study and in previous animal and laboratory studies of the DurAVR™ valve.
The EOA, a measurement of haemodynamic function, is a significant indicator of valve function and performance.
Significance of the study
The study replicated the findings of the 3D single-piece DurAVR™ aortic valve as shown in the surgical aortic valve replacement (SAVR) animal study and, thus far, in the first-in-human SAVR clinical study of the DurAVR™ valve underway at the University Hospitals, Leuven in Belgium.
This early feasibility study is critical as the company moves toward the next phase of development.
The lessons learned in this study will allow Anteris to make refinements to the frame and delivery system for the DurAVR™ aortic valve, which ultimately will be applied to the device used in the planned US FDA submission for a human clinical trial in 2021.