Anteris DurAVR THV FIH Study Provides New Cardiac MRI Data

June 11, 2024—Anteris Technologies Ltd. announced new data for the company’s DurAVR transcatheter heart valve (THV), a balloon-expandable, single-piece biomimetic device shaped to mimic the native human valve for transcatheter aortic valve replacement (TAVR).

João Cavalcante, MD, presented cardiac MRI data from the DurAVR THV first-in-human (FIH) study showing the restoration of normal flow and hemodynamics, leading to significant left ventricular (LV) mass regression in patients with symptomatic, severe aortic stenosis (AS), stated the Anteris press release.

Dr. Cavalcante, Section Head of Cardiac Imaging at Allina Health Minneapolis Heart Institute and Scientific Director of the Cardiovascular Imaging Core Lab and Research Center in Minneapolis, Minnesota, presented the study at New York Valves 2024: The Structural Heart Summit held June 5-7 in New York, New York.

According to the company, DurAVR THV demonstrated excellent postprocedure hemodynamic results in 41 patients, with large effective orifice areas (2.20 cm²), single-digit mean gradients (8.5 mm Hg), and a Doppler Velocity Index (DVI) of 0.62. These hemodynamic results resemble those seen in healthy patients.

Dr. Cavalcante further reported that the DurAVR THV restored laminar flow with near equivalence to a normal healthy aortic valve, in which there is little-to-no flow displacement (FD), the flow is noneccentric, and there is limited-to-no flow reversal (FRR) even in systole.

Using cardiac MRI data from Pankaj Garg, MBBS, the flow data for DurAVR THV (n = 11) was FD = 15%, FRR = 5%. This was compared with a normal healthy aortic valve (n = 5; FD = 10%, FRR = 1%) and in severe AS (FD = 46%, FRR = 23%). The press release noted that studies performed on commercially available TAVR devices—balloon-expandable or self-expanding—do not appear to restore normal aortic flow.

“When we look at commercially available surgical or TAVR valves, we are still seeing abnormal flow patterns on cardiac MRI,” commented Dr. Cavalcante in the Anteris press release. “The restoration of laminar flow, as we are seeing with this new DurAVR THV, is a byproduct of the intrinsic valve design and novel technology, which might have positive downstream implications to the arteries and consequently to ventricle, and ultimately to the patients.”

Dr. Cavalcante also reported that in patients treated with DurAVR THV, cardiac MRI detected a significant LV mass index regression at 6 months after TAVR. He noted that a meta-analysis of other TAVR platforms demonstrated an average LV mass index regression of approximately 15 g/m² (Mehdipoor et al, Journal of Cardiovascular Magnetic Resonance). DurAVR THV showed a difference of approximately 20 g/m².

The full downstream effect of restoring laminar flow will need to be further studied and validated in ongoing and future studies, including a larger pivotal imaging substudy, advised the Anteris press release.