Anteris reports 30‑day results for medium‑size DurAVR heart valve in 22 patients
Anteris Technologies announced 30‑day clinical and hemodynamic outcomes for its medium‑size DurAVR transcatheter heart valve in a cohort of 22 severe aortic stenosis patients with medium aortic annuli. The valve showed a mean pressure gradient of about 6.2 mmHg, an effective orifice area of roughly 2.64 cm², and no cases of moderate or severe paravalvular leak, prosthesis‑patient mismatch, or valve‑related death. The data were presented at the TCT conference and will be incorporated into the ongoing PARADIGM pivotal trial.
Why it matters
The company says the early safety and performance results support the design goals of DurAVR and bolster expectations for the upcoming PARADIGM trial, which will determine whether the valve can achieve regulatory clearance and market adoption. Investors may view the data as a positive signal for future revenue potential, though no immediate financial impact is disclosed.
Key facts
- 1The study enrolled 22 patients with severe aortic stenosis and medium aortic annuli. stocktitan.net
- 2The aortic annulus area of the cohort was 492 ± 38 mm². stocktitan.net
- 3Mean pressure gradient at 30 days was 6.17 ± 1.40 mmHg, down from a baseline of 45.5 ± 11.7 mmHg. stocktitan.net
- 4Effective orifice area increased to 2.64 ± 0.19 cm² from a baseline of 0.8 ± 0.2 cm². stocktitan.net
- 5There were no valve‑related deaths, no moderate or severe paravalvular leak, and no moderate or severe prosthesis‑patient mismatch observed at 30 days. stocktitan.net
- 6The results were presented by Dr Azeem Latib at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego. mykxlg.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.