November 16, 2025
DurAVR® THV Clinical Data Update at London Valves 2025
At London Valves, Prof. Ole De Backer presented 30-day data from 100 small annuli patients treated with DurAVR® THV in the EMBARK and EFS studies.
Highlights of 30-Day Results for 100 Small Annuli Patients Implanted with the DurAVR® THV
- DurAVR® THV delivered a favorable hemodynamic profile with a large EOA of 2.2 ± 0.3 cm2, a single digit mean pressure gradient (MPG) of 8.2 ± 3.1 mmHg.
- At 30 days, clinical safety outcomes were positive with no valve-related mortality and no moderate or severe paravalvular leak (PVL).
- 97% freedom from moderate or greater prosthesis-patient mismatch*
- A technical success rate** of 100% was achieved in the last 50 consecutive patient implants
*Prosthesis‐patient mismatch (PPM) happens when a prosthetic valve, after being implanted, doesn't have a large enough opening (EOA) to accommodate the patient's blood flow needs, based on their body size. The result is higher than expected gradients. PPM affects a significant proportion of transcatheter aortic valve (TAVR) patients, particularly patients with a small aortic annulus and has been associated with impaired long-term survival following surgical aortic valve replacement (SAVR).
**As defined in VARC-3.