Anteris Technologies' DurAVR® Transcatheter Valve Shows Strong One-Year Performance, Paving the Way for Next Steps

3 min read | March 21, 2025 11:29 AM AEDT | By Team Kalkine Media

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Anteris Technologies' DurAVR® Transcatheter Valve Shows Strong One-Year Performance, Paving the Way for Next Steps — Image source: shutterstock

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Highlights

DurAVR® THV continues to demonstrate exceptional durability and hemodynamic performance.

No cases of prosthesis-patient mismatch (PPM) were observed, a key factor in valve success.

The findings will support Anteris Technologies' (AVR) upcoming regulatory submission to the FDA.

Anteris Technologies (ASX:AVR) has unveiled positive one-year clinical data for its proprietary DurAVR® Transcatheter Heart Valve (THV) System, reinforcing its potential as a next-generation solution for patients with structural heart disease.

The latest findings highlight the system’s durability, safety, and groundbreaking hemodynamic performance. These results, which will be presented at the Sydney Valves Conference on March 21, 2025, further strengthen the company's commitment to advancing innovative treatments for cardiovascular conditions.

Exceptional Hemodynamic Performance & Safety

Clinical data continues to demonstrate that DurAVR® THV offers a superior hemodynamic profile, maintaining an Effective Orifice Area (EOA) of 2.1 cm², a Mean Pressure Gradient (MPG) of 8.6 mmHg, and a Doppler Velocity Index (DVI) of 0.58.

One of the most notable takeaways from the study is the complete elimination of prosthesis-patient mismatch (PPM) in small annuli patients. This sets DurAVR® THV apart from existing commercial devices, which report PPM rates between 11.2% and 35.3%—a key predictor of valve failure and disease progression.

Anteris Technologies' Chief Medical Officer, Dr. Chris Meduri, emphasized the importance of this breakthrough, stating,
"PPM is a well-known challenge in transcatheter aortic valve replacement (TAVR). The ability of DurAVR® to completely eliminate PPM in small annuli patients is a significant advancement that can positively impact long-term outcomes."

Additionally, the safety profile of DurAVR® THV remains strong, with no reported valve-related or cardiovascular mortality. The system has demonstrated high implant success rates, further supporting its clinical potential.

Pathway to Regulatory Approval

With 65 patients having completed the primary endpoint measure at 30 days, Anteris Technologies (AVR) is now gearing up for its next phase of regulatory submissions. The one-year results will be incorporated into the company's Investigational Device Exemption (IDE) submission to the U.S. Food and Drug Administration (FDA).

Securing this approval would allow Anteris Technologies to move forward with a randomized, global pivotal trial, a crucial step toward bringing DurAVR® THV to a broader patient population.

These latest findings mark another milestone for Anteris Technologies, reinforcing its commitment to innovation in structural heart solutions. As the company advances its regulatory journey, the success of DurAVR® THV continues to position it as a leading contender in next-generation transcatheter valve technology.

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