Anteris Technologies Global Corp (ASX: AVR) Reports Positive One-Year DurAVR™ Clinical Data

Anteris Technologies Global Corp (ASX: AVR, NASDAQ: AVR) has announced positive one-year clinical data for its DurAVR™ Transcatheter Heart Valve. The data highlights zero valve-related mortality and favourable Anteris Technologies DurAVR valve hemodynamics in patients with small aortic annuli. This ASX announcement details outcomes that position the company’s biomimetic valve technology as a notable development in the transcatheter aortic valve replacement (TAVR) market.

The global structural heart company reported outcomes from 65 patients with small aortic annuli, indicating a 1.5% prosthesis-patient mismatch rate. This compares to a range of 11.2% to 35.3% reported for existing commercial devices. These results stem from pooled data across the ongoing EMBARK Study and US Early Feasibility Study, providing further evidence for the DurAVR™ valve’s hemodynamic profile ahead of the recently initiated PARADIGM pivotal trial. This investor update provides an overview of the key findings.

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What are the Reported One-Year Clinical Outcomes for DurAVR™?

The one-year clinical data indicates positive safety and performance metrics across several critical parameters for DurAVR™ valve patients with small aortic annuli. The results suggest the valve’s capacity to deliver sustained hemodynamic efficiency in a challenging patient population.

Key Safety Outcomes:

• Zero valve-related mortality reported at one year.
• No moderate or severe paravalvular leaks detected.
• High procedural success rates across various anatomies were observed.
• A sustained safety profile was maintained throughout the 12-month follow-up period.

Hemodynamic Performance Data:

• Effective Orifice Area (EOA): 2.1 ± 0.2 cm²
• Mean Pressure Gradient (MPG): 8.6 ± 2.6 mmHg
• A sustained favourable hemodynamic profile was observed throughout the 12-month period.
• Single-digit mean gradients were reported, indicating minimal flow obstruction.

The study cohort included 65 patients with small aortic annuli (aortic annulus area 396 ± 37 mm²). This group represents a patient population often considered challenging in structural heart interventions. Furthermore, the clinical outcomes noted in over 100 patients implanted with the DurAVR™ THV offer encouraging evidence for broader clinical consideration.

Dr. Rishi Puri, Coronary and Structural Interventional Cardiologist at the Cleveland Clinic, commented: “The latest results observed with the balloon-expandable DurAVR™ valve are notable, indicating restoration of laminar flow, favourable hemodynamics sustained to one year, predictable deployment, and a high level of procedural success across a variety of anatomies.”

How May Prosthesis-Patient Mismatch Affect Small Annuli Patients?

Prosthesis-patient mismatch (PPM) in small annuli patients represents a significant clinical consideration in transcatheter aortic valve replacement. The Anteris Technologies DurAVR valve hemodynamics are particularly relevant in addressing this issue.

Understanding Prosthesis-Patient Mismatch:

PPM occurs when an implanted prosthetic valve provides an opening size (effective orifice area) that is less than optimal relative to a patient’s blood flow requirements based on their body size. This condition can lead to higher than anticipated pressure gradients and reduced hemodynamic efficiency, which may influence long-term outcomes.

Risk Factors for Small Annuli Patients:

• Limited anatomical space can restrict valve size options and deployment flexibility.
• Conventional valves may present trade-offs between deliverability and performance.
• Even minor hemodynamic inefficiencies can become more pronounced in smaller anatomical spaces.
• Long-term survival implications have been documented in surgical aortic valve replacement.

The 1.5% PPM rate reported for DurAVR™ indicates a significant difference when compared to current commercial devices, which typically report PPM rates ranging from 11.2% to 35.3% in similar patient populations. This reduction addresses a key factor associated with valve performance.

Clinical Relevance:

• PPM may affect a proportion of TAVR patients.
• Small aortic annulus patients may face a higher relative risk.
• PPM has been linked with impaired long-term survival following surgical aortic valve replacement.
• Optimising physiological flow is considered important for patient outcomes.
• A reduction in PPM rates may contribute to improved long-term clinical benefits.

Dr. Puri reiterated: “With small annuli patients, even minor hemodynamic inefficiencies can limit long-term outcomes, which is why optimising physiological flow is so critical.”

What Contributes to DurAVR™’s Favourable Hemodynamic Performance?

The Anteris Technologies DurAVR valve hemodynamics are attributed to its biomimetic design approach and proprietary ADAPT® tissue platform. These features differentiate it from conventional transcatheter heart valves through reported clinical data.

Biomimetic Design Approach:

The DurAVR™ THV is designed to mimic the performance of a healthy human aortic valve, aiming to replicate normal aortic blood flow patterns. This design approach seeks to address limitations in traditional prosthetic valve designs by promoting laminar flow characteristics.

ADAPT® Tissue Technology:

• Features single-piece moulded construction utilising patented anti-calcification tissue technology.
• Is FDA-cleared with over 10 years of clinical use.
• Has been distributed for use in over 55,000 patients worldwide.
• Reports a track record of safety and durability across diverse patient populations.

System Components:

The DurAVR™ THV System comprises three integrated elements:

1. DurAVR™ valve – biomimetic design intended for physiological flow.
2. ADAPT® tissue – anti-calcification technology platform.
3. ComASUR™ Delivery System – balloon-expandable deployment mechanism.

Performance Characteristics Noted:

• Single-digit mean gradients (8.6 ± 2.6 mmHg) indicating minimal flow obstruction.
• Large effective orifice areas (2.1 ± 0.2 cm²) supporting hemodynamic function.
• Restoration of laminar flow potentially improving physiological performance and reducing turbulence.
• Predictable deployment which may reduce procedural considerations and support positive outcomes.

Furthermore, the technology demonstrates versatility across various anatomies. This addresses a key consideration for current TAVR devices that may encounter challenges with complex anatomical presentations. The predictable deployment characteristics are intended to assist physicians in achieving consistent results across diverse patient populations.

How Does DurAVR™ Performance Compare to Commercial TAVR Devices?

The clinical data reveals differentiation for the Anteris Technologies DurAVR valve hemodynamics when compared against established commercial transcatheter aortic valve replacement devices in small annuli patient populations.

Prosthesis-Patient Mismatch Comparison:

The reported difference is evident in prosthesis-patient mismatch rates. DurAVR™ indicated a 1.5% PPM rate at 30 days, compared with 11.2% to 35.3% for current commercial devices. This represents a reduction of approximately seven to twenty-three fold, depending on the comparative device.

Hemodynamic Profile:

The sustained hemodynamic profile at one year indicates:

• Consistent effective orifice areas maintained throughout follow-up.
• Stable mean pressure gradients without reported deterioration over time.
• Zero moderate or severe paravalvular leaks reported, suggesting effective sealing.
• Restoration of laminar flow patterns approximating natural valve function.

Safety Profile Observations:

Furthermore, the safety outcomes include:

• Zero valve-related mortality at one year.
• No moderate or severe paravalvular leak throughout follow-up.
• High procedural success rates across various anatomies.
• Predictable deployment possibly reducing the operator learning curve.

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