Anteris Technologies Ltd's (ASX:AVR) early results from the first-in-human study of its proprietary DurAVR™ aortic valve have found that patient outcomes exceeded the results of what is normally expected following a Surgical Aortic Valve Replacement (SAVR).
The DurAVR™ valve was easy to manipulate and was able to be optimally positioned by the implanting surgeon in the aortic valve replacement procedures, promoting better results.
Lead surgeon in the study Professor Bart Meuris MD, Ph, who is chief of Cardiovascular Surgery at University Hospitals, Leuven in Belgium, presented the findings at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Conference, a world premier cardio-thoracic conference, held on October 8-10, 2020.
The data suggests that DurAVR™ when compared to other valves demonstrates the normal hemodynamic function of a healthy pre-diseased valve.
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Professor Meuris said: “These early results support the clinical hypothesis that DurAVR™, due to its anatomically correct design and the superior anti-calcification treatment of ADAPT®, will be an important addition for the treatment of severe aortic stenosis in the future.
"Its potential to offer patients a functional cure will shift treatment paradigms in the years ahead and will potentially have a significant impact on clinical practice.”
His presentation noted:
- DurAVR™ can restore normal pre-disease hemodynamics and has the potential to be a functional cure for the treatment of severe aortic stenosis;
- Patient recovery was swift, and no stay in an intensive care unit was needed;
- Ongoing development continues, including animal studies for transcatheter heart valve replacement; and
- This technology, with both surgical and transcatheter options, offers a potentially more durable solution for enhancing acute and long-term outcomes for patients with aortic valve disease.
Improved hemodynamics
Anteris chief executive officer Wayne Paterson said: "These results are extremely important because they demonstrate improved hemodynamics over currently available commercial products.
"This data is essential as we move towards further study approvals from the FDA (US Food and Drug Administration) and other regulators."
He added: “There are more patients to be recruited in this study, and we anticipate ongoing results in line with what we currently see.
"This data adds to the growing body of evidence that DurAVR™, by virtue of its unique 3D single-piece design, is delivering results that are clinically superior to what is currently available in the market."