Anteris Technologies Achieves Milestones with DurAVR® THV System
Significant One-Year Outcomes from Anteris Technologies
MINNEAPOLIS and BRISBANE, Australia – Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) has made headlines with the release of one-year patient outcomes from its innovative DurAVR® Transcatheter Heart Valve (THV) System. This pioneering medical device is designed to restore heart function with advanced technology, and the results received positive attention during a recent presentation.
Patient Outcomes Showcase Unprecedented Success
The one-year data reflected impressive results, emphasizing the durability and effectiveness of the DurAVR® THV. Notable highlights include an Effective Orifice Area (EOA) of 2.1 ± 0.2 cm², a Mean Pressure Gradient (MPG) of 8.6 ± 2.6 mmHg, and a Doppler Velocity Index (DVI) of 0.58. These metrics significantly assure patients and healthcare providers of the technological advancement behind this heart valve.
Safety and Efficacy: A New Standard
In terms of safety, the clinical outcomes revealed no valve or cardiovascular-related mortality among the patients at one year. Importantly, there was zero report of prosthesis-patient mismatch (PPM), a common concern in small annuli patients. Traditional commercial devices generally report PPM rates ranging from 11.2% to 35.3%, a crucial predictor of valve failure that can significantly affect patient outcomes.
Expert Insights on DurAVR®’s Performance
Chris Meduri, M.D., Chief Medical Officer at Anteris, expressed optimism about the one-year data. He stated, "The results continue to validate the revolutionary hemodynamic performance of DurAVR® THV. This valve stands out for demonstrating zero PPM in small annuli patients, an achievement that significantly enhances the long-term outlook for patients." This statement brings hope for long-term effectiveness and showcases the development’s potential to reshape treatment protocols.
Clinical Success with DurAVR® THV System
As part of the clinical program, sixty-five patients completed the primary endpoint measure at 30 days, with high implant success rates. The consistency in safety profiles reinforces trust in the innovative valve technology. The patient outcomes mark a significant step forward as Anteris prepares for pivotal trials in the future.
Moving Forward: Regulatory Path and Future Trials
The promising one-year results will be leveraged for an Investigational Device Exemption (IDE) submission to the U.S. FDA. Anteris aims to gain approval for conducting randomized, global pivotal studies for the DurAVR® THV System, bringing even more attention to its potential to revolutionize transcatheter heart valve treatments.
About Anteris Technologies
Founded in Australia, Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is committed to developing state-of-the-art medical devices for heart restoration. The company’s lead product, DurAVR® THV, is specially designed to mimic the natural function of a healthy aortic valve, addressing life-threatening conditions like aortic stenosis. With its patented ADAPT® tissue technology, the DurAVR® system has already served over 55,000 patients worldwide, showcasing a strong commitment to patient health and innovation.
Frequently Asked Questions
What are the key outcomes of the one-year data for DurAVR® THV?
The one-year data includes an Effective Orifice Area (EOA) of 2.1 ± 0.2 cm² and zero occurrences of prosthesis-patient mismatch (PPM), enhancing safety and efficacy.
Who presented the one-year results, and where was it announced?
Rishi Puri, M.D., PhD, presented the one-year outcomes during a clinical trial session at Sydney Valves.
How does DurAVR® THV differ from traditional valves?
DurAVR® THV is the first biomimetic valve, designed to replicate the natural aortic valve function, leading to improved blood flow dynamics.
What are the future plans for DurAVR® THV?
Anteris plans to use one-year data for an IDE submission to seek approval for conducting pivotal trials essential for regulatory considerations.
How can I contact Anteris Technologies for more information?
For inquiries, you can reach Anteris at +61 1300 550 310 or visit their website at www.anteristech.com. Investor relations can be contacted at investor@anteristech.com.
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