Anteris DurAVR® THV Demonstrates Favorable Hemodynamics in Small Annuli Patients with no Valve Related Mortality at One Year
Anteris (NASDAQ: AVR) reported one-year pooled outcomes for the DurAVR® Transcatheter Heart Valve (THV) in patients with small aortic annuli (mean annulus area 396 ± 37 mm2).
Key results: EOA 2.1 ± 0.2 cm2, mean pressure gradient 8.6 ± 2.6 mmHg, no valve-related mortality and no moderate or severe paravalvular leak at one year; 30-day prosthesis-patient mismatch was 1.5% versus 11.2%–35.3% for current devices. The pooled cohort included 65 small-annulus patients from EMBARK and a US early feasibility study; >100 patients have been implanted overall. Results will be evaluated further in the randomized PARADIGM pivotal trial (NCT07194265).
Anteris (NASDAQ: AVR) ha riportato esiti aggregati a un anno per la DurAVR® Transcatheter Heart Valve (THV) in pazienti con piccoli anelli aortici (area annulus media 396 ± 37 mm²).
Risultati chiave: EOA 2.1 ± 0.2 cm², gradienti medi di pressione 8.6 ± 2.6 mmHg, nessuna mortalità legata alla valvola e nessuna perdita paravalvolare moderata o severa a un anno; la disfunzione protesi-paziente a 30 giorni era 1.5% contro 11.2%–35.3% per i dispositivi attuali. Il cohorte aggregata comprendeva 65 pazienti con piccolo anello provenienti da EMBARK e da uno studio di fattibilità precoce statunitense; oltre 100 pazienti sono stati impiantati complessivamente. I risultati saranno ulteriormente valutati nel trial cruciale randomizzato PARADIGM (NCT07194265).
Anteris (NASDAQ : AVR) informó resultados agrupados a un año para la DurAVR® Transcatheter Heart Valve (THV) en pacientes con anillos aórticos pequeños (área media del anillo 396 ± 37 mm²).
Resultados clave: EOA 2.1 ± 0.2 cm², gradiente de presión medio 8.6 ± 2.6 mmHg, sin mortalidad relacionada con la válvula y sin fuga paravalvular moderada o severa a un año; la desproporción protésico-paciente a 30 días fue 1.5% frente al 11.2%–35.3% de los dispositivos actuales. La cohorte agrupada incluyó 65 pacientes con anillo pequeño de EMBARK y un estudio de viabilidad temprana en EE. UU.; se han implantado más de 100 pacientes en total. Los resultados serán evaluados más a fondo en el ensayo pivotal aleatorizado PARADIGM (NCT07194265).
Anteris (NASDAQ: AVR) 은 작은 대동맥 폐쇄부(평균 폐쇄면적 396 ± 37 mm²) 를 가진 환자에서 DurAVR® Transcatheter Heart Valve (THV) 의 1년 누적 결과를 보고했습니다.
주요 결과: EOA 2.1 ± 0.2 cm², 평균 압력 구배 8.6 ± 2.6 mmHg, 밸브 관련 사망 없음 및 1년 간 중등도 또는 중증 paravalvular leak 없음 ; 30일 프로스테시-환자 불일치(mismatch) 는 1.5% 로 현재 기기들에서의 11.2%-35.3% 와 비교된다. 누적 코호트에는 EMBARK 의 65명의 소형 관류 환자 와 미국 초기 타당성 연구가 포함됩니다; 전반적으로 100명 이상이 이식되었습니다. 결과는 무작위 PARADIGM 결정적 시험(NCT07194265)에서 더 평가될 예정입니다.
Anteris (NASDAQ : AVR) a rapporté les résultats groupés sur un an pour la DurAVR® Transcatheter Heart Valve (THV) chez des patients présentant de petits anneaux aortiques (surface annulaire moyenne 396 ± 37 mm²).
Résultats clés : EAO 2.1 ± 0.2 cm², gradient de pression moyen 8.6 ± 2.6 mmHg, aucune mortalité liée à la valve et aucune fuite paravalvulaire modérée ou sévère à un an ; le mismatch prothèse-patient à 30 jours était 1.5% contre 11.2%–35.3% pour les dispositifs actuels. La cohorte regroupée comprenait 65 patients à petit anneau issus d’EMBARK et d’une étude de faisabilité précoce américaine ; plus de 100 patients ont été implantés au total. Les résultats seront évalués plus en détail dans l’essai pivot randomisé PARADIGM (NCT07194265).
Anteris (NASDAQ: AVR) berichtete einjährige gepoolte Ergebnisse für das DurAVR® Transcatheter Heart Valve (THV) bei Patienten mit kleinen Aortenannuli (mittlere Annulusfläche 396 ± 37 mm²).
Schlüsselergebnisse: EOA 2.1 ± 0.2 cm², mittlerer Druckgradient 8.6 ± 2.6 mmHg, keine valve-bezogene Mortalität und kein moderater oder schwerer paravalvulärer Leck nach einem Jahr; die 30-Tage-Prothesen-Pazienten-Mismatch betrug 1.5% gegenüber 11.2%–35.3% bei aktuellen Geräten. Die gepoolte Kohorte umfasste 65 Patienten mit kleinem Annulus aus EMBARK und einer US-amerikanischen frühen Machbarkeitsstudie; insgesamt wurden über 100 Patienten implantiert. Die Ergebnisse werden weiter im randomisierten PARADIGM-Zentralstudie bewertet (NCT07194265).
Anteris (NASDAQ: AVR) أبلغت عن نتائج مجمّعة لمدة عام واحد لجهاز DurAVR® Transcatheter Heart Valve (THV) لدى مرضى لديهم حلقة ابهرية صغيرة (متوسط مساحة الحلقة 396 ± 37 مم²).
النتائج الرئيسية: EOA 2.1 ± 0.2 سم²، انحدار الضغط المتوسط 8.6 ± 2.6 مم زئبق، لا وفيات مرتبطة بالصمام و لا تسريب حول صمامي متوسط أو شديد خلال عام؛ كان تشوه المطابقة بين الجهاز والمريض عند 30 يوماً 1.5% مقابل 11.2%-35.3% للأجهزة الحالية. شملت العينة المجمّعة 65 مريضاً بآنحلقة صغيرة من EMBARK ودراسة جدوى مبكرة في الولايات المتحدة؛ تم زرع أكثر من 100 مريض بشكل عام. ستجرى تقييم النتائج بمزيد من التدقيق في تجربة PARADIGM المحورية العشوائية (NCT07194265).
Anteris (NASDAQ: AVR) 报告了 DurAVR® 经导管心脏瓣膜（THV）在小型主动脉窦患者中的一年汇总结果（平均窦面积 396 ± 37 mm²）。
关键结果：EOA 2.1 ± 0.2 cm²、平均压差 8.6 ± 2.6 mmHg、无瓣膜相关死亡以及 无中度或重度旁瓣漏，一年时；30天义肢患者错配率为 1.5%，而当前器械为 11.2%–35.3%。汇总队列包括 65 例小环患者来自 EMBARK 与美国早期可行性研究；总体植入患者超过 100 例。结果将在随机的 PARADIGM 关键试验（NCT07194265）中进一步评估。
- EOA 2.1 cm2 at one year
- Mean gradient 8.6 mmHg sustained to one year
- No valve-related mortality at one year
- No moderate/severe PVL at one year
- PPM 1.5% at 30 days versus 11.2%–35.3% for comparators
- Pooled small-annulus cohort size of 65 patients limits generalizability
- Findings are interim from ongoing studies and require confirmation in the PARADIGM RCT
Insights
DurAVR shows favorable one-year hemodynamics in small annuli with no valve-related deaths and low PPM.
The pooled cohort of 65 small-annulus patients recorded an effective orifice area of 2.1 ± 0.2 cm2 and mean pressure gradient of 8.6 ± 2.6 mmHg at one year, with no moderate or severe paravalvular leak and no valve-related mortality. These measures directly describe valve performance: larger EOA and lower mean gradients indicate lower obstruction to flow, and the absence of moderate/severe PVL reduces a known source of morbidity.
Key dependencies and risks include the small pooled sample (65 patients) and that results derive from combined early studies (EMBARK and US EFS) rather than the randomized PARADIGM trial. The 30-day prosthesis-patient mismatch rate of
Watch for the randomized global PARADIGM Trial (ClinicalTrials.gov ID NCT07194265) for confirmatory safety and effectiveness data and for prespecified endpoints, enrollment size, and longer-term follow-up beyond one year. Near-term items to monitor: published full cohort baseline characteristics, independent core-lab hemodynamic adjudication, and PARADIGM primary endpoint readouts in the trial's planned follow-up windows.
MINNEAPOLIS and BRISBANE, Australia, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced one-year clinical outcomes for the DurAVR® Transcatheter Heart Valve (THV) in symptomatic severe aortic stenosis patients with small aortic annuli (aortic annulus area 396 + 37 mm2). The DurAVR® THV System demonstrated single digit mean gradients and large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality at one year, with low prosthesis-patient mismatch at 30 days.
One-year Results Highlights
- DurAVR® THV delivered a favorable hemodynamic profile sustained to one-year, with an EOA of 2.1 + 0.2 cm2 and a mean pressure gradient (MPG) of 8.6 + 2.6 mmHg.
- At one-year, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalvular leak (PVL).
- At 30-days, prosthesis-patient mismatch* was just
1.5% , compared with11.2% to35.3% 1 for current commercial devices, highlighting a meaningful reduction in a key predictor of valve failure and disease progression.
“With small annuli patients, even minor hemodynamic inefficiencies can limit long-term outcomes, which is why optimising physiologic flow is so critical. The latest results we are seeing with the balloon-expandable DurAVR® valve are impressive, showing restoration of laminar flow, favorable hemodynamics sustained to one year, predictable deployment and a high level of procedural success across a variety of anatomies, which is exactly what we need for this patient population,” commented Dr. Rishi Puri, MD, PhD, Coronary and Structural Interventional Cardiologist at the Cleveland Clinic.
The pooled cohort included 65 patients with small aortic annuli implanted with the DurAVR® THV from the ongoing EMBARK Study and US Early Feasibility Study (EFS).
The encouraging clinical outcomes observed to date in over 100 patients implanted with the DurAVR® THV will be further validated in the Company’s recently initiated global pivotal trial (the “PARADIGM Trial”). The PARADIGM Trial (ClinicalTrials.gov ID NCT07194265) is a prospective, randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs) in the treatment of severe aortic stenosis.
*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)².
1. Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchétché D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7. PMID: 38587261.
2. Ferrara J, Theron A, Porto A, Morera P, Luporsi P, Jaussaud N, Gariboldi V, Collart F, Cuisset T, Deharo P. Prosthesis-Patient Mismatch in Small Aortic Annuli: Self-Expandable vs. Balloon-Expandable Transcatheter Aortic Valve Replacement. J Clin Med. 2022 Apr 1;11(7):1959. doi: 10.3390/jcm11071959. PMID: 35407567; PMCID: PMC8999619.
About Anteris
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.
Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System.
Forward-Looking Statements
This announcement contains forward-looking statements, including statements regarding the further validation of results in the PARADIGM Trial. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.
| For more information: | ||
| Investor Relations investor@anteristech.com Debbie Ormsby Anteris Technologies Global Corp. +61 1300 550 310 | +61 7 3152 3200 | Investor Relations (US) mchatterjee@bplifescience.com Malini Chatterjee, Ph.D. Blueprint Life Science Group +1 917 330 4269 | |
| Website | www.anteristech.com | |
| X | @AnterisTech | |
| LinkedIn | https://www.linkedin.com/company/anteristech | |
FAQ
What were the one-year hemodynamic results for Anteris DurAVR (AVR) in small annuli?
Did Anteris report any valve-related deaths for DurAVR at one year (AVR)?
How common was prosthesis-patient mismatch (PPM) after DurAVR (AVR) implantation?
How many small-annulus patients were included in the DurAVR one-year pooled analysis?
Will the DurAVR one-year results be validated in a randomized trial?
