BRISBANE, Australia & MINNEAPOLIS--(BUSINESS WIRE)--Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR, OTC: ANTTY) reported today that DurAVR™ Transcatheter Heart Valve (THV), a new class of biomimetic valve and the world’s only biomimetic, single-piece transcatheter aortic valve, was used to successfully to treat patients as part of the DurAVR™ THV Early Feasibility Study (EFS or the Study) in the United States. The EFS is an essential step towards receiving FDA approval in the US and commercialization of this innovative medical technology.
Dr. Azeem Latib, Director of Interventional Cardiology, Director of Structural Heart Interventions at Montefiore Health System, New York, and Study National Principal Investigator (IC), performed the first group of US DurAVR™ THV procedures.
The first group of severe aortic stenosis patients treated with DurAVR™ THV had intraoperatively, post-implant EOAs of 2.2cm2, and average mean gradients of 4mmHg.
Dr. Latib commented:
“Having previously traveled to Europe with Anteris to implant patients with DurAVR™ THV, I am delighted to note that the post-procedure patient outcomes seen in US patients at my center corroborate with data reported from previous cohorts. The ability to use this device with such excellent hemodynamic results, as well as ease of use, is incredible progress in the treatment of patients with severe aortic stenosis. We look forward to many more cases in the near future.”
The EFS Study is evaluating the safety and feasibility of DurAVR™ THV in the treatment of subjects with symptomatic severe native aortic stenosis (AS). Enrolling ≥15 subjects at 7 Heart Valve Centers of Excellence within the United States. Dr. Mike Reardon, Chair of Cardiovascular Research at the Houston Methodist DeBakey Hospital, is the Study Chair. This is an FDA-designated category B study and approved by CMS for reimbursement.
The primary endpoint of this Study at 30 days post-implantation will assess safety and device feasibility. This US EFS Study data will pave the way for a pivotal registrational trial.
Wayne Paterson, CEO of Anteris Technologies, commented:
“The successful treatment of these patients in the United States is yet another important milestone on our path to commercialization of the DurAVR™ TAVR system. The patients enrolled at Montefiore Hospital in New York this week add to our body of evidence that supports the use case of DurAVR™ THV and its clinical superiority and validates the reproducibility of our data and the stellar performance to date. Today’s patients had excellent outcomes with intraoperative mean gradients of 4mmHg. This further supports the case that DurAVR™ is both clinically viable and will be an important product for the treatment of aortic stenosis in the future, giving patients and physicians alternatives to current therapies.”
Dr. Chris Meduri, CMO of Anteris Technologies, added:
“We are pleased with the excellent results achieved by Dr. Latib and the team at Montefiore. We look forward to sharing the results at TCT 2023.”
About Anteris Technologies Ltd (ASX: AVR)
Anteris Technologies Ltd (ASX: AVR) is a structural heart company committed to designing, developing, and commercializing innovative medical devices. Founded in Australia, with a significant presence in Minneapolis, USA, a MedTech hub, Anteris is science-driven, with an experienced team of multidisciplinary professionals delivering transformative solutions to structural heart disease patients.
The Company’s lead product, DurAVR™, is a transcatheter heart valve (THV) for the treatment of aortic stenosis. DurAVR™ THV has been designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons and is the first transcatheter aortic valve replacement (TAVR) to use a single piece of bioengineered tissue. This biomimetic valve is uniquely shaped to mimic the performance of a healthy human aortic valve.
DurAVR™ is made using ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue has been used clinically for over 10 years and distributed for use in over 50,000 patients worldwide.
Controlled deployment and accurate placement of DurAVR™ THV is via Anteris’ proprietary ComASUR™ Delivery System. This system allows precision alignment with the heart’s native commissures to achieve optimal valve positioning.
Anteris Technologies is set to revolutionize the structural heart market by delivering clinically superior solutions that meet significant unmet clinical needs.
Authorization and Additional Information
This announcement was authorized by the Board of Directors.