Anteris Technologies has reported that its DurAVR biomimetic, single-piece transcatheter aortic valve, has been successfully used to treat patients as part of the DurAVR THV Early Feasibility Study (EFS) in the USA.
Azeem Latib (Montefiore Health System, New York, USA) the national principal investigator of the study performed the first group of US DurAVR procedures. Among these patients with severe aortic stenosis treated with the DurAVR transcatheter heart valve (THV), the implant resulted in intraoperative, post-implant effective orifice areas (EOAs) of 2.2cm2, and average mean gradients of 4mmHg.
Latib commented: “Having previously travelled 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 centre corroborate with data reported from previous cohorts. The ability to use this device with such excellent haemodynamic 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 seven heart Vvalve centers of excellence within the USA, Michael Reardon (Houston Methodist DeBakey Hospital, Houston, USA) is the study chair. The study is an FDA-designated category B study and approved by Centers for Medicare & Medicaid Services (CMS) for reimbursement.
The primary endpoint of the 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 USA is yet another important milestone on our path to commercialisation of the DurAVR TAVI [transcatheter aortic valve implantation] 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.”
Further to its announcement on the clinical study progress, Anteris has also reported that it has established a sponsored Level 1 American Depository Receipt (ADR) program in the USA. The ADR program has been set up to improve U.S. investor access to Anteris ordinary shares. ADRs are a financial instrument that allow US investors to hold shares of a foreign company without the need for cross-border or cross-currency transactions.
“Establishing an ADR program through a partnership with Deutsche Bank will increase the company’s visibility and recognition among US investors, analysts, and financial media,” said Paterson. “This exposure will raise awareness about the company and our leading DurAVR technology with key stakeholders in the world’s largest capital market.”