Five TAVR Patients Successfully Implanted with DurAVR Valve
Anteris reports successfully implanting five TAVR patients during the week of 14 November 2021 in a first-in-human (FIH) study to assess the DurAVR™ THV system for treating severe aortic stenosis. The study was carried out at the Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia.
The transcatheter aortic valve replacement procedures for all five patients were successful and without any complications. An additional five patients are planned for treatment in the first quarter of 2022 to conclude the study.
Anteris’s Chief Medical Officer, Dr Chris Meduri, and Medical Advisory Board members, Dr Paul Sorajja and Dr Vinayak Bapat, did the procedures whilst Dr Nadira Hamid (Columbia University, New York) performed the echocardiograms. Medical support was provided by the local team under the supervision of Dr Tamaz Shaburishvili.
The study was designed to assess the following performance endpoints:
• Correct positioning of the DurAVR™ valve at the proper anatomical location; and
• Haemodynamic performance.
As well as safety endpoints (30 days and 1 year):
• All-cause mortality
• Myocardial infarction
• Life threatening bleeding.
Other endpoints include DurAVR™ THV system ease of use (commissural alignment) and adverse events (according to VARC-3 criteria).
“In this early experience, DurAVR™ showed superior haemodynamics with some of the largest EOAs (effective orifice areas) I have seen in any TAVR platform. Remarkably, this was observed with rapid deployment techniques and standard implant depths and in small aortic annular areas. Importantly, there were no adverse events. This technology allows us to provide superior haemodynamics with a balloon expandable platform,” Dr Paul Sorajja said.
“The meticulous preparation for this study has led to an outstanding set of results and patient outcomes. Not only did the valve performance exceed our very high expectations but the additional aspects of commissural alignment, flow characteristics and haemodynamics were proven to be clinically significant. We are excited to now add more patients to our studies in 2022,” Anteris CMO, Dr Chris Meduri, added.
“These first 5 patients go a long way in proving the unique benefits of the DurAVR™ valve and validating the prior preclinical work and the results so far are better than anticipated. We are grateful for the patients who consented to being a part of the study as well as the physicians who performed the implants. The Anteris team have done a phenomenal job to date to move this technology into the clinical setting in such a short timeframe.” CEO Wayne Paterson concluded.
About Anteris Technologies Ltd (ASX: AVR) Anteris Technologies Ltd is a structural heart company delivering clinically superior and durable solutions through better science and better design. Its focus is on developing next generation technologies that help healthcare professionals create life-changing outcomes for patients.
The Anteris DurAVR™ aortic replacement valve addresses the acute need in terms of superior hemodynamic profile as well as chronic needs in its ability to sustain that profile longer over the lifetime of the patient.
The proven benefits of its ADAPT® tissue technology, paired with DurAVR™’s unique 3D single-piece aortic valve design, has the potential to deliver a functional cure to aortic stenosis patients and provide a much-needed solution to the challenges facing heart surgeons today.
Authorisation and Additional information
This announcement was authorised by Mr Wayne Paterson, Chief Executive Officer.
For more information:
Hannah Howlett WE Communications E: WE-AU AnterisTech@we-worldwide.com P: +61 4 5064 8064 www.anteristech.com Twitter: @AnterisTech Facebook: www.facebook.com/AnterisTech