27 March 2020
FIRST PATIENT IN SAVR TRIAL SUCCESSFULLY IMPLANTED
Admedus Limited (ASX:AHZ) (Admedus or the company) announces the first implantation of its ADAPT® treated single-piece 3D aortic valve in a patient with aortic stenosis.
Professor Bart Meuris MD, PhD, Chief of Cardiovascular Surgery at the University Hospitals, Leuven, Belgium, conducted the cardiac heart valve surgery. Fifteen patients will be enrolled in the first-in-human study and followed up for 6 months after receiving implantation of the ADAPT® single-piece 3D aortic valve. Results from the study are expected between Q1, 2021 and Q3, 2021.
The Admedus single-piece 3D aortic valve combines an innovative design with the scientifically proven APAPT® tissue technology. With 10 years of clinical data showing no calcification in patients using ADAPT® tissue, the superior durability of the Admedus valve could revolutionise the valve repair and replacement markets.
“This is a huge milestone for Admedus. The data collected on these patients will give us insights to the valve function in the near term proving highly valuable to our TAVR program. The preliminary post-operative data initially collected were highly encouraging.”
“The trial’s objective is to demonstrate implantation safely. It will also provide useful insights into the tissue science and valve design. This will help us confirm the clinical benefits relating to haemodynamic function and durability, while further building on our strong body of data we have,” Admedus Chief Executive Officer, Mr Wayne Paterson, said.
More information on the clinical trial is available here:
Read the full announcement here