Admedus (AHZ) has implanted the first patient who has aortic stenosis with its ADAPT 3D aortic valve.
In mid-January; the company received approval to begin the first in-human trial. The aim of this study is to collect data on ADAPT's safety and performance.
- Admedus (AHZ) has implanted the first patient who has aortic stenosis with its ADAPT 3D aortic valve
- Aortic stenosis is the narrowing of the aortic valve and the restriction of blood flow in the body
- A total of 15 patients will be enrolled in the first in-human study and will be followed up for six months
- Results from this study are expected between quarter one and quarter three in 2021
- Admedus' ADAPT valve closely mimics the characteristics and functions of normal human tissues
- This causes a better immune response and improved tissue growth
- Admedus is up 19.6 per cent on the market today and trading for $4.46 each
According to the American Heart Association, aortic stenosis is one of the most common and serious valve disease problems.
This condition is the narrowing of the aortic valve opening and the restriction of blood flow from the left ventricle of the heart to the aorta (the main artery that carries blood from the heart to the rest of the body).
Those with aortic stenosis often experience chest pains, fainting, heart murmurs, or difficulty breathing.
Mild cases will often not need treatment and may only need rest, however, most serious cases often need a valve repair or valve replacement to return the heart function back to normal.
This surgery was conducted by Professor Bart Meuris MD, PhD, Chief of Cardiovascular Surgery at the University Hospitals, Leuven, Belgium.
A total of 15 patients will be enrolled in the first in-human study and will be followed up for six months after receiving the ADAPT valve.
Results from the study are expected between Q1 2021 and Q3 2021.
ADAPT is a single 3D aortic valve that is the correct size of a human valve.
Tissue treated with Admedus' ADAPT technology has been scientifically proven to closely mimic the characteristics and functions of normal human tissue.
This prompts a more tolerant immune response and improved tissue growth."
"This is a huge milestone for Admedus. The data collected on these patents will give us insights to the valve function in the near term proving highly valuable to our TAVR transcatheter aortic valve replacement program," CEO Wayne Paterson said.
"This trial will help us confirm the clinical benefits relating to haemodynamic (good flow) function and durability, while further building on our strong body of data we have," he added,
Admedus is up 19.6 per cent on the market today and shares are trading for $4.46 each.
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