Transcatheter and surgical heart valve repairs and replacement devices need to be tested very often. During the testing procedure, the expert team will check the device and valve for accuracy and durability. The testing has to be done under different conditions and speeds.
- An expert team is responsible for conducting the testing procedure for valves and devices
- At the end of the testing procedure, the product is rated safe to use
- The valve and devices are also tested for biocompatibility
Experts will ensure each valve and device undergoes strict heart valve testing – AWT, durability, hydrodynamic procedures.
Why the need for testing heart valves?
There may be many conditions, abnormalities, diseases, and infections when repair or replacement is the only options left. The aortic valve might malfunction at any time. Heart valve replacement is the only solution left.
To ensure the valve and devices are functioning normally under various conditions; the testing has to be conducted. This is important for the patient during replacement and repair tasks.
Testing for durability
Once the heart valve has been replaced or repaired, it has to be tested for durability. The heart will keep pumping for your lifetime. Thus the valve has to be functioning till the heart is pumping. Malfunction can lead to severe conditions for the patient including death.
If the valve that is replaced is not tested for durability, then the chances of malfunction will increase. This is why the valve is tested for durability so it is long-lasting.
Valve frame testing
Each valve that has to be replaced has to fit inside the frame. The frame offers the valve with right pressure support. Till the valve is functional, the frame will offer the best support. The frame is a small device that is cut into an exact shape using laser cutting technology.
The frame has to be made up of bioabsorbable polymer material. A mock vessel that replicates the exact heart condition is used for conducting the testing procedure. The testing helps fatigue and strain testing. Bovine Pericardium Tissue testing is also used to check the compatibility of the valve.
The entire process of testing is to be done on the valve before it is replaced or placed inside the human body. If the valve malfunctions, it is easy to correct it before the valve is placed inside the heart cage.
Acceptance and failure of the device
In few cases, the valve and tissue may fail the testing. There may be many different reasons for the device’s failure. The moment failure happens it is easy to correct it outside the body. The process of making changes is easy to conduct outside the human body.
You need to keep in mind that failures and acceptances happen. Making changes is possible in most cases. If it happens outside the body then the loss is limited.