The PQT-5000 is the first pulsatile flow heart valve functional performance test system designed specifically for the production environment within a cleanroom. This highly advanced pulse duplicator system integrates key attributes such as rapid valve exchange for high throughput, multiple cameras to document leaflet kinematics and 21 CFR Part 11 compliant software that integrates both hydrodynamic waveform data and high-speed video. The heart valve is assessed against a battery of user-defined QA performance metrics, providing a clear pass-fail result for each valve in a rapid, reliable and highly consistent manner.
The PQT-5000 assesses the functional heart valve performance and leaflet kinematics through a range of parameters such as:
The PQT-5000 production pulse duplicator is an integrated test apparatus that includes atrial and ventricular chambers, a compliance chamber, peripheral resistance and a valve rapid-exchange mechanism and is driven by BDC Labs PD-1100 Pulsatile Pump. The test system interface is achieved through BDC’s Statys® PQT software. Following a detailed consultation with each client, BDC can customize our heart valve production test system for any specific heart valve production test requirements.