Dynatek demonstrates first commercial stent tester
drug-eluting stent tester to audiences throughout the US and
Europe, signifying the first time a coating durability tester for
medical devices has been commercially available.
The development of the coating durability tester (CDT) responds to a belief within the industry that developers of drug-eluting and coated devices will soon be required to test the shedding of drug particles as part of their evaluation of their product's durability.
Dynatek's CDT adds the benefit of real-time evaluation of device coating to the proven accelerated durability testing of the Small Vascular Prosthesis Tester (SVP) and Large Vascular Prosthesis Tester (LVP).
The CDT measures both size and number of particles as shedding occurs, without removal of the testing solution. This particle counting allows the user to know when stent shedding occurs, evaluating two elements of durability with one tester.
Applications for the CDT include device and coating durability testing for large vascular stents, small vascular stents, bifurcated stents, and other coated devices.
David Crump, general manager of Dynaltek dalta Scientific Instruments, told in-Pharmatechnologist.com: "Many of our clients develop their own in-house testers, but from the response the CDT has generated so far, it would seem that very few companies have been able to develop equivalent technology for themselves."
Dynatek's dalta's CDT features a pulsating testing environment to allow for expansion and contraction of the device similar to in vivo motion.
In addition, laser particle counting is possible to detect shed particles in real time and identify the size and number of shed particles. The user will know the precise point at which particles are shed.
A bypass filtration system allows for removal of the filters for particle analysis without interrupting the test.
Parameter modification capabilities also let the user choose the size of particles to be detected, and group the particles by size range.
Stenting is growing in popularity as a means of keeping arteries narrowed by atherosclerotic plaques from closing completely, precipitating a heart attack or other major cardiovascular event. The device functions as a scaffold, supporting the walls of the affected artery and preventing closure.
Stents have revolutionised the treatment of coronary artery disease, with close to 100 per cent penetration in the US, and 50-60 per cent in the UK. The market for drug-eluting stents is expected to reach $5.5 billion (€4.6 billion) by the end of this year and $6.3 billion by 2007.
"The growing number of drug-eluting and coated devices, coupled with the standards being developed by the various regulatory bodies, such as AAMI and ISO, suggest that demand for testers that can evaluate shedding from these devices will increase in the near future," said Crump.
