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Medinol’s 2-dimensional quality control phase in unique in several respects:
- it is performed very early in the manufacturing process
- it inspects both side of the flat panel
- it allows the use of automated visual inspection
- it is a comprehensive process, covering 100% of each stents surface
It is the multi-dimensional nature that allows us to perform such a robust quality control phase so early on in the manufacturing process. This phase takes place before the stents take on their final tubular shape, at a phase where limited resources have been invested in them. Thus, we are able to adopt the highest quality standards offered by inspection technology.
The ability to access both sides of the lattice means we are able to inspect both the inner and outer sides of the stent. The integrity of the stent is affected by defects on both the outer and inner surface of the stent. However, it is primarily defects on the inner surface that could compromise compatibility with blood flow and might lead to thrombogenicity or delayed healing. It is exactly that inner surface that is hard or impossible to inspect in stents formed from a tube.
The similarity between our manufacturing process and that used in the integrated circuits industry also allows us to use process control techniques similar to the ones used in that high-precision industry. Thus, in addition to manual inspection, which is very common in our industry, we are able to apply a unique Automated Visual Inspection (AVI) procedure that have been developed by our engineers and perfected over the last 16 years. In the AVI procedure a computer compares each and every section of the flat panel with the respective section in the original design.
In addition to the unparalleled degree of accuracy achieved by using the AVI procedure, it is also a comprehensive process that automatically and systematically covers the entire surface of the panel and all the stent lattices of which it is comprised.
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