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A new Cobalt Chromium alloy with a proven track record as a vascular implant material has been selected for the ChromoFlex stent. This material is not only stronger and more corrosion resistant than the traditional "goldstandard" of 316LVM Stainless Steel, but also offers significantly improved radiopacity. The material is manufactured to the highest standards and has proven clinical safety as an implantable material.
Recently the ISAR STEREO I and II studies conclusively demonstrated the benefits of thin struts for reducing restenosis. In-line with DISA Vascular's ongoing low-injury stent design philosophy for the minimisation of restenosis, the company has developed the Chromoflex stent with up to 35% reduction in stent strut thickness on the already relatively thin struts of the proven S-Flex stainless steel product. Enhanced scaffolding together with the stronger material properties and enhanced visibility of the Cobalt Chromium alloy make this improvement possible without compromising on radial strength or stent visibility.
The S-Flex stent has independently been proven to show superior flexibility and mounted profile characteristics compared to many of its competitors (see results of New Zealand Study). Now with the new ChromoFlex, these characteristics have been even further enhanced. Stent Flexibility has been improved by up to 20% and profile reduced by 10%. These optimised features make the ChromoFlex especially suitable in the emerging era of drug delivery where more and more tortuous, difficult to access lesions will be targeted.
The stent design philosophy of DISA Vascular has always placed a strong emphasis on reducing vessel-wall injury and maximising scaffolding support - as seen in the proven 8-cell S-Flex stent. A number of studies in the literature have supported this rationale. Now with the superior properties of Cobalt Chromium, the ChromoFlex offers even greater scaffolding support (25% more circumferential struts than the stainless steel S-Flex).
The higher molecular density of the Cobalt Chromium Alloy makes this material far more radiopaque than Stainless Steel. The inclusion of highly radiopaque Tungsten allows the significant reductions in strut dimensions while still maintaining good visibility under fluoroscopy.
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