"IGAKI-TAMAI® STENT", the bioabsorbable stent for peripheral artery which obtained CE-marking on 2007-11-29 was improved and its registration for CE-marking was modified.
Bioabsorbable stent (Biodegradable stent)
“IGAKI-TAMAI® STENT” Bioabsorbable stent is formed of biodegradable polymer PLLA (poly-L-lactic acid). The stent has the characteristics of being dissolved into water and carbon dioxide and absorbed into vessel tissue within a few years after implantation. It is possible to use also for patients who could not receive a stent due to with metal allergies or being still growing. Even though a stented segment becomes narrow again, the implanted PLLA stent which does not remain in the body permanently will not interfere with other procedures such as restenting, Stent is implanted by expanding balloon. Formerly, thermal temperature contrast media had been used in expansion of balloon for implantation of PLLA stent. Currently, normal temperature contrast media is available for expanding balloon to implant the stent. Furthermore, PLLA stent is more useful for containing drugs compared to metal stents, and thus, it has been intended as a platform for drug eluting stents.
Left: IGAKI-TAMAI® STENT for coronary artery
Right: IGAKI-TAMAI® STENT for peripheral artery |
Left: Lesion (arrowed)
Right: Lesion after IGAKI-TAMAI® STENT for peripheral artery was implanted (arrowed) |
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**CE mark: Safety mark that is obligated to be affixed on the specific products placed on the market within the European Union (EU). The CE mark bearing on a product indicates that the product meets the ESRs (Essential Safety Requirements) of the EU (EC) directive. The CE mark appears on the product, the packaging and the package insert to indicate that the given conformity assessment has been carried out by a notified body in EU. The product bearing the CE mark is warranted its free marketing within the EU.
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