Guidant resolves DES fracture problem:
This article was originally published in Clinica
Guidant says it has solved the fracture problem identified in its investigational drug-eluting stent (DES) earlier this year. In late May, the company said that "issues" had been identified relating to the stainless steel stent platform of its lead DES, an everolimus-coated stent called Champion. The issues occurred in a limited number of stents implanted in preclinical studies. The company says that it is now working on optimising its manufacturing processes and that it is on track to launch the device in Europe in mid-2005. An investigational device exemption for permission to begin a pivotal trial of the product in the US is expected to be submitted to the FDA in the first quarter of next year.
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