The current shelf-life of Boston Scientific Corporation (NYSE: BSX)’s TAXUS® Express (2)™ paclitaxel-eluting coronary stent system in the United States is 12 months.
The USFDA has just granted the approval to extend that shelf-life to 18 months based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the TAXUS Stent (particularly the drug content, drug degradation profile and drug-release) was maintained within FDA-approved specifications at 18 months.
According to Hank Kucheman, Senior Vice President and Group President of Boston Scientific's Interventional Cardiology Group:
"We are very pleased the FDA has approved an extended shelf life for the TAXUS Express(2) Stent, which may help facilitate inventory management for hospitals concerned with product expiration of drug-eluting stents. The 18-month shelf life for the TAXUS Stent is three times longer than the Cypher Stent, which has FDA approval for a six- month shelf life."
The extended expiration date applies to all available sizes of the TAXUS Stent for sale in the United States.
Source: Boston Scientific Corporation
[Photo Credit: USFDA]
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