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FDA approves Boston Scientific PROMUS 2.25 mm coronary stent

The US Food and Drug Administration (FDA) has approved Boston Scientific’s 2.25 mm PROMUS Everolimus-Eluting Coronary Stent System for use in vessels as small as 2.25 mm in diameter.

The stent, which features a thin-strut and open-cell design with catheter tip, helps enhance deliverability, especially in small vessels.

The PROMUS Stent is supported by the SPIRIT clinical trial program, which demonstrated controlled release of everolimus results in low levels of late loss and a strong safety profile.

The addition of the stent expands the available size matrix of Boston Scientific‘s PROMUS Stent portfolio to include diameters from 2.25 to 4.0 mm and lengths from 8 mm to 28 mm for the treatment of small vessels and long lesions.

The PROMUS Stent is manufactured by Abbott and distributed by Boston Scientific.

The company plans to immediately launch the product in the US.