Boston edges closer to US DES (drug-eluting stent) sector:
This article was originally published in Clinica
Boston Scientific has taken an important step towards gaining US approval for its drug-eluting stent (DES). The firm has submitted to the FDA the first module of its premarket approval (PMA) application for its TAXUS paclitaxel-eluting coronary stent system. Boston says that it plans to submit the fifth and final module in June, which will include data from its large, pivotal TAXUS IV clinical trial. Rival firm Johnson & Johnson (J&J) is the only other firm to have submitted a PMA for a DES. Following a favourable FDA panel review for its product last year, J&J is awaiting a final decision from the agency (see Clinica No 1030, p 19).
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