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Biocompatibles Hedging On Safety, Efficacy Goals For Drug-Coated Stents

This article was originally published in The Gray Sheet

Executive Summary

Biocompatibles is focusing on the safety of its dexamethasone-coated stent at the expense of efficacy in a bid to expedite regulatory approval, while stressing the reverse for its batimastat delivery program

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PMA supplement approval for small vessel over-the wire version of the coronary stent (SV OTW) comes six months after FDA sign-off on the first version of the phosphorylcholine (PC) coated stent - the AS OTW Added Support system. The small vessel version is approved for abrupt or threatened closure on 2.0 mm and 2.5 mm diameter OTW delivery catheters. The AS OTW system is for de novo native lesions with vessel diameters 3.0-4.0 mm. An August 2001 PMA supplement is pending for the OC OTW Optimized Conformability version. Separately, Biocompatibles notes it has submitted an IDE for the 40-center, pivotal U.S. BATMAN II trial of its batimastat MMP inhibitor-coated BiodivYsio stent with PC technology for delivery. The U.S. trial will build upon the Latin American BATMAN pilot and European BRILLIANT trials already underway (1"The Gray Sheet" Nov. 5, 2001, p. 23)...

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