AST’s blossoming stent trial
This article was originally published in The Gray Sheet
Executive Summary
Advanced Stent Technologies expects to receive FDA approval to begin enrollment "in the next several months" of up to 100 patients at four to six U.S. sites to study its Petal coronary bifurcation bare-metal stent. The firm received conditional approval for use of Petal and its delivery system in 30 nonrandomized patients in its U.S. BOSS study on Sept. 3. FDA had cleared an investigational device exemption for Petal in December 2001 for a 30-patient feasibility study (1"The Gray Sheet" Sept. 3, 2004, p. 27). AST gained a CE mark for a rapid-exchange version of its SLK-View DSX stent for treating bifurcated lesions in February 2003...