Spectranetics
This article was originally published in The Gray Sheet
Executive Summary
Laser maker anticipates third or fourth quarter FDA clearance to proceed with Phase II of its Laser Angioplasty for Critical Ischemia (LACI) trail examining excimer laser technology to treat limb-threatening vascular blockages below the knee. Phase I, for which enrollment is now complete, involved four U.S. centers and 25 patients. Spectranetics expects to enroll a few hundred patients all together, but is discussing specifics with FDA