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Spectranetics Gets FDA Approval for Final Phase of LACI Trial

Photonics.com
Feb 2001
COLORADO SPRINGS, Colo., Feb. 8 -- The Spectranetics Corp. has received approval from the US Food and Drug Administration to begin the second phase of its Laser Angioplasty for Critical Limb Ischemia (LACI) trial, which is intended to demonstrate the safety and effectiveness of laser angioplasty technology to treat blockages in arteries of the leg, primarily at or below the knee. The company will begin the phase 2 trial immediately and enrollment is expected to take 12-15 months to complete.
We're excited to begin Phase 2 of the LACI trial because results from Phase 1 were so promising, said John R. Laird, the LACI principal investigator at Washington Hospital Center in Washington, D.C. Although our primary endpoint for Phase 1 was wound healing at three months, the compelling observation when reviewing the data was that the vast majority of the patients in the study still had their limbs six months later. Without laser angioplasty, we would have expected significantly more major amputations among the group. The LACI investigators believe laser angioplasty will bring new hope to patients who have very few options left.


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