COLORADO SPRINGS, Colo., April 15 -- The Spectranetics Corp. has reached the enrollment target of 137 registry patients in its LACI (laser angioplasty for critical limb ischemia) Phase 2 study, which tests use of the excimer laser to improve circulation to the lower leg. The company said it will continue enrolling patients in LACI Phase 2 in order to include its Extreme II peripheral excimer laser catheters, which were recently FDA-approved for the LACI study.
Spectranetics said it plans to conclude enrollment in LACI Phase 2 no later than April 30, when LACI will enter a six-month follow-up period to monitor the progress of enrolled patients. After the follow-up, Spectranetics said it expects to submit to the FDA for pre-market approval in early 2003, which could lead to an approval in the second half of 2003. In the meantime, Spectranetics has requested FDA permission to begin LACI Phase 3, a continuation of the LACI registry for 300 additional patients at 20 sites.