Close

Search

Search Menu
Photonics Media Photonics Buyers' Guide Photonics Spectra BioPhotonics EuroPhotonics Vision Spectra Photonics Showcase Photonics ProdSpec Photonics Handbook
More News

Spectranetics Meets Enrollment Target for LACI Phase 2 Study

Facebook Twitter LinkedIn Email Comments
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.


Photonics.com
Apr 2002
News & Features

Comments
back to top
Facebook Twitter Instagram LinkedIn YouTube RSS
©2020 Photonics Media, 100 West St., Pittsfield, MA, 01201 USA, [email protected]

Photonics Media, Laurin Publishing
x We deliver – right to your inbox. Subscribe FREE to our newsletters.
We use cookies to improve user experience and analyze our website traffic as stated in our Privacy Policy. By using this website, you agree to the use of cookies unless you have disabled them.