Close

Search

Search Menu
Photonics Media Photonics Buyers' Guide Photonics EDU Photonics Spectra BioPhotonics EuroPhotonics Industrial Photonics Photonics Showcase Photonics ProdSpec Photonics Handbook
More News
SPECIAL ANNOUNCEMENT
2016 Photonics Buyers' Guide Clearance! – Use Coupon Code FC16 to save 60%!
share
Email Facebook Twitter Google+ LinkedIn Comments

Spectranetics Meets Enrollment Target for LACI Phase 2 Study

Photonics.com
Apr 2002
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.



Comments
Terms & Conditions Privacy Policy About Us Contact Us
back to top

Facebook Twitter Instagram LinkedIn YouTube RSS
©2016 Photonics Media
x We deliver – right to your inbox. Subscribe FREE to our newsletters.