Spectranetics Reports on 12-Month CELLO Data

Freedom from Re-Intervention Achieved in 78% of Patients 12 Months Post-Procedure

COLORADO SPRINGS, Colo.--(HSMN NewsFeed)--Spectranetics (NASDAQ:SPNC ) announced the 12-month follow-up data from the CELLO study at the Leipzig Interventional Course (LINC) meeting held last week in Leipzig, Germany. The data was presented by Dr. Rajesh Dave, principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital in Harrisburg, Pennsylvania.

The CELLO study is a prospective, multi-center registry which enrolled 65 patients treated with directed laser ablation of lesions of the superficial femoral arteries and popliteal arteries using the TURBO-Booster device. The primary endpoint of the study, which has been previously reported, was the percentage reduction in the stenosis prior to adjunctive therapy. Prior to treatment, the mean stenosis, or blockage, as measured by an independent core lab, was 77%. The mean stenosis following use of the TURBO-Booster was 42% and 21% after adjunctive therapy, which was either balloon angioplasty or balloon angioplasty and stenting. Stenting was performed in only 23% of the procedures. Of these patients, 86% and 78% were free from a repeat intervention at six and 12 months post-procedure, respectively. Patency as measured by duplex ultrasound was 59% and 54% at six and 12 months post-procedure, respectively. The primary safety endpoint was major adverse cardiac events at six months. No major adverse cardiac events occurred at six months. Measures of functional improvement included change in Rutherford class, walking impairment and ankle-brachial index, which all showed improvement at six months compared to baseline. Improvement was maintained in all three of these functional measures through the 12 month follow-up. All data from the CELLO trial has been submitted by Spectranetics to the Food and Drug Administration, which has accepted the data as part of the process to conclude the study.

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