FAQ

* Spectranetics conducted a multi-center, two-phased clinical trial using peripheral excimer laser angioplasty to treat critical limb ischemia patients who were poor surgical candidates. The clinical trial results were published in the Journal of Endovascular Therapy, a peer-reviewed medical journal. The objective of the study was to evaluate the effectiveness of excimer laser angioplasty in critical limb ischemia patients with complex blockages in their legs. The study population included only those patients who were determined to be poor or non-surgical candidates. As a result, these patients were at high risk for limb loss. The primary endpoint of the trial, limb salvage among surviving patients at six months following the initial laser treatment, was 93 percent.

** Safe, effective and efficient data referenced from FDA: Summary of Safety and Effectiveness Data – Spectranetics 12 French Laser Sheath Kit – PLEXES: P960042, December 9,1997; Byrd, Charles, et al. Clinical Study of the Laser Sheath for Lead Extraction: The Total Experience in the United States. Journal of Pacing and Electrophysiology, Vol. 25, No. 5, May 2002; and Wilkoff, Bruce, L., et al. Pacemaker Lead Extraction with the Laser Sheath: Results of the Pacing Lead Extraction with Excimer Sheath (PLEXES) Trial. Journal of the American College of Cardiology, Vol. 33, No. 6, May 1999.

*** WSFX-TV Wilmington, NC, 10/4/2008.