Published CELLO Study Demonstrates Effectiveness of Spectranetics’ Turbo-Booster Excimer Laser Ablation System

January 13, 2010—Spectranetics Corporation (Colorado Springs, CO) announced that Rajesh M. Dave, MD, et al have published results of the CELLO (Clirpath Excimer Laser System to Enlarge Lumen Openings) registry in the Journal of Endovascular Therapy (2009;16:665–675). CELLO evaluated the effectiveness of excimer laser ablation with the company's Turbo-Booster for patients with peripheral arterial disease (PAD).

The CELLO study served as the basis for the 2007 clearance of the Turbo-Booster from the US Food and Drug Administration. The device assists Spectranetics’ Turbo Elite laser catheter in delivering excimer laser energy to more of the target lesion. By rotating the laser catheter within the blood vessel, the Turbo-Booster enables ablation of more plaque than is possible with the catheter alone.

According to the company, the Turbo-Booster laser treatment met the CELLO trial’s primary endpoint by reducing, on average, the percent diameter stenosis from 77.3% to 42.5% immediately after treatment. Additionally, the Turbo-Booster had a low number of repeat vascular interventions while safely improving a range of clinical and functional status assessments.

The CELLO study is a prospective, 17-center study that enrolled 65 patients with claudication caused by PAD. Direct laser ablation was performed on superficial femoral and popliteal arteries that were at least 70% blocked. The company noted that it is common for these patients to require frequent revascularization of the target artery blockage. However, the CELLO study demonstrated that 76.7% of patients did not require revascularization procedures at 1 year after treatment. Additionally, treatment demonstrated a strong safety profile, with no major adverse events through the 6-month follow-up period, the company noted.

Spectranetics stated that the CELLO study also demonstrated durable objective and subjective functional improvements postprocedure, demonstrating the treatment's sustained ability to help patients return to normal daily activities. Walking impairment questionnaire scores increased from 45.6 to 65.1, which indicates a significant improvement in patients’ perceived mobility. Also, the ankle-brachial index significantly increased from 0.78 to 0.9 after 1 year. Further, the Rutherford category score improved significantly from 2.4 to 1.3 over 12 months.

"Preventing the millions of leg amputations caused by PAD represents an urgent medical imperative," commented Dr. Dave, principal investigator of the CELLO trial. "This study demonstrated the Turbo-Booster’s ability to produce larger lumens than what was previously achieved by excimer laser catheters alone. This may help reduce the need for aggressive adjunctive therapy, like stenting."