Spectranetics announced on 13 January 2010 publication of the CELLO (CLiRpath Excimer Laser System to enlarge lumen openings) study, which evaluated the effectiveness of excimer laser ablation with the Turbo-Booster, for patients with peripheral artery disease, in the December issue of the Journal of Endovascular Therapy.
The FDA-cleared laser treatment met its primary endpoint by reducing, on average, the percent diameter stenosis from 77.3% to 42.5% immediately post Turbo-Booster use, easily exceeding the goal of a 20% difference. 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-centre study that enrolled 65 patients with claudication. Direct laser ablation was performed on the superficial femoral and popliteal arteries that were at least 70% blocked. The CELLO study demonstrated that 76.7% of patients did not require revascularisation procedures one year post-treatment. Additionally, treatment demonstrated a strong safety profile, with no major adverse events through the six-month follow-up period.
“Preventing the millions of leg amputations caused by peripheral artery disease represents an urgent medical imperative,” said Rajesh Dave, principal investigator of the CELLO trial and chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute at Harrisburg Hospital in Harrisburg, USA. “The best way to preserve limbs is by creating larger blood vessel cavities. 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.”
The CELLO study demonstrated durable objective and subjective functional improvements post-procedure, demonstrating the treatment’s sustained ability to help patient’s return to normal daily activities:
- Walking impairment questionnaire (WIQ): Based on this standard patient self-reported assessment, scores increased from 45.6 to 65.1 – a significant improvement in patients’ perceived mobility.
- Ankle-brachial index (ABI): This objective test, which assesses the ratio of blood flow to the ankle compared to the arm, significantly increased from 0.78 to 0.90 after one year.
- Rutherford category: This physician-assessment score improved significantly from 2.4 to 1.3 over 12 months.
The CELLO study served as the basis for the 2007 FDA clearance of the Turbo-Booster, which offers an enhancement over prior laser ablation techniques. The Turbo-Booster assists the 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.