LEIPZIG, Germany and BUELACH, Switzerland ,

24-Month Data from the BIOLUX P-III Registry Show Safety and Efficacy of Passeo-18 Lux DCB, Even in Challenging Patient Subgroups

Results From the World’s Second Largest All-Comers Drug-Coated Balloon Registry Show Continuing Benefit of Passeo-18 Lux in Patients with Critical Limb Ischemia and Diabetes with Positive Outcomes in Terms of Patient Safety

Data from the BIOLUX P-III All-Comers Registry presented at LINC 2019 highlighted the safety and efficacy of BIOTRONIK’s Passeo-18 Lux* drug-coated balloon (DCB), even in challenging patient subgroups. A number of presentations during LINC congress focused on the 24-month results of the all-comers DCB registry, covering aspects such as mortality rates and subgroup analyses of patients with critical limb ischemia (CLI) and diabetes.

During a session dedicated to new data on peripheral DCBs and stents, Prof. Gunnar Tepe, Institute of Radiology, Rosenheim, Germany, presented the 24-month full-cohort data from the BIOLUX P-III registry. The full cohort comprises of 882 enrolled patients. The data reports 88.8% of freedom from clinically-driven target lesion revascularization (fcd-TLR)1. The full cohort of the registry included patients with highly advanced disease states, of which 42.1% were diagnosed as CLI and almost 20% with below-the-knee (BTK) lesions1. Despite the high amount of BTK and complex lesions (32.6% TASC C and D), the major target limb amputation rate remained very low at 7.3% at two years1.



1. Tepe G. BIOLUX P-III Passeo-18 Lux all-comers registry: 24-month results for the full cohort. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.

2. Journal of the American Heart Association. https://doi.org/10.1161/JAHA.118.011245

3. Brodmann M. Twenty-four months outcomes of patients presenting with critical limb ischemia within the BIOLUX P-III registry – a real-world clinical trial treating atherosclerotic arteries with a paclitaxel covered balloon. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.

4. Dahm J.B. Diabetic patients in a real-world clinical trial treated for peripheral arterial disease with a paclitaxel covered balloon. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.


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