Biotronik expands DCB line with CE Mark for Passeo-18 Lux

Biotronik said today it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries. The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval for the device was based on the randomized, controlled Biolux P-I clinical trial, with results published in the Journal of Endovascular Therapy. “Effective treatment of infrapopliteal arterial disease is quite challenging as it involves high-risk patients with severe comorbidities and critical limb ischemia, poor prognoses and considerable mortality rates. Unfortunately, there is a lack of study data available regarding use of DCB in this complex area, and results have been somewhat contradictory. The results of the Biolux P-II trial are, however, encouraging. During the trial, Passeo-18 Lux paclitaxel-coated balloon catheter demonstrated safety and performance in the treatment of stenosis, restenosis and occlusion below-the-knee,” trial investigator Dr. Marianne Brodman of Austria’s Medical University Graz said in a press release. Data from the more recent Biolux-PII clinical trial indicated that after 6 months, patients treated with the Passeo-18 Lux had higher primary patency, greater improvements on the Rutherford Classification scale and no major adverse events at 30 days when compared to patien...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Catheters Drug-Device Combinations Regulatory/Compliance Vascular Biotronik Source Type: news