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 patients treated with conventional percutaneous transluminal angioplasty.
“Since receiving CE mark in 2013, Passeo-18 Lux has repeatedly proven itself in clinical trials, gaining the trust of physicians around the world. Along with our rigorous clinical program, the addition of smaller diameters to the Passeo-18 Lux DCB portfolio further establishes our brand as a leader in lower limb therapies,” vascular intervention marketing veep Dr. Alexander Uhl said in a prepared statement.
The company said it is continuing to investigate the use of the Passeo-18 Lux for below-the-knee indications, with plans to enroll 700 patients in its Biolux P-III global all-comers registry study.
Biotronik won initial CE Mark approval for its Passeo-18 Lux DCB in January 2014, with indications for treating de novo and restenotic femoropopliteal lesions.