Biotronik's Smaller-Diameter Passeo-18 Lux DCBs Gain CE Mark Approval to Treat BTK Disease

January 26, 2016—Biotronik announced that it has received European CE Mark approval for smaller diameters of the company’s Passeo-18 Lux drug-coated balloon (DCB). The newly available 2- and 2.5-mm sizes are designed to facilitate DCB treatment of below-the-knee arteries with an 0.018-inch platform.  

The safety and efficacy of the Passeo-18 Lux paclitaxel-coated balloon catheter in the treatment of peripheral arterial disease was established by the randomized, controlled BIOLUX P-I clinical trial. The results are comparable to other scientific data suggesting that DCB is a viable treatment option and has the potential to become the standard of care in the superficial femoral artery. Dierk Scheinert, MD, et al published the 12-month BIOLUX P-I data in the Journal of Endovascular Therapy (2015;22:14–21).

The company advised that use of the Passeo-18 Lux in infrapopliteal arteries is supported by promising data from the multicenter, randomized, controlled BIOLUX P-II first-in-human clinical trial. As reported in October 2015, Principal Investigator Thomas Zeller, MD, et al published the BIOLUX P-II findings in the Journal of American College of Cardiology: Cardiovascular Interventions (2015;8:1614–1622). 

According to Biotronik, the first results of the trial showed a trend toward more favorable outcomes for patients treated with Passeo-18 Lux DCB as compared to conventional percutaneous transluminal angioplasty (PTA). At 6 months, primary patency for Passeo-18 Lux patients was 82.9% versus 73.9% in the PTA group. In the DCB group, 59% of patients improved in Rutherford Classification versus 47% in the PTA group. Additionally, patients in the DCB group did not experience any major adverse events at 30 days and had a low major amputation rate of 3.3% versus 5.6% in the PTA group at 12 months.

In Biotronik’s press release, BIOLUX P-II investigator Marianne Brodmann, MD, from the Medical University Graz, Austria, commented, “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.” 

Use of Passeo-18 Lux for below-the-knee indications will continue to be investigated. The BIOLUX P-III Global All-Comers Registry plans to enroll more than 700 patients, including a dedicated below-the-knee indication subgroup. BIOLUX P-III is currently enrolling patients in Europe and Asia Pacific. Six-month results of the registry are to be presented during a scientific symposium at LINC 2016, the Leipzig Interventional Course being held January 26–29 in Leipzig, Germany.