CE mark approval has been granted to Biotronik for smaller diameters of the Passeo-18 Lux drug-coated balloon (DCB). The new sizes—2mm and 2.5mm—are designed to facilitate DCB treatment of below-the-knee arteries.
The products are intended for use with the minimally invasive 0.8” Passeo-18 Lux platform.
The randomised, controlled BIOLUX P-I clinical trial established the safety and efficacy of the Passeo-18 Lux paclitaxel-coated balloon catheter in treatment of peripheral arterial disease (PAD).
These results, published in the Journal of Endovascular Therapy, are comparable to other scientific data suggesting that DCB is a viable treatment option and has the potential to become standard of care in the superficial femoral artery (SFA), according to a Biotronik press release.
The encouraging results, published in the Journal of Endovascular Therapy, are comparable to other scientific data suggesting that DCB is a viable treatment option and has the potential to become standard of care in the superficial femoral artery (SFA).
Unlike other DCBs, use of Passeo-18 Lux in infrapopliteal arteries is also supported by promising data from the multi-centre, randomised, controlled BIOLUX P-II first-in-human clinical trial, published in the Journal of American College of Cardiovascular Intervention in October 2015.
First results showed a trend towards more favourable outcomes for patients treated with Passeo-18 Lux DCB as compared to conventional percutaneous transluminal angioplasty (PTA). At six months, primary patency for Passeo-18 Lux patients was 82.9% vs. 73.9% in the PTA group.
Fifty-nine per cent of patients improved in Rutherford Classification in the DCB group vs. 47% in the control group. Finally, patients in the DCB group did not experience any major adverse events (MAE) at 30 days, and had a low major amputation rate at 12 months: 3.3 percent vs. 5.6 percent in the control group.
“Effective treatment of infrapopliteal arterial disease is quite challenging as it involves high-risk patients with severe comorbidities and critical limb ischemia (CLI), poor prognoses and considerable mortality rates,” states BIOLUX P-II investigator and main enroller Marianne Brodmann, Medical University Graz, Austria. “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, as the BIOLUX P-III Global All-comers Registry plans to enrol over 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 will be presented during a scientific symposium at LINC 2016 in Leipzig.