Smaller diameters gain CE approval for enhanced treatment of below-the-knee arterial disease
BIOTRONIK, a leader in cardio and endovascular medical technology has announced it has received CE mark approval for smaller diameters of its Passeo-18 Lux drug-coated balloon (DCB).
The newly-available 2mm and 2.5mm sizes facilitate DCB treatment of below-the-knee arteries with the same minimally-invasive .018'' platform, thus completing the Passeo-18 Lux portfolio and granting physicians enhanced options for treating this complex patient population.
The safety and efficacy of the Passeo-18 Lux paclitaxel-coated balloon catheter in treatment of peripheral arterial disease (PAD) was established by the randomised, controlled BIOLUX P-I clinical trial. 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-center, 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)2. At six months, primary patency for Passeo-18 Lux patients was 82.9% vs. 73.9%in the PTA group. 59% 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% vs. 5.6% 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,” said BIOLUX P-II investigator and main enroller, Dr Marianne Brodmann of the 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.
“Since receiving CE mark in 2013, Passeo-18 Lux has repeatedly proven itself in clinical trials, gaining the trust of physicians around the world,” said Dr Alexander Uhl, BIOTRONIK vice president for marketing for vascular intervention.
“Along with our rigorous clinical program,e, the addition of smaller diameters to the Passeo-18 Lux DCB portfolio further establishes our brand as a leader in lower limb therapies.”
Passeo-18 Lux is a novel combination device for treating de novo and restenotic lesions in the infrainguinal arteries. Its design is based on that of the proven Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of anti-proliferative paclitaxel and butyryl-tri-hexyl citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue.
This coating is also applied to Pantera Lux, a clinically-proven coronary drug-coated balloon. Passeo-18 Lux also features the unique SafeGuard insertion aid, which improves ease of handling and protects the user and balloon coating from contact and damage. After use, SafeGuard can simply be peeled away.