The Passeo-18 Lux Drug-Coated Balloon is indicated to dilate de novo or restenotic lesions in the infrainguinal arteries* through a low profile** balloon platform. Its technologies allow an effective drug delivery1: The SafeGuard® Insertion Aid reduces drug loss in the introducer sheath up to 94% and protects user and balloon from contact and damage, while the Lux® Coating (Paclitaxel and BTHC) optimizes drug transfer and ensures high drug retention at the lesion site.
BIOTRONIK announced the one-year subgroup results from the investigator-initiated BIOPACT randomized controlled trial (RCT), which were presented by principal investigator Dr. Koen Deloose at LINC, the Leipzig Interventional Course 2023. The randomized controlled non-inferiority trial evaluated the safety and efficacy of the Passeo®-18 Lux® drug-coated balloon (DCB) catheter compared to the In.Pact Admiral DCB (Medtronic) and showed excellent results for both balloons through 12 months across a variety of sub-cohorts. The prospective, multicenter, core-lab adjudicated non-inferiority study enrolled 302 patients in Austria, Belgium, France and Switzerland with Rutherford 2-4 disease.1 Patients were randomized 1:1 to either the Passeo-18 Lux DCB or In.Pact Admiral DCB for the treatment of stenotic, non-stented restenotic or occlusive lesions in the femoropopliteal artery.1 The primary safety endpoint was a composite of freedom from device- and procedure-related death through 30 days post-index procedure
BIOTRONIK announced the presentation of two-year results from the investigator-initiated BIOPACT RCT by Principal Investigator Dr. Koen Deloose at the Paris Vascular Insights 2023 congress. The randomized controlled non-inferiority trial evaluated the safety and efficacy of the Passeo®-18 Lux® drug-coated balloon (DCB) catheter compared to the In.Pact Admiral DCB (Medtronic), and showed excellent results for both balloons through 24 months.1 The prospective, multicenter, core-lab adjudicated non-inferiority trial enrolled 302 patients in Austria, Belgium, France and Switzerland with Rutherford Class 2-4 disease. Patients were randomized 1:1 to either the Passeo-18 Lux DCB or In.Pact Admiral DCB for the treatment of stenotic, non-stented restenotic or occlusive lesions in the femoropopliteal artery. Baseline patient and lesion characteristics were comparable across both arms. As presented at Paris Vascular Insights in November 2023, the rate of clinically driven target lesion revascularization (CD-TLR)
Pantera Lux Coronary Drug-Coated Balloon (DCB) is indicated for balloon dilatation for in-stent restenosis, de novo lesions, acute or impending vascular occlusion and treatment of small vessel disease.a
Passeo-18 is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.*
With usable lengths up to 170cm, Passeo-35 Xeo balloon allows a radial approach1 to dilate stenosis in the iliac*, femoral, popliteal and infrapopliteal arteries. Passeo-35 Xeo balloon is also recommended for post-dilation of stents in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.**
To collect long-term clinical data on patients treated with either Passeo-18 PTA or Passeo-18 Lux DCB
Passeo-35 HP is a unique high pressure PTA Balloon to dilate most resistant lesions in complex anatomy.1 It is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.*
