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Freedom from TLR of 94.4% at 6 months, with significantly less late lumen loss vs. PTA.
Late Lumen Loss (mm)
Late Lumen Loss
Freedom From TLR at 6 Months1
Similar Adverse Event and Serious Adverse Event rates between groups
Rutherford Clinical Category
Freedom from TLR at 6 months
Impact of Paclitaxel Dose on Tissue Pharmacokinetics and Vascular Healing: A Comparative Drug Coated Balloon Study in the Familial Hypercholesterolemic Swine Model of Superficial Femoral In-Stent Restenosis. C.A. Gongora MD and all.
This study leaded by Dr. Juan Granada aimed to compare the effect of PCB concentration on tissue levels and vascular healing using 3 different PCB technologies (In.Pact™ Pacific= 3.5 µg/mm² , Lutonix™ = 2 µg/mm² and Ranger™= 2 µg/mm²) in the experimental setting³.
Angiographic late lumen loss was lowest in Ranger balloon (0.51 ± 0.42 mm) compared to In.Pact (0.65 ± 0.74 mm) and Lutonix (0.91 ± 0.3 mm) (P-Value < 0,05).³
In the bench top study, the Ranger PCB had fewer observable particles than either Lutonix or In.PACT Pacific. In the quantitative analysis, the average number of large particles (<300 μm) was approximately 6 to 8 times lower compared to both Lutonix and In.PACT Pacific⁴.
Compared to POBA (Plain old balloon angioplasty) all tested Drug-Coated Balloons demonstrated efficacy (decreased Neointimal inhibition thickness and percent stenosis). The In.Pact DCB provided strongest neointimal inhibition but less complete healing⁴.
The Ranger DCB technology demonstrated sustained tissue retention at lower loading doses with less particulate formation, but with an efficacy profile comparable to the already clinically proven first-generation DCB technologies.