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Freedom from TLR of 91% at 12 months, with significantly less late lumen loss vs. PTA.
Late Lumen Loss (mm)
Late Lumen Loss
Freedom From TLR at 12 Months*
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 led 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.
Bare metal stent ISR model
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 slightly higher levels of neointimal inhibition but also reduced neointimal maturity and higher fibrin deposition.3
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.