RANGER™

Paclitaxel-Coated PTA Balloon Catheter

The Ranger Drug Coated Balloon has been studied in over 250 patients, in both randomized and real-world clinical trials.

Ranger SFA RCT

Study Design

  • Randomized, controlled trial
  • Multicenter, 10 centers in Europe
  • External, blinded core lab adjudication
  • N = 105
Baseline Characteristics (Core Lab Adjudicated)

Efficacy & Safety Results

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

  • Ranger achieved a 91% Freedom from TLR at 12 months
  • Ranger demonstrated Freedom from TLR superior* to PTA
 
12 month Data Sheet
 
 

Ranger All Comers Registry¹

Study Design

  • Multicenter registry,
  • Planned enrollment of 180 patients
Baseline Characteristics
Rutherford Clinical Category
  • Average lesion length: 135 mm
  • Diabetes: 34 %
  • Rutherford: 80 % Class III & higher
  • TASC C&D: 59 %
  • Percent diameter stenosis: 91 %

 

Safety & Efficacy results

Freedom from TLR at 6 months
Kaplan-Meier Estimate
  • 91.9%² freedom from TLR at 6 months
  • 91.1%² primary patency at 6 months

 

Patient Outcomes

  • 91% of patients improved by at least 1 Rutherford category at 6 Months
  • 80% of patients improved ≥2 Rutherford categories at 6 Months

 

 
Rutherford Category
 
 

Ranger Clinical Data Summary

  • The Ranger DCB has been studied in over 250 patients, in both randomized and real-world clinical trials.
  • The Ranger SFA-RCT has achieved among the highest FTLR of 91% and Primary Patency of 86% at 12 months.
  • The Ranger All-Comers Registry confirms benefit of an efficient drug coating technology in challenging, real-world lesions with FTLR of 91.9%² and Primary Patency of 91.1%² at 6 months.

 

Ranger Clinical Data Brochure

 

 

Ranger Drug-Coated Balloon JACC Results

 

 

New comparative Drug Coated Balloon study in JACC's July issue


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.
 

Comparison of Different Drug Coated Balloons on Tissue Pharmacokinetics and Vascular Healing in In Stent Restenosis (ISR) Swine Model

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.
Clincal data Picture
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.

Main conclusion:
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.

 
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