COMPARE Clinical Trial1

World’s first head-to-head, prospective, multi-center, Randomized Controlled Trial (1:1) comparing the low dose Paclitaxel RANGER™ DCB (2 µg/mm2) to the higher dose Paclitaxel IN.PACT™ DCB (3.5 µg/mm2)

12 Month Primary Patency Results
  1. COMPARE Clinical Trial 12-Month Results presented by Sabine Steiner, MD. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 83.0% for Ranger DCB and 81.5% for IN.PACT DCB (Pnon-inferiority <0.01). Freedom from Major Adverse Events = 91.0% for Ranger DCB and 92.6% for IN.PACT DCB (Pnon-inferiority <0.01).

12-Month Kaplan-Meier Primary Patency

89.8%

versus PTA (74.0%)

Ranger II SFA Pivotal Trial2

Objective: To prove superior performance of the Ranger paclitaxel-coated PTA balloon catheter for angioplasty of femoropopliteal artery lesions when compared to standard PTA balloons.

  1. RANGER II SFA Pivotal Trial 12-Month Results presented by Marianne Brodmann. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 82.9% for Ranger DCB and 66.3% for PTA (p= <0.0017). Freedom from Major Adverse Events = 94.1% for Ranger DCB and 83.5% for PTA (Pnon-inferiority<0.0001).

Balloon Platform

Ranger is built on the market leading3 .018” Sterling Balloon Platform and is .014/.018” guidewire compatible.

3. DRG data, CY 2019, .018” PTA Balloons.
Ranger .018

 

Efficient Drug Transfer

TransPax (Citrate Ester + Low Dose Paclitaxel1) is a next generation coating that efficiently transfers drug into the tissue, resulting in patency near 90%2 while reducing downstream particulates3 and systemic drug exposure for the patient4

 

 
Efficient Drug Transfer image
  1. Drug dose density = 2 μg/mm2
  2. COMPARE Clinical Trial 12-Month Full Cohort Results presented by Sabine Steiner, MD. LINC 2020. K-M Primary Patency = 88.4%.
    RANGER II SFA Pivotal Trial 12-Month Results presented by Marianne Brodmann. LINC 2020. K-M Primary Patency = 89.8%
  3. Gongora et al. Comparative Drug-Coated Balloon Study. JACC Cardiovasc Interv. 2015 doi.org/10.1016/j.jcin.2015.03.020
  4. RANGER II SFA PK Substudy presented by Ravish Sachar, MD. VIVA 2019.

 

CAUTION: Ranger is an Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. 
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