EFFPAC-RCT 12-month results will be presented for the first time at CX Symposium 2018

Barcelona, March 8th, 2018 – EFFPAC-RCT 12-month results will be presented for the first time on April 24th at CX Symposium 2018

The 12-month results from the full clinical cohort of the EFFPAC randomized control trial (RCT), comparing the Luminor DCB (iVascular) to POBA, are going to be presented for the first time at Charing Cross International Symposium 2018 in London. Professor Ulf Teichgräber, M.D., Director of the Department of Radiology at the University Hospital Jena (Germany) and Principal Investigator (PI) of the study, will expose the conclusions during the Drug-coated balloons session on Tuesday 24th.

The excellent 6-month data has set high expectations for the 12-month results.

EFFPAC 6-month results:

  • Primary and secondary endpoints were achieved with high statistical significance.
  • Primary endpoint revealed a late lumen loss of 0.14mm in the DCB group vs 1.06mm in the POBA group (p<0.001).
  • Target Lesions Revascularization was 1.3% (DCB) vs 17.1% (POBA) (p<0.001).
  • Primary Patency (PP) was 94.7% (DCB) vs 75.0% (POBA) (p<0.001).
  • Rutherford stages were overall improved for 85.2% patients (DCB) vs 75.0% (POBA) (p=0.021), and by 3 stages for 44.6% patients (DCB) vs 27.8%.

 “We are proud to continue to innovate and provide physicians with the latest technology to improve patients’ outcomes” said Lluis Duocastella, CEO of iVascular SLU.

About Luminor Drug-Coated Balloon & Transfertech technology

 

Luminor is a paclitaxel coated balloon with an innovative and proprietary coating, using unique nanotechnology for minimized drug loss during navigation and enhanced delivery to the artery wall. Full range is available with 0.014”, 0.018” and 0.035” guidewire compatibility, providing ultra-low profile and fast deflation time.

Transfertech is a proprietary technology of iVascular for the coating of drug eluting balloons. It has the capability of applying a uniform dosage of the drug by ultrasonic depositions of uniform diameter nanodrops.

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