iVascular EffPAC 6 Months Outstanding Data Presented at CIRSE 2017 DCB Session
iVascular EffPAC 6 Months Outstanding Data Presented at CIRSE 2017 DCB Session:
Copenhagen – September 18, 2017 – iVascular SLU data announced today, demonstrate the efficacy of the Luminor drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD). The 6 months results from the full clinical cohort of the EffPAC randomized study were presented in the DCB session at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2017 conference in Copenhagen.
EffPAC Randomized Study
Professor Ulf Teichgräber, M.D., director of the Departement of Radiology of the University Hospital Jena, Germany, presented the new, primary endpoint late lumen loss and the clinical six-months results from the full cohort of the EffPAC Randomized Control Study, demonstrating the effectiveness of Luminor DCB versus POBA in the SFA.
Primary and secondary endpoints were achieved with high statistical significance:
- Primary endpoint revealed a late lumen loss (LLL) of 0.14mm in the DCB group vs 1.06mm in the POBA group (p<0.001).
- Target Lesions Revascularization (TLR) 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% (POBA)
There was no amputation nor any product related adverse event in the DCB group.
The comparison with other published RCTs, underlined that Luminor DCB demonstrates higher efficacy than most other available DCBs. As stated by Prof. Ulf Teichgräber “These incomparable outcomes are the result of the innovative coating technology of Luminor DCB, which is shown not only in the patency, LLL and TLR data, but also in significant improvement of patients’ clinical status”.