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”.
The EffPAC RCT enrolled 171 patients at 11 German centres who were randomized to treatment with either the Luminor DCB or PTA. The 6 months data includes a total of 153 patients (77 DCB and 76 PTA).
“EffPAC results are reinforcing the positive outcomes of the LUMINOR Registry” said Lluis Duocastella, CEO of iVascular SLU. “We are proud to continue to innovate and provide physicians with the latest technology to improve patients‘ outcomes”.
About Luminor Drug-Coated Balloon
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.
Luminor DCB received the CE (Conformité Européenne) Mark in 2013 to treat superficial femoral, popliteal and infrapopliteal arteries. It is available in more than 50 countries. Pre-clinical study, as well as LUMINOR registry, have already demonstrated safety and efficacy in complex lesions.