London, April 25th, 2018 – EFFPAC RCT 12-month outstanding results with Luminor DCB have been revealed at CX Symposium 2018.
The 12-month results from the full clinical cohort of the EFFPAC randomized controlled trial (RCT), were presented for the first time at CX Symposium 2018 at the DCB session on April 24th.
Main objective was to assess the effectiveness of Luminor drug coated balloon (DCB) vs. Uncoated balloon catheter (POBA), in the superficial femoral and popliteal arteries. The EFFPAC RCT 12-month outcomes are all demonstrating high statistical significance versus POBA, therefore confirming and even maintaining, the already excellent 6-month outcomes:
- Primary endpoint: Late Lumen Loss (LLL) at 6 months: 0.14mm (vs 1.06mm in POBA group, p<0.001)
- Target Lesion Revascularization (TLR) at 12 months: 1.3% (vs 17.7% in POBA group, p<0.001)
- Primary Patency (PP) at 12 months: 90.3% (vs. 65.3% in POBA group, p<0.001)
- Rutherford stage improvement at 12 month: 90.6% Luminor group (p=0.006)
“What is so special about Luminor DCB, is its unique nano-coating technology, which is ultra-thin and uniform” commented Professor Ulf Teichgräber (Jena University, Germany), principal investigator of the study, who also stated that “Luminor provides the best DCB outcomes, according to comparison of EFFPAC with trials of similar design.”
“We are very happy about EFFPAC 12-month outcomes, which are confirming that Luminor superior efficacy is maintained over time” said Lluis Duocastella, CEO of iVascular SLU.
“Our TransfertechTM coating technology is now a proven added value to provide the best to the patients”
About Luminor DCB & 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.