Efficacy Data Presented for iVascular’s Luminor DCB
September 18, 2017—iVascular SLU announced that the efficacy of the company's Luminor drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD) was demonstrated in data presented at CIRSE 2017, the annual congress of the Cardiovascular and Interventional Radiological Society of Europe, held September 16–20 in Copenhagen, Denmark.
The Luminor DCB received European CE Mark approval in 2013 to treat superficial femoral, popliteal, and infrapopliteal arteries.
Professor Ulf Teichgräber, MD, presented the results on the primary endpoint of late lumen loss (LLL) and the clinical 6-month results from the full cohort of the EffPAC randomized controlled trial. The data demonstrated the effectiveness of Luminor DCB versus plain old balloon angioplasty (POBA) in the superficial femoral artery. Primary and secondary endpoints were achieved with high statistical significance, stated the company.
The EffPAC randomized controlled trial enrolled 171 patients at 11 centers in Germany. Patients were randomized to treatment with either the Luminor DCB or percutaneous transluminal angioplasty. The 6-month data included a total of 153 patients (77 DCB and 76 percutaneous transluminal angioplasty).
In the DCB group versus the POBA group, respectively, the primary endpoint of LLL was 0.14 mm versus 1.06 mm (P < .001); target lesion revascularization was 1.3% versus 17.1% (P < .001); and primary patency was 94.7% versus 75% (P < .001). Rutherford stages were improved overall for 85.2% of patients in the DCB group versus 75% in the POBA group (P = .021), and by three stages for 44.6% patients in the DCB group versus 27.8% in the POBA group. There were no amputations and no product-related adverse events in the DCB group.
In addition, the company noted that compared with other published randomized controlled trials, the Luminor DCB had demonstrated higher efficacy than most other available DCBs. Prof. Teichgräber stated, “These incomparable outcomes are the result of the innovative coating technology of Luminor DCB, which is shown not only in the patency, LLL, and target lesion revascularization data but also in significant improvement of patients’ clinical status."