iVascular has announced that its Luminor 14m peripheral balloon catheter with paclitaxel elution has received the Canadian Medical Device Licence (MDL).
Luminor 14m is a drug-coated balloon (DCB) with the combination of an extra low cross profile and iVascular proprietary technology for drug release “TransferTech”.
Lluis Duocastella, CEO of iVascular asserted: “The receipt of MDL for Luminor 14m represents a milestone for iVascular on the Canadian market. It opens a new horizon for the endovascular product portfolio and allows us to provide the Canadian market with the best DCB on the market.”
Also during CIRSE, iVascular clinical data were presented from the EffPAC randomised controlled trial. The trial enrolled 171 patients at 11 German centres who were randomised to treatment with either the Luminor DCB or percutaneous transluminal angioplasty. The comparison with other published randomised controlled trials indicated that the Luminor DCB demonstrates higher efficacy than most other available DCBs.