iVascular's Luminor 14m DCB Approved in Canada
September 21, 2017—iVascular S.L.U. announced that it has received the Canadian Medical Device License for the company's paclitaxel-eluting Luminor 14m peripheral balloon catheter for percutaneous transluminal angioplasty. The Luminor 14m drug-coated balloon (DCB) combines an extra-low crossing profile and iVascular's TransferTech technology for drug release.
According to the company, the nanotechnology in Luminor minimizes drug loss during navigation and enhances delivery to the artery wall. The device is available with 0.014-inch, 0.018-inch, and 0.035-inch guidewire compatibility. The Luminor DCB received the European CE Mark approval in 2013 to treat superficial femoral, popliteal, and infrapopliteal arteries. It is available in more than 50 countries.
On September 18, the company announced that the clinical data from the full cohort of the EffPac randomized controlled trial demonstrating the efficacy of the Luminor DCB in patients with peripheral arterial disease were presented by Professor Ulf Teichgräber, MD, at CIRSE 2017, the annual congress of the Cardiovascular and Interventional Radiological Society of Europe, held September 16–20 in Copenhagen, Denmark.