May 10, 2016
Spanish Registry Evaluates iVascular's Luminor Drug-Coated Balloon
May 11, 2016—Preliminary results from a multicenter Spanish registry of lower limb ischemia treated with iVascular’s Luminor drug-coated balloon (DCB) were announced by the company, which is based in Barcelona, Spain.
According to iVascular, the Luminor DCB is a coaxial catheter designed for percutaneous transluminal angioplasty of peripheral arteries, with versions for 0.014-, 0.018-, and 0.035-inch guidewires. The balloon is coated with a homogeneous mixture of paclitaxel and a physiologically innocuous matrix as an excipient.
The drug dose is 3 µg/mm2 and is intended to prevent restenosis, consequently decreasing the rate of target lesion revascularization (TLR). The coating is applied using iVascular’s Transfertech technology, which is based on a spray dosage system of drug nano-drops. The overall result is a thin, multilayer coating with amicrocrystalline structure that enhances drug transfer to the arterial wall.
The Luminor registry is an observational, prospective, multicenter study with single-arm treatment for native stenotic or occlusive lesions or in-stent stenosis of the femoropopliteal (FP) and below-the-knee (BTK) vessels. The objective was to evaluate the performance of the Luminor DCB in terms of primary patency and freedom of serious adverse events. A maximum of 250 Rutherford class 2 to 5 cases will be recruited following an intention-to-treat basis.
The company reported that since the fourth quarter of 2014, 143 patients with 165 lesions (81 chronic total occlusions with a mean length of 7.2 ± 5.8 cm; 84 stenoses with a mean length of 5.9 ± 4.5 cm) have been included and monitored. Injury locations were 101 FP, 36 BTK, and 14 FP + BTK.
There were seven cases of in-stent stenosis. Eighty-two patients (57.3%) were classified as Rutherford class 5. Technical success was achieved in 99.7% of the cases. Bailout stenting was necessary in 13 lesions (7.8%). At 6 months, the cumulative primary patency rate was 85.3%. Ninety-six patients completed 6-month follow-up. For those patients, 30-day mortality was 1.4%, with eight major amputations (8.3%) and six cases of TLR (6.3%; freedom TLR, 93.7%).
The investigators concluded that the results of the initial primary endpoints are encouraging, even in patients with highly severe ischemic status. Interim and final results will be published in future reports, advised iVascular.