iVascular’s Luminor and iVolution Devices Evaluated for Combined Therapy in 4-Year TINTIN Data

July 6, 2023—iVascular announced 4-year outcomes from the investigator-initiated TINTIN trial assessing combination therapy with the company’s Luminor paclitaxel-eluting percutaneous transluminal angioplasty balloon dilatation catheter and its iVolution Pro self-expanding stent. The trial’s Principal Investigator, Koen Deloose, MD, of AZ Sint Blasius in Dendermonde, Belgium, presented the data at LINC, the Leipzig Interventional Course, held June 6-9 in Leipzig, Germany.

According to iVascular, the prospective TINTIN trial enrolled 100 patients with TASC (TransAtlantic Inter-Society Consensus) C and D lesions in the femoropopliteal segment. These real-life complex lesions included long lengths (24.3 cm) with high percentages of calcifications (73% moderate–severe) and occlusions (60%). Completion of enrollment in the TINTIN trial was announced by iVascular in November 2018.

At LINC, Dr. Deloose reported the trial’s efficacy outcome of 74.8% freedom from clinically driven target lesion revascularization.

In iVascular’s press release, Dr. Deloose stated that the combined use of a drug-coated device and a scaffold “seems to be, in the longer run, the perfect solution for complex lesion treatment.”

The Luminor catheter is indicated for the dilation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial.

The iVolution Pro stent system is indicated for the treatment of de novo or restenotic atherosclerotic lesions in peripheral arteries located under the aortic arch and to palliate malignant strictures of the biliary tract, advised the company.