January 28, 2020
One-Year TINTIN Data Presented for iVascular’s Luminor DCB and iVolution Stent
January 28, 2020—iVascular, based in Barcelona, Spain, announced that 1-year clinical outcomes of the TINTIN trial were presented by Principal Investigator Koen Deloose, MD, at LINC 2020, the Leipzig Interventional Course held January 28–31 in Leipzig, Germany.
According to the company, TINTIN is a physician-initiated, prospective, single-arm multicenter study conducted in Belgium. TINTIN is investigating the safety and efficacy of the treatment with iVascular’s Luminor drug-coated balloon (DCB) and iVolution self-expanding stent in TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal atherosclerotic lesions with a 240-mm average length.
The Luminor DCB is a paclitaxel-coated balloon specifically designed for dilatation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries. It is also intended for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial. The iVolution peripheral self-expanding stent system is indicated for the treatment of de novo or restenotic lesions in peripheral arteries located under the aortic arch and for palliation of the biliary tract.
iVascular reported that the TINTIN 1-year outcomes demonstrated primary patency of 90.5% with freedom from target lesion revascularization of 94.4%. Safety has been proved with zero device-related deaths.
In his presentation, Dr. Deloose stated, “The combination of Luminor DCB and iVolution self-expanding stent shows impressive 1-year outcomes in the TINTIN trial, comparable to [drug-eluting stents] but in more complex lesions.” Dr. Deloose, who is Head of Department of Vascular Surgery at AZ Sint Blasius in Dendermonde, Belgium, enrolled the first patients in the TINTIN trial in September 2017.
Last year, Dr. Delouse presented the 6-month results of the TINTIN study at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiology Society of Europe held in Barcelona.