Six-Month Results Presented From TINTIN Trial of iVascular’s Luminor DCB and iVolution BMS

 

September 24, 2019—iVascular, based in Barcelona, Spain, announced that 6-month results of the TINTIN study were presented by Principal Investigator Koen Deloose, MD, at CIRSE 2019, the annual conference of the Cardiovascular and Interventional Radiology Society of Europe held September 7–11 in Barcelona.

Conducted in Belgium, TINTIN is a prospective, physician-initiated, nonrandomized, multicenter trial evaluating the 12-month safety and efficacy of combined therapy of iVascular’s Luminor drug-coated balloon (DCB) and its iVolution bare-metal stent (BMS) for the treatment of TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal atherosclerotic lesions.

iVascular reported that the TINTIN trial outcomes included primary patency of 96.5% and freedom from target lesion revascularization of 98.9%. In his presentation at CIRSE, Dr. Deloose concluded, “The Belgian TINTIN trial shows impressive 6-month results in lesions of 24 cm.” 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.

According to the company, both the iVolution and Luminor devices demonstrated excellent outcomes in TASC A and B lesions; however, as indicated in the literature, neither BMS nor DCB alone are sufficiently effective in long, complex lesions and in the long term. The TINTIN findings show that the combination of both devices is the key to success in these situations.

iVascular advised that the Luminor 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 Luminor DCB was evaluated in the EffPac trial. EffPac is a physician-initiated, multicenter, randomized controlled trial assessing the safety and efficacy of the Luminor versus plain old balloon angioplasty in the superficial femoral and popliteal arteries to prevent vessel restenosis or reocclusion. The 24-month EffPac trial results were presented by Professor Ulf Teichgräber, MD, at EuroPCR 2019 held May 21–24 in Paris, France.

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 biliary tract. The outcomes of the EVOLUTION trial demonstrated the flexibility and high-quality nitinol of the stent, supporting iVolution as an effective alternative to treat femoropopliteal lesions.

 

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