Two-Year Data Presented From EffPac Trial of iVascular's Luminor DCB

 

May 23, 2019—iVascular announced that the 24-month EffPac trial results were presented by Professor Ulf Teichgräber, MD, at EuroPCR held May 21–24 in Paris, France.

EffPac is a physician-initiated, multicenter, randomized controlled trial (RCT) assessing the safety and efficacy of iVascular's Luminor paclitaxel drug-coated balloon (DCB) versus plain old balloon angioplasty (POBA) in the superficial femoral and popliteal arteries to prevent vessel restenosis or reocclusion.

The company reported the following 24-month outcomes from EffPac on the Luminor DCB versus POBA:

  • Primary patency of 90.2% vs 62.7% (P = .0004)
  • Freedom target lesion revascularization of 97.8% vs 78% (P = .001)
  • No increased risk of death detected with 1 vs 2 deaths, which maintains the outcomes from the 12-month follow-up and with a relative risk of 0.48.

In iVascular's announcement, Prof. Teichgräber, Principal Investigator of the EffPac trial, commented, “Luminor maintains the astonishing results and continues to prove its safety through this new 24-month outcomes. Luminor is one of the most effective DCBs available as of today thanks to its coating technology.”

According to the company, the Luminor DCB is designed for dilatation 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 device features iVascular's TransferTech coating nanotechnology. The paclitaxel used has a microcrystalline structure, and together with the excipient, it is spread onto the balloon by ultrasound spray pulse. The balloon surface is covered with multiple independent nanodrops layers. This technology provides a flexible coating that adapts to the balloon's movement, noted iVascular.

 

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