EFFPAC RCT 24-month has revealed in EuroPCR 2019 that luminor DCB demonstrate a non-increase of risk of death at 24-month follow-up
Barcelona, May 23st, 2019 – EFFPAC RCT 24-month outstanding safety and efficacy results have been presented for the first time at EuroPCR 2019.
The 24-month results from the EFFPAC trial have been presented by Prof Ulf Teichgräber at the Hot line/ Late breaking peripheral trials session.
EFFPAC is a physician initiated multicenter, randomized and controlled trial to assess the effectiveness of luminor paclitaxel-coated balloon versus POBA in the superficial femoral and popliteal arteries to prevent vessel restenosis or reocclusion.
EFFPAC 24-month outcomes:
Primary patency: luminor DCB, 90.2% vs. POBA, 62.7% (p =0.0004)
Freedom TLR, luminor DCB, 97.8% vs POBA: 78.0% (p =0.001)
No increased risk of death detected.
At 24-month, 1 death in the DCB group vs 2 deaths in the POBA group have been notified, maintaining the outcomes from the 12-month follow-up and with a relative risk (RR) of 0.48.
These outcomes are all proving that luminor is the safest and most effective DCB
“luminor maintains the astonishing results and continues to prove its safety through this new 24-month outcomes” stated Prof Teichgräber, PI of the EFFPAC trial,” luminor is one of the most effective DCBs available as of today thanks to its coating technology”.
Not all DCBs are the same. What differentiates luminor DCB from others is iVascular proprietary coating nanotechnology TransferTech.
The paclitaxel used has a microcrystalline structure and, together with the excipient, it is spread on the balloon by ultrasound spray pulse.
The balloon surface is covered with multiple and independent nanodrops layers.
Such unique and innovative technology, provides a flexible coating, adapting to the balloon movement.
About Luminor DCB
luminor is a Paclitaxel Coated Balloon specifically 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.