Affluent Medical releases impressive results from SCOPE 1 clinical trial validating efficacy of KARDIOZIS technology
- Outstanding results from SCOPE 1 randomized, controlled, multicentric clinical trial, proving the efficacy of treating life-threatening Abdominal Aortic Aneurysm (AAA), by thrombogenic fibers embolization of the aneurysm sac when performing an EndoVascular Aneurysm Repair (EVAR).
- No complications related to thrombogenic fibers embolization were observed.
- Rate of repeat surgery and endoleaks was significantly reduced in the Study group Vs Control Group from 78% to 47% at 24 months (p= 0.003).
- A significant reduction of aneurysm volume of 55% was observed in patients in the Study Group Vs Control Group at 24 months (p=0.001).
Impressive validation of the proprietary KARDIOZIS one-step technology under development, with thrombogenic fibers pre-linked to prosthesis and so introducing a quantum leap innovation in the treatment of abdominal aortic aneurysm, which affects 5 to 10% of men from age 65 to 80.