SCOPE I Trial Evaluates Affluent Medical's Kardiozis Technology for EVAR
February 20, 2019—Affluent Medical announced that results from the SCOPE 1 clinical trial validating the efficacy of the company's Kardiozis technology were presented by Principal Investigator Professor Dominique Fabre, MD, at CACVS, the Controversies And Updates in Vascular Surgery Congress, held February 7–9 in Paris, France.
Affluent Medical stated that the Kardiozis device, which is currently in preclinical development, is designed to help reduce endoleaks and the size of the aneurysm, and then prevent their occurrence. The device's one-step technology features thrombogenic fibers prelinked to a prosthesis for the treatment of abdominal aortic aneurysm. The company advised that a European launch of the device is anticipated for 2021.
SCOPE 1 is a controlled, randomized, prospective, multicenter clinical trial evaluating the efficacy and clinical outcomes of embolization of the aneurysm sac using thrombogenic fibers when performing a conventional endovascular aneurysm repair (EVAR).
As reported by the company, the study has enrolled 102 patients in two arms, with data records analyzed from 91 patients: 45 patients in the control group of patients implanted with EVAR only and 46 patients in the study group of patients implanted with EVAR and parallel thrombogenic fibers embolization of the aneurysm sac.
The company stated that in the study group at 24-month follow-up after implantation, the investigators found a dramatic improvement of freedom from endoleaks and secondary interventions and the reduction of the aneurysm volume and diameter.
Additionally, they observed no complications related to thrombogenic fibers embolization, a significantly reduced rate of secondary operations and endoleaks in the study group from 78% to 47% (P = .003), and a significant reduction of aneurysm volume of approximately 55% in patients in the study group versus the control group at 24 months (P = .001).
In Affluent Medical's announcement, Prof. Fabre commented, “This is a long-awaited clinical improvement in EVAR outcomes that can be standardized in a ready to use thrombogenic fibers coated prosthesis providing the same functional embolization as in the SCOPE 1 study.”