Affluent Medical, a French medtech company specialized in innovative, minimally invasive implants designed to restore key physiological functions for patients suffering from heart and vascular diseases, as well as urinary incontinence, today announces positive results from its SCOPE 1 clinical trial validating the efficacy of KARDIOZIS technology.
Results have been presented Saturday February 9th, 2019 at Controversies And Updates in Vascular Surgery congress (CACVS) in Paris by Professor Dominique Fabre, MD, principal investigator. Study contributors are Frederic Cochennec, MD, Claude Angel, MD, Eric Allaire, MD, Philippe Brenot, MD, Riyad Bourkaib MD, Jean-Yves Riou, MD, Pascal Desgranges, MD, Benoit Gerardin, MD, Delphine Mitilian MD, Carlos Garcia Alonzo, MD, Sarah Hamdi, MD, Jean-Pierre Becquemin, MD, and Professor Stephan Haulon, MD.
SCOPE 1 clinical trial started in 2013 under the lead of Professor Dominique Fabre, thoracic and vascular surgeon at MARIE LANNELONGUE hospital РLe Plessis-Robinson (France), in collaboration with PARIS-SUD SACLAY University (France), and with the participation of Frederic Cochennec, vascular surgeon at HENRI MONDOR hospital – Creteil (France), in collaboration with PARIS-EST University (France).
SCOPE 1 is a controlled, randomized, prospective, multi-centric clinical trial at evaluating efficacy and clinical outcomes of embolization of the aneurysm sac using thrombogenic fibers when performing a conventional EndoVascular Aneurysm Repair (EVAR).
102 patients have been enrolled, in two arms: 91 patients data records were analyzed:
– 45 patients in the Control group: patients implanted with EVAR only;
– 46 patients in Study group: patients implanted with EVAR and parallel thrombogenic fibers embolization of the aneurysm sac.
With a 24-month follow-up after implant, the Study group of patients has shown a dramatic improvement of the freedom from endoleaks and secondary interventions, and the reduction of the aneurysm volume and diameter.
– No complications related to thrombogenic fibers embolization were observed.
– Rate of secondary operations and endoleaks was significantly reduced in the Study Group (p= 0.003) from 78% to 47%.
– A significant reduction of aneurysm volume of about 55% was observed in patients in the Study Group Vs the Control Group at 24 months (p=0.001).
Professor Dominique Fabre, indicates:
“This is a long-awaited clinical improvement in EVAR outcome that can be standardized in a ready to use thrombogenic fibers coated prosthesis providing the same functional embolization as in the SCOPE 1 study.”
Daniele Zanotti, CEO of AFFLUENT MEDICAL said:
“KARDIOZIS proprietary technology has been conceived to achieve the same results but avoiding the complexity of an additional procedure, by effectively preventing type II endoleaks which is the main complication after an EVAR implant. This trial confirms, with strong evidence, the therapeutic value of the KARDIOZIS technology, which has the potential of achieving far superior clinical outcomes, reduced need for reintervention and fewer control visits.
KARDIOZIS technology, proven in the SCOPE 1 trial, can be applied both to existing endoprosthesis on the market, via corporate partnerships, and to Affluent own endoprosthesis under development. We thank Prof. Fabre and the whole team of investigators which has conducted the SCOPE 1 trial to this spectacular result.”
