France-based medtech company Affluent Medical has announced positive results from its SCOPE 1 clinical trial validating the efficacy of Kardiozis technology: an endoprosthesis using thrombogenic fibre embolisation of the aneurysm sac to prevent endoleak and reintervention.
The results were presented at the Controversies And Updates in Vascular Surgery congress (CACVS; 7–9 February, Paris, France) by principal investigator Dominique Fabre. Study contributors include Frederic Cochennec, Claude Angel, Eric Allaire, Philippe Brenot, Riyad Bourkaib Jean-Yves Riou, Pascal Desgranges, Benoit Gerardin, Delphine Mitilian, Carlos Garcia Alonzo, Sarah Hamdi, Jean-Pierre Becquemin and Stéphan Haulon.
The SCOPE 1 clinical trial began in 2013 under the lead of Dominique Fabre, thoracic and vascular surgeon at Marie Lannelongue hospital (Le Plessis-Robinson, France), in collaboration with Paris-Sud Saclay University and with the participation of Frederic Cochennec (Henri Mondor hospital, Creteil, France), in collaboration with Paris-Est University, France.
SCOPE 1 is a controlled, randomised, prospective, multicentre clinical trial designed to evaluate efficacy and clinical outcomes of embolisation of the aneurysm sac using thrombogenic fibres when performing a conventional endovascular aneurysm repair (EVAR).
One hundred and two patients have been enrolled, and 91 patients’ data records analysed. In the control group, 45 patients were implanted with a standard EVAR device only. Forty-six patients in study group received EVAR and parallel thrombogenic fibre embolisation of the aneurysm sac.
With a 24-month follow-up post-procedure, patients in the study group have reportedly 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 fibres embolisation were observed. The rate of secondary operations and endoleaks was significantly reduced in the study group from 78% to 47% (p=0.003). A significant reduction of aneurysm volume of about 55% was observed in patients in the study group as compared to the control group at 24 months (p=0.001).
“This is a long-awaited clinical improvement in EVAR outcome that can be standardised in a ready-to-use thrombogenic fibres coated prosthesis providing the same functional embolisation as in the SCOPE 1 study,” Dominique Fabre says.
Daniele Zanotti, CEO of Affluent Medical, comments, “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.” Zanotti adds that the technology can be applied “both to existing endoprosthesis on the market, via corporate partnerships, and to Affluent’s own endoprosthesis under development.”