Medtech startup Affluent Medical (Paris, France) said a study of its endovascular aneurysm repair (EVAR) system device showed patients had fewer endoleaks and needed fewer secondary interventions, and that their aneurysms shrank in volume and diameter.
The company’s Kardiozis endovascular prosthesis uses thrombogenic fibers to embolize an abdominal aortic aneurism sac during a conventional EVAR procedure to prevent endoleaks and the recurrence of the condition.
The Scope 1 randomized, controlled, multicentric clinical trial enrolled 102 patients at four sites in France, beginning in 2013. With a 24-month follow-up after implant, the study group of 46 patients had an endoleak rate of 47% compared with 78% for the control group. Aneurysm volume was reduced by about 55%, and no complications related to thrombogenic fibers embolization were observed, the company said.
Principal investigator Dominique Fabre, M.D., presented the results at the recent Controversies And Updates in Vascular Surgery congress in Paris.
“This is a long-awaited clinical improvement in EVAR outcome that can be standardized in a ready-to-use thrombogenic fiber-coated prosthesis providing the same functional embolization as in the SCOPE 1 study,” Fabre said in a prepared statement.
The Kardiozis technology can be applied both to existing endoprostheses on the market via corporate partnerships and to Affluent’s own endoprosthesis, which is under development, according to Affluent Medical CEO Daniele Zanotti. The company intends to launch Kardiozis in Europe by 2021.