Xeltis announces positive preliminary results of restorative hemodialysis access graft
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Xeltis announced the clinical trial of the restorative hemodialysis access graft, aXess, showed promising early puncturing, patency and safety data, according to a press release.
As Healio previously reported, the aXess graft is designed to restore living blood vessels using patients’ tissue. The aXess graft has been implanted in 11 patients so far, all of which had a median follow-up of 6.5 months. Preliminary data from the clinical trial show full functional patency and safety, in addition to ease of use for surgeons and dialysis nurses.
“Our first clinical experience using the aXess device is extremely encouraging. This fully synthetic graft is easy to implant, can be promptly punctured and exhibits an excellent safety profile,” Matteo Tozzi, MD, vascular surgeon and professor of vascular surgery at Università dell’Insubria in Italy, said in the press release. “Its potential to turn into a longer-lasting natural vessel is an additional benefit and suggests that an optimal solution for dialysis patients may be within our reach.”
More than 600 dialysis sessions have taken place in the 11 patients implanted with aXess, with some dialysis initiation starting as early as 2 weeks after implantation.
“At a time when fistula is being challenged as a first-line treatment in a number of dialysis patients, the first-ever clinical data for aXess are particularly significant and aligned with its remarkable and unprecedented positive results from preclinical trials, showing its full endothelialization,” Frans L. Moll, MD, PhD, professor emeritus of vascular surgery at the University Medical Center Utrecht in The Netherlands, said in the release.
Tozzi and Moll plan to share more data at the Charing Cross International Symposium on Vascular and Endovascular Challenges 2022 in London.
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