The clinical evaluation forms part of Tissue Regenix’s ongoing development plan for the device.
21 patients, aged between 47 and 78 at the time of surgery received dCELL Vascular Patch at the beginning of the study.
The patch was reported to have performed well, with significantly improved blood flow in all but one case.
Therefore, 94% of patients that were assessed at 12 months post surgery did not report a worsening of symptoms or a return of the original blockage.
The dCELL Vascular Patch also demonstrated shorter suture hole bleed times compared with other synthetic patches.
Patients will continue to be monitored by their doctors for another year, at which time the study is scheduled to finish.
Tissue Regenix MD Antony Odell said dCELL Vascular Patch also has lower frequency of infection and a quicker time to stop bleeding post procedure compared to some of the other synthetic products currently available.
Tissue Regenix aims to continue to use dCELL Technology as a platform to develop a range of products using the established medical device regulatory pathway to deliver solutions to unmet clinical needs.
