VenoStent’s SelfWrap Perivascular Wrap Designated a Breakthrough Device

VenoStent’s SelfWrap bioabsorbable perivascular wrap has been designated a Breakthrough Device by the FDA.

SelfWrap is intended to improve the quality and length of life of chronic kidney disease (CKD) patients who require hemodialysis.

Many CKD patients need vein grafting surgery but the surgeries have extremely high failure rates. The SelfWrap device is a bioabsorbable polymer wrap that provides scaffolding for the grafted veins, helping them to “arterialize.”

VenoStent launched a clinical trial last year to assess the novel tissue-engineering technology for CKD patients needing dialysis. The results from the study “are highly encouraging in terms of both safety and effectiveness,” the company said.