Sam Brusco, Associate Editor05.19.22
VenoStent, a clinical-stage tissue engineering firm developing bioabsorbable perivascular wraps to improve vascular surgery outcomes, as earned breakthrough status from the U.S. Food and Drug Administration (FDA) for its SelfWrap bioabsorbable perivascular wrap.
"We are very honored that the FDA recognizes the promise of VenoStent's SelfWrap technology to improve the quality and length of life of chronic kidney disease (CKD) patients that require hemodialysis treatments, a life-threatening condition that can be devastating for patients" VenoStent CEO Tim Boire told the press. "About a year ago, we embarked on a clinical trial to assess the safety and effectiveness of our novel tissue engineering technology to help CKD patients needing dialysis, and the results of this study are highly encouraging, in terms of both safety and effectiveness. This Breakthrough Device Designation is an acknowledgement from the FDA that VenoStent's SelfWrap has established ‘a reasonable expectation of technical and clinical success' with these clinical results and is indeed a promising potential solution for CKD patients. We look forward to all of the benefits that are afforded by this designation, and the potentially profound impact that our device can have on this patient population, as well as others in the future."
VenoStent’s SelfWrap is a macroporous, bioabsorbable polymer wrap that provides scaffolding for vein grafting, helping them arterialize.
"This is a major step towards helping chronic kidney disease patients in the United States. We are grateful to the team at FDA, our own team, and all of those who have backed us over the years," said Boire.
"We are very honored that the FDA recognizes the promise of VenoStent's SelfWrap technology to improve the quality and length of life of chronic kidney disease (CKD) patients that require hemodialysis treatments, a life-threatening condition that can be devastating for patients" VenoStent CEO Tim Boire told the press. "About a year ago, we embarked on a clinical trial to assess the safety and effectiveness of our novel tissue engineering technology to help CKD patients needing dialysis, and the results of this study are highly encouraging, in terms of both safety and effectiveness. This Breakthrough Device Designation is an acknowledgement from the FDA that VenoStent's SelfWrap has established ‘a reasonable expectation of technical and clinical success' with these clinical results and is indeed a promising potential solution for CKD patients. We look forward to all of the benefits that are afforded by this designation, and the potentially profound impact that our device can have on this patient population, as well as others in the future."
VenoStent’s SelfWrap is a macroporous, bioabsorbable polymer wrap that provides scaffolding for vein grafting, helping them arterialize.
"This is a major step towards helping chronic kidney disease patients in the United States. We are grateful to the team at FDA, our own team, and all of those who have backed us over the years," said Boire.