VenoStent is conducting a 200-subject, prospective, one-to-one randomized controlled trial in dialysis access
HOUSTON, TX / ACCESSWIRE / January 30, 2024 / VenoStent, Inc., a clinical-stage, venture-backed, therapeutic medical device company developing bioabsorbable wraps to improve outcomes for hemodialysis patients, has announced enrollment of its first subjects in its SAVE-FistulaS Clinical Trial at the Surgical Specialists of Charlotte, P.A. in Charlotte, NC, and the Cardiothoracic and Vascular Surgeons in Austin, Texas.
US Clinical Trial
"This is the first ever randomized controlled trial (RCT) in the United States involving a medical device to improve outcomes from arteriovenous fistula (AVF) creation surgery," explains Timothy Boire, PhD, CEO and cofounder, VenoStent. "While it's ambitious and sets a high bar for FDA Approval, we owe it to the chronic kidney disease (CKD) patient community to provide the highest level of clinical evidence. We're confident based on years of preclinical and clinical data that we'll demonstrate superiority to standard of care with this Breakthrough Technology."
In May 2023, VenoStent's SelfWrap Bioabsorbable Perivascular Wrap (i.e. SelfWrap) was approved by the FDA to begin its US IDE Study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistula Study. The Company is conducting a 200-subject, prospective, 1:1 RCT, considered the gold standard in clinical trial design, enrolling subjects for both radiocephalic and brachiocephalic fistulas with the idea that its technology can be applied for nearly all AVFs. There are nearly 500,000 people in the US relying on hemodialysis to survive and almost all undergo at least one vascular access creation surgery - a procedure that has a greater than 50% one-year failure rate.
VenoStent enrolls its first patient into a first-of-its-kind, 200-subject clinical trial to improve outcomes from arteriovenous fistula creation surgery. From the left: VenoStent Director of Clinical Affairs Mark Barakat, MD; Project Coordinator Hala Barakat; Surgeon Jason Burgess, MD; and VenoStent Co-Founders, CEO Tim Boire, PhD, and COO Geoffrey Lucks.
"I'm thrilled that the company has progressed to this stage. I applaud them for doing an RCT with Level A clinical evidence in mind, as this will be essential to convince physicians of its utility if and when it attains FDA Approval," said Dr. Eric Peden, Chief of Vascular Surgery at Houston Methodist Hospital in Houston, Texas and the National Principal Investigator (PI) of the SAVE-FistulaS clinical trial that has collaborated with VenoStent since 2018 on National Institute of Health (NIH)- and National Science Foundation (NSF)-funded studied.
"We're proud to be the first site to enroll a patient in the study, as we believe that this technology can make a real difference in the lives of hemodialysis patients," added Dr. Jason Burgess, PI at the Surgical Specialists of Charlotte.
VenoStent COO and cofounder, Geoffrey Lucks, explains how the SelfWrap procedure works: "We're using the body's own healing mechanisms to our advantage by mimicking the arterial environment in veins. When a vein is connected to an artery, as in AVF creation, the vein experiences a 10x increase in pressure and flow that is traumatizing to veins. Many fail to become usable for dialysis. Our technology bridges that gap to help ‘arterialize' the vein, and then is slowly resorbed and replaced by venous tissue. This is a complicated problem we aim to resolve with an elegant solution - mimic the arterial environment until you don't have to anymore."
"We're working with superb collaborators in hospitals and research organizations across the US, using the best science, and are tackling a true unmet clinical need. As a clinical trialist for more than two decades, usually you don't get all of the above," adds Dr. Mark Barakat, VenoStent's Director of Clinical Affairs.
About VenoStent
VenoStent, Inc. (www.venostent.com) is a privately held, therapeutic medical device company developing a bioabsorbable wrap, SelfWrap, to transform outcomes in vascular surgery, starting with hemodialysis access. The Company recently completed a $16M Series A financing led by Good Growth Capital and IAG Capital to support this clinical trial as well as operations towards FDA Approval and commercialization.
Forward-Looking Statements
Some of these statements are forward-looking and the product discussed is in the investigational stage. It is not available for sale in the US nor worldwide.
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SOURCE: VenoStent