SARASOTA (March 20, 2025) - Sarasota Memorial Hospital is among 10 research sites studying an investigational device designed to reduce the risk of bleeding complications in patients undergoing hemodialysis treatment.
Led by vascular surgeon Inky Parrack, MD, Sarasota Memorial’s research and operative team is participating in a clinical study evaluating Gore’s InnAVasc immediate-usage graft. The study is evaluating the benefits of InnAVasc’s multi-layered construction and self-sealing puncture zone designed to allow immediate use after implantation in patients undergoing hemodialysis.
“With over 2 million people worldwide relying on dialysis for life-saving treatment, innovations are essential for improving patient safety, comfort, and quality of life,” said the Sarasota Memorial study principal investigator Inky Parrack, MD, FACS, RPVI.
A typical patient undergoes dialysis three times per week, with over 300 needle insertions per year. Unlike traditional grafts, the investigational InnAVasc device is designed with a protective backplate to protect patients from accidental needle punctures. In addition to its protective backplate, the research device offers raised target zones designed to make it easier for medical professionals to safely access the cannulation area, as well as self-sealing pods to close the puncture sites, which may minimize pain, swelling, and bruising.
Enrollment in the trial is ongoing. Since November 2024, the SMH team has successfully implanted three InnAVasc grafts. While most grafts require a waiting period of 2-4 weeks before use, the InnAVasc device allows patients to begin hemodialysis immediately after implantation.
Dialysis is a treatment for people with kidney failure, or end-stage renal disease, whose kidneys are no longer able to filter toxins and waste from your bloodstream. During hemodialysis, a dialysis machine is used to remove blood from your arm and pass it through a special filter before returning the cleaned blood back to your bloodstream. Before starting treatment, most patients must undergo a surgical procedure and receive a graft to stabilize and enlarge the connected artery and vein and make dialysis access easier.
W. L. Gore & Associates, Inc., a global material science company, acquired InnAVasc Medical and the investigational device in 2022, and is sponsoring the ongoing study focused on advancing care for patients with end stage renal disease. INNAVASC is a trademark of InnAVasc Medical, Inc., a wholly owned subsidiary of W. L. Gore & Associates, Inc.
Caution– Investigational device, limited by United States law to investigational use.
About the Sarasota Memorial Research Institute
Sarasota Memorial Research Institute (SMRI) provides advanced research services and a highly qualified staff that advances the latest treatment options for patients in our community. Located on Sarasota Memorial Health Care System’s Sarasota campus, the Institute provides the knowledge, expertise, and infrastructure essential to evaluate and manage innovative drug, device, registry, and biospecimen clinical trials across a wide spectrum of disease processes, including cardiology, infectious disease, gastroenterology, neurology, oncology, pulmonology, urology, vascular, and more. For information about clinical studies or participating in clinical trials, contact the Sarasota Memorial Research Institute at (941) 917-2225.