The Fix8 non-migrating stent platform overcomes the limitations of current surgical stents for procedures having a short landing zone and addresses the complications associated with stent migration and occlusion. Fix8’s secure anchoring hook deployment system keeps the device in place, resulting in improved surgical success rates, decreased need for additional procedures and reduced overall health care costs.
Gastro-intestinal surgeries feature a high incidence of anastomotic biliary enteric (~10%), colorectal (22-30%) and ureter/ileal conduit (~14%) post-operative strictures, which require surgically implanting stents to correct. These common surgical complications are debilitating, often requiring prolonged hospital stays and repeated or corrective procedures.
While current stents are designed to keep strictures open, they are subject to migrating out of place due to the short landing zone or clogging. In addition to potentially harming patients, stent migration and clogging require additional surgeries to remove and replace stents, which increases health care costs and affects readmission rates.
Researchers at Wake Forest School of Medicine have developed Fix8, a non-migrating stent platform for treating strictures. Instead of the typical self-expanding deployment, the device features two sets of anchoring hooks. The hooks are deployed separately at either end of the stent using balloon dilation, resulting in precise and secure placement in the desired location. The hooks are designed with a specific shape and stiffness to achieve maximum security. The open design prevents clogging associated with hard plastic stents.
- Prevents stent migration or clogging
- Ensures precise stent placement
- Eliminates need for external drains
- Improves patient safety and outcomes
- Decreases need for additional procedures/patient readmission
Clifford Howard Jr., MD, Department of Radiology
Philip Brown, PhD, Department of Biomedical Engineering
Surgical anastomotic strictures, liver transplantation, colorectal surgery, biliary surgery, ureteral diversion, pancreatic duct surgery, bariatric surgery
Stage of Development
Prototype development, bench testing and testing in preclinical models are underway.
PCT Patent Application Serial No. PCT/US2017/19389
Stricturoplasty, long term drain catheter, endoluminal colonic wall stent, biliary enteric strictures, ileal conduit strictures, stent migration, non-migrating stent
John Druga, MS, MBA
Licensing Director, Center for Technology Innovation & Commercialization
Ref #: WFU 14-44