Study Examines Use of Shape-Memory Polymer to Treat Pelvic Venous Disease

A developer of custom shape-memory polymers for endovascular markets, Shape Memory Medical Inc. has announced the publication of a prospective observational study looking at the use of a single shape-memory polymer plug, the Impede-FX Embolization Plug, to treat female pelvic venous disease (PVD).

PVD is caused by malfunctioning valves in the veins of the pelvis and around the uterus, resulting in blood pooling in those areas. The condition is similar to varicose veins in the legs.

Chronic pelvic pain (CPP) can affect both women and men, and many of them may experience pain caused by PVD. Endovascular embolization to treat PVD is a well-established practice. Although conventional techniques are deemed safe and effective, concerns regarding permanent implants, such as coils or nitinol plugs, in a very young population are still unresolved, write the researchers.

The five patients followed in this study "returned to their daily activities the day after their procedures and showed a decrease in their scores associated with pain at 30-day follow-up,” said lead author Jose Ignacio Leal Lorenzo, MD, PhD. “This novel approach, using a single shape-memory polymer plug, has the potential advantage to reduce the metal left behind without impacting efficacy,” continued Dr. Leal. 

The Impede Embolization Plug family contains proprietary shape-memory polymer technology. The low-density, porous embolic material is crimped for catheter delivery and self-expands upon contact with blood. The technology offers unique properties that could be beneficial in patients suffering from chronic pelvic pain, including vascular space-filling, soft and conformable material, and radiolucency for enhanced imaging visibility and minimal artifact.

The prospective study was published in the European Journal of Vascular and Endovascular Surgery by Leal et al., and the work was conducted by the Department of Vascular Surgery and Interventional Radiology and the Department of Gynecology and Obstetrics at Clínica Universidad de Navarra in Madrid.