Prospective Study Shares Early Clinical Experience with Shape Memory Polymer Vascular Plugs for Pelvic Venous Disease

The IMPEDE Embolization Plug family contains proprietary shape memory polymer technology, which is a low-density, porous embolic material that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organized thrombus. 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.

Chronic pelvic pain (CPP) can affect both women and men. Of those patients with CPP, many have pain caused by PVD. Endovascular embolization to treat PVD is a well- established practice, however, given the young age of the affected population, unresolved concerns can arise when treating with permanent alloy or metal implants. In this prospective, observational case series, Jose Ignacio Leal Lorenzo, MD, PhD, and lead author, reports encouraging outcomes in this early experience. “All 5 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 Dr. Leal. “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.

All patients were evaluated by a multidisciplinary team including complete gynecological assessment to exclude other causes of pelvic pain. “Treating these patients in the hybrid operating room with the same team across integrated departments ensured consistency of the procedure and treatment,” explained Alberto Alonso Burgos, MD, PhD, interventional radiologist and co-author. Regina Cárdenas Santos, MD, gynecologist and co-author reiterated, “This further demonstrates how building relationships and collaboration between different specialties improves women’s health.”

“We understand there are challenges diagnosing patients with PVD, as they come through various referral pathways,” said Ted Ruppel, President and CEO of Shape Memory Medical. “We appreciate the work that was done in Madrid with collaboration from both the Vascular Surgery and Interventional Radiology Unit along with the Department of Gynecology and Obstetrics to publish this first of its kind prospective study,” Ruppel explained.

Early Experience on Embolisation of Female Pelvic Venous Disease With a Single Shape Memory Vascular Plug: A Prospective Magnetic Resonance Imaging Based Evaluation, published by Leal et al, is available via open access at https://authors.elsevier.com/a/1iutJ3rFXltnme. For more information about Shape Memory Polymer for Pelvic Venous Disorders, visit www.shapemem.com/pelvic-health.