SAN JOSE, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the publication of a prospective observational study looking at the use of a single shape memory polymer plug, the IMPEDE-FX Embolization Plug, as the embolization agent to treat female pelvic venous disease (PVD). Published in the European Journal of Vascular and Endovascular Surgery by Leal et al, this 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, Spain.
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.
About Shape Memory Medical
Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers, with devices approved in more than 25 countries spanning regions in Asia, the Middle East, Europe, the Americas and Australia. Neurovascular embolization products include the TrelliX® Embolic Coil, which is CE marked for use in the EU. Peripheral embolization products include the IMPEDE® and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill® Device. In countries recognizing CE marking, the IMPEDE and IMPEDE-FX Embolization Plugs and the IMPEDE-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature, and the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE and IMPEDE-FX Embolization Plugs are PMDA approved in Japan. The IMPEDE-FX RapidFill Device is not available in the United States or Japan. For more information, visit www.shapemem.com.
