Prospective Study Shares Early Clinical Experience with Shape Memory Polymer Vascular Plugs for Pelvic Venous Disease
2024年5月13日 - 3:00PM
ビジネスワイヤ(英語)
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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240512199289/en/
Vascular Surgery and Interventional
Radiology Unit and Department of Gynecology and Obstetrics, Clínica
Universidad de Navarra, Madrid, Spain (Photo: Business Wire)
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240512199289/en/
Shape Memory Medical Inc. Mary Dennehy
m.dennehy@shapemem.com