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Shape Memory Medical – RoW

Clinical & Preclinical

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PUBLICATIONS
CLINICAL REGISTRIES & STUDIES
CASE STUDIES

Publications

Leal-PVD-2024

Early Experience on Embolisation of Female Pelvic Venous Disease With a Single Shape Memory Vascular Plug: A Prospective Magnetic Resonance Imaging Based Evaluation

José Ignacio Leal Lorenzo, Jose María Hípola Ullecia, Eugenia Pillado Rodríguez, Regina Cárdenas Santos, and Alberto Alonso Burgos

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2023 SMP Publication_Holden

Shape memory polymer technology in peripheral vascular embolization

Andrew Holden, Andrew Hill, and Brendan T Buckley

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Echeverria_TrelliX Embolic Coil_ Intracranial Aneurysm embolization_Chile_JNIS 2022_Page_1

A novel self-expanding shape memory polymer coil for intracranial aneurysm embolization: 1-year follow-up in Chile
Daniel Echeverría, Rodrigo Rivera, Pablo Giacaman, Juan Gabriel Sordo, Martín Einersen, Lautaro Badilla

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Peripheral embolization, CVIR Endovascular publication

Shape memory polymer ovarian vein embolisation in a patient with nickel allergy
Davide Castellano, Andrea Boghi, Luca Di Maggio, Alessandro Rapellino and Daniele Savio

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Peripheral embolization, CVIR Endovascular publication

Clinical experience with a shape memory polymer peripheral vascular embolization plug: a case series
Robert A. Morgan, Ian Loftus, Lakshmi Ratnam, Raj Das, Leto Mailli, Mohamad S. Hamady and Kyriakos Lobotesis

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Publications (Preclinical)

Preclinical publication

Macrophage activation in response to shape memory polymer foam-coated aneurysm occlusion devices
Sarah M. Chau, Scott M. Herting, Dillon A. Noltensmeyer, Hamzah Ahmed, Duncan J. Maitland, and Shreya Raghavan

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Preclinical publication

Microscopic Assessment of Healing and Effectiveness of a Foam- Based Peripheral Occlusion Device
Staci L. Jessen, Molly C. Friedemann, Anne-Marie Ginn-Hedman, Lance M. Graul, Steven Jokerst, Cedric B. Robinson, Todd L. Landsman, Fred J. Clubb, Jr., and Duncan J. Maitland

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Peripheral embolization preclinical publication

TCT-286 Novel Approach for Treatment of Aortic Stent Graft Endoleak: A Preclinical Feasibility Study of Catheter-Delivered Expandable Foam
Gilberto Melnick, Marco Ferrone, Nicolas Isaza, Genghua Yi, Yanping Cheng, Jeffrey Carpenter, Duncan Maitland, Todd Landsman, Juan Granada, and Grzegorz Kaluza

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Preclinical publication

In vitro cytocompatibility testing of oxidative degradation products
Scott M Herting, Mary Beth B Monroe, Andrew C Weems, Sam T Briggs, Grace K Fletcher, Samuel E Blair, Christopher J Hatch, and Duncan J Maitland

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Preclinical publication

Shape Memory Polymer Foams Synthesized Using Glycerol and Hexanetriol for Enhanced Degradation Resistance
Sayyeda Marziya Hasan, Grace K. Fletcher, Mary Beth Browning Monroe, Mark A. Wierzbicki, Landon D. Nash, Duncan J. Maitland

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Preclinical publication

In vivo comparison of shape memory polymer foam-coated and bare metal coils for aneurysm occlusion in the rabbit elastase model
Scott M. Herting, Yonghong Ding, Anthony J. Boyle, Daying Dai, Landon D. Nash, Solmaz Asnafi, Daniel R. Jakaitis, Collin R. Johnson, Lance M. Graul, Chung Yeh, David F. Kallmes, Ramanathan Kadirvel, Duncan J. Maitland

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Preclinical publication

Multifunctional Shape-Memory Polymer Foams with Bio-inspired Antimicrobials
Mary Beth Browning Monroe, Alexandra D. Easley, Katie Grant, Grace K. Fletcher, Calla Boyer, Duncan J. Maitland

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Preclinical publication

Opacification of shape memory polymer foam designed for treatment of intracranial aneurysms
Jennifer N. Rodriguez, Ya-Jen Yu, Matthew W. Miller, Thomas S. Wilson, Jonathan Hartman, Fred J. Clubb, Brandon Gentry, Duncan J. Maitland

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Preclinical publication

Micro-CT and histopathology methods to assess host response of aneurysms treated with shape memory polymer foam-coated coils versus bare metal coil occlusion devices
Staci L. Jessen, Molly C. Friedemann, Annmarie E. Mullen, Anne-Marie Ginn-Hedman, Scott M. Herting, Duncan J. Maitland, Fred J. Clubb Jr

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Preclinical publication

Comparison of shape memory polymer foam versus bare metal coil treatments in an in vivo porcine sidewall aneurysm model
John Horn, Wonjun Hwang, Staci L. Jessen, Brandis K. Keller, Matthew W. Miller, Egemen Tuzun, Jonathan Hartman, Fred J. Clubb, Jr., Duncan J. Maitland

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Preclinical publication

Reticulation of low density shape memory polymer foam with an in vivo demonstration of vascular occlusion
Jennifer N Rodriguez, Matthew W. Miller, Anthony Boyle, John Horn, Cheng-Kang Yang, Thomas S. Wilson, Jason M. Ortega, Ward Small, Landon Nash, Hunter Skoog, Duncan J. Maitland

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Clinical Registries & Studies

IMPEDE and IMPEDE-FX Embolization Plug Post-Market Surveillance (EMBO-PMS)

EMBO-PMS is a prospective, multicentre, post-market surveillance study of the IMPEDE and IMPEDE-FX Embolization Plug System.

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Aneurysm Packing With the Expandable TrelliX Coil System – A Prospective Safety Study (APEX-FIH)

APEX-FIH is a first-in-human, open-label prospective multicenter study of the TrelliX Embolic Coil System for use in embolization of the medium to large, ruptured or unruptured cerebral aneurysms.

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Case Studies

LIT1106 Rev A – Case Study – Ovarian Vein Embo – Knusel

IMPEDE® Embolization Plug family for ovarian vein embolization
Kantonsspital Graubünden, Chur, Switzerland – Patrick Knüsel, MD

“The completion angiogram showed complete embolization.”

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LIT1107 Rev A – Case Study – Splenomegaly – Morgan

IMPEDE® Embolization Plug family for treatment of splenomegaly
St George’s University Hospitals, London, United Kingdom – Robert Morgan, MD

“The splenectomy was performed 2 days later, as planned.”

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LIT1105 Rev A – Case Study – IMP and IMP-FX- IMA and RAA – Massman

IMPEDE® and IMPEDE-FX Embolization Plugs for inferior mesenteric artery and left renal accessory artery embolization embolization
Saarland University Medical Center, Homburg/Saar, Germany – Alexander Massmann, MD, PhD

“Devices remained stable upon deployment.”

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LIT1103 Rev A – Case Study – IMPEDE – Iliac Artery Embo – van den Berg

IMPEDE® Embolization Plug for iliac artery aneurysm embolization
Lugano University Hospital, Lugano, Switzerland – Jos C. van den Berg, MD, PhD

“…complete embolization achieved after ten minutes.”

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LIT1104 Rev A – Case Study – IMPEDE Iliac Artery Aneurysm 2 – Morgan

IMPEDE® Embolization Plug for treatment of right common iliac artery aneurysms
St George’s University Hospitals, London, United Kingdom – Robert Morgan, MD

“Acute vessel embolization was achieved.”

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LIT1102 Rev A – Case Study – IMPEDE – Gluteal artery – Morgan

IMPEDE® Embolization Plug for the treatment of a left inferior gluteal artery aneurysm
St George’s University Hospitals, London, United Kingdom – Robert Morgan, MD

“Acute vessel embolization was achieved.”

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LIT1101 Rev A – Case Study – IMPEDE Type II EL Toracic aorta – Morgan

IMPEDE® Embolization Plugs to treat a type II endoleak into the thoracic aorta
St George’s University Hospitals, London, United Kingdom – Robert Morgan, MD

“…confirmed continued vessel occlusion and no further endoleak…”

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LIT1100 Rev A – Case Study – IMPEDE R Common Iliac – Morgan

IMPEDE® Embolization Plug for the treatment of right common iliac artery aneurysms
St George’s University Hospitals, London, United Kingdom – Robert Morgan, MD

“…vessel remained occluded…aneurysm size is stable.”

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LIT1108 Rev A – Case Study – TrelliX – Bilateral Carotid Cavernous Fistula – Luttich

TrelliX® Embolic Coil for bilateral carotid cavernous fistula
Hospital Universitario Donostia, San Sebastián, Spain – Àlex Lüttich MD, EBNR

“There was no need to use any additional embolization agents.”

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Neurovascular embolization case study

TrelliX® Embolic Coils for Post Traumatic Direct CCF
Odense University Hospital, Odense Denmark – Guyla Gál, MD

“Complete CCF occlusion with such low packing density would not have been possible with traditional embolic coils. The TrelliX Embolic Coils made the difference.”

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Neurovascular embolization case study

TrelliX® Embolic Coils for Post Traumatic Direct CCF
Odense University Hospital, Odense Denmark – Guyla Gál, MD

“Complete CCF occlusion with such low packing density would not have been possible with traditional embolic coils. The TrelliX Embolic Coils made the difference.”

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Neurovascular embolization case study

TrelliX® Embolic Coils for Malignant AV Fistula
Odense University Hospital, Odense Denmark – Guyla Gál, MD

“Complete AVF occlusion with TrelliX Embolic Coils was achieved with fewer number of devices than expected.”

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Neurovascular embolization case study

TrelliX® Embolic Coils for Pericallosal Artery Aneurysm
Odense University Hospital, Odense Denmark – Guyla Gál, MD

Treatment of a wide-neck aneurysm with the TrelliX Embolic Coil could be completed without the use of adjunctive devices. Angiography confirmed embolization due to the expanding shape memory polymer. Imaging clarity enabled visibility through the coil mass and surrounding anatomy.

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Neurovascular embolization case study

TrelliX® Embolic Coils for Elective Treatment of an Azygos Pericallosal Artery Aneurysm
Odense University Hospital, Odense Denmark – Guyla Gál, MD

Azygos pericallosal artery is a rare anatomic variation, when the first segment of the artery is common for both sides. Since this vessel supplies both distal segments of the right and left pericallosal arteries, it is not uncommon to see the aneurysm developing at the bifurcation, due to the high flow.

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Neurovascular embolization case study

TrelliX® Embolic Coils
Large Basilar Tip Aneurysm

Odense University Hospital, Odense Denmark – Guyla Gál, MD

“Progressive occlusion was evident from time 0 to follow-up. Parent vessels at bifurcation remained patent.”

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