Clinical experience with a shape memory polymer peripheral vascular embolisation plug: a case series

Abstract

Background Shape memory polymers are materials that are manufactured in a certain shape, can be stored in a temporary deformed shape, and then return to – or remember – their original shape upon exposure to external stimuli such as temperature and moisture. This property lends itself to application in endovascular medical devices. Peripheral vasculature embolisation devices incorporating this novel technology have become commercially available and this case series, where the data were collected as part of a post market registry, outlines initial clinical experience with these novel devices. Results Eight cases are described in this series. The disease state/conditions for which embolisation was indicated were right common iliac artery aneurysms (n = 3), a type II endoleak into the thoracic aorta following thoracic endovascular aneurysm repair (n = 1), a left inferior gluteal artery aneurysm (n = 1), left internal iliac artery aneurysms (n = 2), and a case of splenomegaly, where splenectomy was planned after the embolisation procedure (n = 1). Target arteries were 5–10 mm in diameter. In each case, at least one IMPEDE Embolization Plug (IMP-Device) of an appropriate diameter was used. All procedures were technically successful and target vessel thrombosis was achieved in all cases. Follow-up imaging available during the 45–90-day data collection timeframe showed sustained vessel occlusion. This case series includes examples of situations commonly encountered when embolising the peripheral vasculature, namely, the use of one or multiple devices in a single vessel and in combination with the use of other embolic devices (e.g., microcoils, gelatin sponge, and PVA particles) in the same case. There were no adverse events related to the specific use of the device. Conclusions This small series illustrates the safety and efficacy of this novel sponge-based embolic device for the embolisation of small and medium sized arteries and further experience will demonstrate the utility of the shape memory polymer devices.

The Current Status, Prospects, and Challenges of Shape Memory Polymers Application in Bone Tissue Engineering

“…Therefore, a great deal of work on the biomedical applications of PCL (SMPs) is trying to increase their toughness and SME by blending with other polymers, just as PCL optimizes its properties by combining with poly(propylene carbonate) (PPC), 1,2,4-triazoline-3,5-dione (TAD), and PLLA [ 25 , 26 , 27 ]. In recent years, with the continuous progress of biochemical materials research and development technology and due to the high availability and minimized invasiveness of SMP scaffolds, many studies have focused on improving the therapeutic potential of SMP scaffolds in various diseases [ 28 ]. However, SMP scaffolds have different property requirements in practical applications.…”

Feasibility of aortic aneurysm sac embolization using a novel shape memory polymer embolic device

“…Ultra-low-density polyurethane shape memory polymer is a novel embolic material now available as vascular plugs [ 34 – 36 ]. Shape memory polymer devices (IMPEDE-FX Embolization Plug, Shape Memory Medical, Santa Clara, CA, USA) are supplied in a stable crimped form for catheter delivery, and the devices self-expand to a specific volume upon exposure to blood, as they “remember” the manufactured shape.…”

A novel self-expanding shape memory polymer coil for intracranial aneurysm embolization: 1 year follow-up in Chile

“…The expanded form has a high surface area and supports thrombus formation throughout its structure. The use of embolic devices based on shape memory polymer in the peripheral vasculature and aorta has been reported 13–15. The shape memory polymer is bioabsorbable,16 although the timeline for absorption is unknown in human clinical cases.…”