Clinical Trials and Studies

Excitement builds over the AAA-SHAPE Pivotal Trial following 2-year early feasibility data with the novel shape memory polymer

Andrew Holden, MBChB and Dai Yamanouchi, MD, PhD – Charing Cross Symposium 2025

At this year’s Charing Cross (CX) Symposium (23–25 April, London, UK), two leading figures in the endovascular aneurysm repair (EVAR) field—Andrew Holden (Auckland City Hospital, Auckland, New Zealand) and Dai Yamanouchi (University of Wisconsin, Madison, USA)—sat down to discuss the potential benefits of active sac management with the investigational IMPEDE-FX RapidFill  device, remarking that sac shrinkage is key for a long term, durable EVAR procedure.

CX co-chairs host discussion on studies looking at pre-emptive AAA sac management with the novel shape memory polymer and its potential to improve post-EVAR sac regression.

Dittmar Bӧckler, MD, Andrew Holden, MBChB, and Marc Schermerhorn, MD – Charing Cross Symposium 2024

Professor Holden highlighted data from the AAA-SHAPE early feasibility studies that evaluated the IMPEDE-FX Embolization Plug for management of AAA sacs at the time of EVAR. This novel technology is comprised of shape memory polymer, a porous polyurethane scaffold that supports rapid conversion to organized thrombus, that Professor Holden reports could lead to sac shrinkage. Schermerhorn also highlighted the need for evidence from a randomized clinical trial and announced the initiation of the AAA-SHAPE Pivotal Trial.

Active sac management represents a “step forward” for EVAR

Jan Heyligers, MD, PhD, & Michel Reijnen, MD, PhD – VEITH Symposium 2023

“Despite significant technological improvements since its inception, endovascular repair of abdominal aortic aneurysms (AAA) is still associated with some of the same problems we experienced nearly 30 years ago,” Michel Reijnen (Arnhem, The Netherlands) remarked at the VEITHsymposium 2023 (14–18 November, New York, USA). One of these issues—and a significant unmet need in the aortic field—is the failure of an AAA to regress post-endovascular aneurysm repair (EVAR).

Shape memory polymer: “Another step down the road” toward active aneurysm sac management

Andrew Holden, MBChB, FRANZCR, EBIR & Michel Reijnen, MD, PhD – Charing Cross Symposium 2023

“There is an increasing awareness that we need to get aneurysm sacs to regress after endovascular aneurysm repair [EVAR],” Andrew Holden (Auckland, New Zealand) stated during a recent discussion with Michel Reijnen (Arnhem, The Netherlands) on potential solutions in this space from Shape Memory Medical.

Shape Memory Polymer addresses an “unmet need” for EVAR

Andrew Holden, MBChB, FRANZCR, EBIR & Michel Reijnen, MD, PhD – Charing Cross Symposium 2022

“When you compare it to other embolic agents it is completely different.”

Shape Memory Polymer Vascular Plugs
Holden, A, Buckley, B, Hill, A – CIRSE Summit 2021

“Porous shape memory polymer vascular embolization devices were safe and effective in this first in human clinical experience”