Shape Memory Medical, developer of custom shape memory polymers for endovascular markets, announced that one-year data from the AAA-SHAPE safety trial will be presented during the 50th annual VEITHsymposium (14–18 November, New York City, USA) on Tuesday, November 14, 2023.
AAA-SHAPE is the company’s prospective, multicentre, early feasibility study of the IMPEDE-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). The trial, which enrolled a combined 35 patients in New Zealand and The Netherlands, is evaluating the application of shape memory polymer in AAA patients and its potential to remodel the AAA sac and improve aneurysm sac regression following EVAR. Patients will be followed for five years.
Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands) and principal investigator for AAA-SHAPE Netherlands will present the data. “We are encouraged by the one-year results and how shape memory polymer technology may ultimately influence sac behaviour,” stated Reijnen.
IMPEDE-FX RapidFill, the study device, incorporates the company’s novel shape memory polymer, a proprietary, high volume, porous embolic material that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organised thrombus. Pre-clinical studies have shown that shape memory polymer is regenerative, activating the formation of new cellular growth as the thrombus remodels and the material is absorbed.
Andrew Holden, (Auckland City Hospital, Auckland, New Zealand) principal investigator of AAA-SHAPE New Zealand, remarked: “We are increasingly becoming more aware of the importance of AAA sac regression after EVAR. Active sac management with shape memory polymer may become an important addition to EVAR.”
“The availability of one-year data from the early feasibility study presented at VEITH marks an important milestone in the clinical development of shape memory polymer for aneurysm sac management,” said Ted Ruppel, president and CEO, Shape Memory Medical. “We look forward to the next phase of the AAA-SHAPE program in a head-to-head study.” The company recently announced US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate the AAA-SHAPE pivotal trial, a randomised controlled study comparing EVAR plus sac management with IMPEDE-FX RapidFill to standalone EVAR.