Shape Memory Medical has announced the completion of patient enrolment in AAA-SHAPE, the company’s prospective, multicentre early feasibility safety study of the Impede-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).
“We are pleased to reach this critical milestone in our AAA-SHAPE clinical programme,” said Ted Ruppel, president and chief executive officer of Shape Memory Medical. “We would like to thank the patients, investigators, and clinical study teams for their important contributions, and we look forward to evaluating the follow-up data to come.” The AAA-SHAPE study, which enrolled a combined 35 patients across two centres in New Zealand and in three centres in The Netherlands, will follow patients for two years.
Shape Memory Medical notes that Impede-FX RapidFill, the study device, incorporates a proprietary shape memory polymer, which is a high volume, porous embolic material that self-expands upon contact with blood.
According to the company, AAA-SHAPE is the first prospective clinical trial to evaluate the application of this novel material in AAA patients and its potential to improve aneurysm sac regression rates following EVAR.
“We have been talking for years about the need to directly manage the AAA sac due to the link between aneurysm failure to regress post EVAR and increased mortality risk,” said Andrew Holden (Auckland City Hospital, Auckland, New Zealand), principal investigator for AAA-SHAPE New Zealand. “Impede-FX RapidFill could be a significant tool for addressing this need, so we could not be more pleased to participate in AAA-SHAPE.”
Michel Reijnen (Rijnstate Hospital, Arnhem, The Netherlands), principal investigator for AAA-SHAPE Netherlands added, “Although we are still early in the course of patient follow-up, we are seeing signals of impressive sac shrinkage at six months and one year. We look forward to the ongoing evaluation of these patients and how their aneurysms respond longer-term.”