Shape Memory Medical has announced the initiation of AAA-SHAPE, the company’s prospective safety study of the Impede-FX embolisation plug devices when used for abdominal aortic aneurysm (AAA) sac filling during elective endovascular aneurysm repair (EVAR). The study’s first procedure was performed by interventional radiologist Andrew Holden and vascular surgeon Andrew Hill at Auckland City Hospital in Auckland, New Zealand.
The Impede-FX embolisation plug is comprised of Shape Memory polymer which is a porous, embolic scaffold. The biocompatible material is crimped for catheter delivery and self-expands to a “memorised” shape upon contact with blood for rapid conversion to organised thrombus.
According to a press release, pre-clinical studies in aneurysm models demonstrated advanced healing of the initial thrombus to mature collagenous connective tissue and aneurysm sac shrinkage.
In the USA, the Impede-FX embolisation plug is currently indicated for use with the Impede embolisation plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. In countries recognizing CE marking, the Impede-FX embolisation plug is indicated for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.
“We are excited to be part of the AAA-SHAPE study,” said Holden, principal investigator for the study. “The concept of aneurysm sac management in combination with traditional EVAR could address an important unmet need in AAA patients, and we look forward to seeing our follow-up imaging results.”
Independent of the AAA-SHAPE study, over 15 cases using Impede-FX for endoleak prevention and AAA sac filling concomitant with EVAR have been reported by Alexander Massmann (Saarland University Medical Center, Homburg/Saar, Germany) and Arne Schwindt (Franziskus Hospital, Münster, Germany).
“We are encouraged by our early results, and we believe that clinical studies will be valuable to validate our experience,” said Massmann. “AAA sac expansion following EVAR is a common complication associated with secondary intervention, rupture, and mortality, and we look forward to exploring the longer-term role of Shape Memory polymer in the management of AAA patients,” added Schwindt.
