Shape Memory Medical Completes Enrollment in AAA-SHAPE EFS, Evaluating Impede-FX RapidFill Device

August 29, 2022—Shape Memory Medical Inc. announced the completion of patient enrollment in AAA-SHAPE, a prospective multicenter 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).

Shape Memory Medical stated that the Impede-FX RapidFill device incorporates the company's shape memory polymer, which is a high-volume, porous embolic material that self-expands upon contact with blood.

AAA-SHAPE is the first prospective clinical trial to evaluate the application of this material in AAA patients and its potential to improve aneurysm sac regression rates after EVAR, noted the company.

According to the company, the AAA-SHAPE study enrolled 35 patients across two centers in New Zealand and three centers in the Netherlands. The patients will be followed for 2 years.

Andrew Holden, MBChB, is principal investigator for AAA-SHAPE New Zealand. Michel Reijnen, MD, is Principal Investigator for AAA-SHAPE Netherlands. Dr. Holden is an interventional radiologist at Auckland City Hospital in Auckland, New Zealand. Dr. Reijnen is a vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands.

“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,” commented Prof. Holden in the company’s press release. “Impede-FX RapidFill could be a significant tool for addressing this need, so we could not be more pleased to participate in AAA-SHAPE.”

Dr. Reijnen added, “Although we are still early in the course of patient follow-up, we are seeing signals of impressive sac shrinkage at 6 months and 1 year. We look forward to the ongoing evaluation of these patients and how their aneurysms respond longer term.”