Shape Memory Medical’s Pivotal AAA SHAPE Trial Completes Enrollment

July 8, 2026—Shape Memory Medical Inc., developer of a commercially available volume-expanding shape memory polymer for endovascular embolization, announced that it has completed enrollment in the AAA SHAPE pivotal trial of the company’s investigational Impede FX RapidFill device.

According to the company, the prospective, multicenter, randomized, open-label, controlled study is evaluating the safety and effectiveness of the Impede FX RapidFill device when used with endovascular aneurysm repair (EVAR) to improve abdominal aortic aneurysm (AAA) sac behavior.

As noted in the press release, the AAA-SHAPE study enrolled 180 patients at 48 centers across the United States, Europe, and New Zealand. The patients were randomized in a 2:1 ratio to receive either EVAR plus sac management with Impede-FX RapidFill or standard EVAR alone. Enrollment commenced in June 2024. The patients will be followed for 5 years.

Primary endpoints include 30-day freedom from major adverse events, aneurysm rupture, perforation, and conversion to open repair, as well as the proportion of patients achieving ≥ 10% aneurysm sac volume reduction without AAA-related intervention through 1 year, advised Shape Memory Medical.

The company advised that the Impede FX RapidFill device incorporates Shape Memory Medical’s shape memory polymer technology. The device is delivered through a catheter and then expands when exposed to blood to create a radiolucent, porous scaffold designed to fill the space around an EVAR stent graft.

In the trial, the device is intended to promote clot formation within the aneurysm sac and support sac shrinkage over time.

The trial’s Principal Investigator is Randall DeMartino, MD, Chair of Vascular and Endovascular Surgery at Mayo Clinic in Rochester, Minnesota, where the final patient was enrolled. Marc Schermerhorn, MD, is Global Principal Investigator and Virendra Patel, MD, is Global Co-Principal Investigator of the AAA-SHAPE trial.

“AAA-SHAPE addresses an important question in EVAR: whether managing the aneurysm sac at the time of EVAR can improve sac regression,” commented Dr. Schermerhorn in Shape Medical’s press release. “Sac behavior after EVAR is closely linked to long-term outcomes, yet no randomized controlled trial has evaluated a dedicated sac management strategy against standard EVAR alone. This study is designed to provide the evidence needed to answer that question.”

Dr. Patel added, “EVAR remains the gold standard repair for AAA, but it does not directly treat the aneurysm sac. We now recognize that lack of sac regression may be associated with increased long-term risk, including reintervention, rupture, and mortality. AAA-SHAPE is the first randomized trial designed to determine whether proactive sac management can improve those outcomes.”