Enrollment Ends in Shape Memory Medical’s Trial for the IMPEDE‑FX RapidFill Device

Shape Memory Medical Inc. has completed enrollment in the AAA‑SHAPE Pivotal Trial, a prospective, randomized, open‑label controlled study evaluating the safety and effectiveness of the IMPEDE‑FX RapidFill Device when used alongside endovascular aneurysm repair (EVAR) to improve abdominal aortic aneurysm (AAA) sac behavior.

AAA-SHAPE randomized 180 patients at 48 centers in the United States, Europe, and New Zealand in a two-to-one ratio to receive either EVAR plus sac management with IMPEDE-FX RapidFill or standard EVAR alone. Participants will be followed for five 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 one year.

“We are grateful to the patients, investigators, proctors, and clinical study teams who made this milestone possible. Completion of enrollment advances our strategy to build pivotal evidence for the first dedicated sac management therapy evaluated in a randomized EVAR trial,” Shape Memory Medical President/CEO Ted Ruppel said.

Study administrators enrolled the final participant at Mayo Clinic in Rochester, Minn. Randall DeMartino, M.D., chair of Vascular and Endovascular Surgery, is the trial’s principal investigator.

An abdominal aortic aneurysm is a dangerous enlargement of the body’s main artery as it passes through the abdomen. If the aneurysm continues to grow, it can rupture and cause life-threatening internal bleeding. EVAR has transformed AAA treatment by reducing pressure on the aneurysm, but the aneurysm sac remains and may continue to pose a risk if it does not shrink over time.

“AAA-SHAPE addresses an important question in EVAR: whether managing the aneurysm sac at the time of EVAR can improve sac regression,” stated Marc Schermerhorn, M.D., global principal investigator for AAA-SHAPE and chief of Vascular and Endovascular Surgery at Beth Israel Deaconess Medical Center in Boston. “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.”

The investigational IMPEDE‑FX RapidFill device incorporates Shape Memory Medical’s shape memory polymer technology. Delivered through a catheter, the device expands when exposed to blood and creates a radiolucent, porous scaffold designed to fill the space around an EVAR stent graft. In AAA-SHAPE, it is intended to promote clot formation within the aneurysm sac and support sac shrinkage over time.

“EVAR remains the gold standard repair for AAA, but it does not directly treat the aneurysm sac,” commented Virendra Patel, M.D., global co-principal investigator for AAA-SHAPE and chief of Vascular Surgery at New York-Presbyterian/Columbia University Irving Medical Center. “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.”

Before the AAA-SHAPE Pivotal Trial, the AAA-SHAPE early feasibility studies enrolled 35 patients in New Zealand and the Netherlands. Three-year follow-up data are expected to provide additional insight into the long-term performance of the investigational device and its potential role in promoting aneurysm sac shrinkage after EVAR.

Shape Memory Medical Inc. is a global medical device company advancing therapies using shape memory polymer technology. With regulatory approvals in more than 40 countries and over 3,500 patients treated worldwide, the firm is leveraging its platform to address unmet needs in aortic interventions and develop solutions for complex aortic disease. In addition to the AAA-SHAPE Pivotal Trial, Shape Memory Medical is currently enrolling patients in the FLAGSHIP first-in-human study in New Zealand, evaluating the safety and early feasibility of a shape memory polymer-based investigational device for embolization of the false lumen during or after aortic dissection repair.

The IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill are CE Mark approved. The IMPEDE and IMPEDE-FX Embolization Plugs are approved in Japan and cleared for use in the United States. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature, and the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. In the United States, IMPEDE-FX RapidFill is an investigational device, limited by law to investigational use.