Shape Memory Medical Inc., developer of the only commercially available volume-expanding shape memory polymer for endovascular embolization applications, announced it has reached 50 percent enrollment in its ongoing AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used in conjunction with elective endovascular aneurysm repair (EVAR).

The patient was treated by Aleem Mirza, MD, Principal Investigator and Vascular Surgeon at Orlando Health Heart and Vascular Institute Orlando, Florida. “We congratulate Dr. Mirza and the entire clinical study team at Orlando Health for enrolling the 90^th patient in the AAA-SHAPE Pivotal Trial. AAA-SHAPE is the first randomized controlled trial comparing EVAR plus sac management with IMPEDE-FX RapidFill to standard EVAR alone. The results will be critical in evaluating the potential of IMPEDE-FX RapidFill to promote sac regression and improve outcomes for AAA patients,” said Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical Inc.

AAA-SHAPE – Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion – will enroll 180 patients with infrarenal abdominal aortic aneurysms (AAA) across up to 50 sites in the U.S., Europe, and New Zealand. Study participants will be randomized 2:1, either to EVAR plus sac management with IMPEDE-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.

The investigational device, IMPEDE-FX RapidFill, incorporates Shape Memory Medical’s novel shape memory polymer, a proprietary, porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood. In AAA-SHAPE, IMPEDE-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.

Prior to the AAA-SHAPE Pivotal Trial, the AAA-SHAPE early feasibility studies enrolled a total of 35 patients across sites in New Zealand and the Netherlands. Three-year follow-up data from these studies are scheduled to be presented at the upcoming VEITH Symposium in November, offering valuable insights into the long-term performance of the investigational device.

“Published data show that approximately 60 percent of abdominal aortic aneurysms fail to regress—or even expand—within the first year following EVAR, which has been associated with increased rates of reintervention, rehospitalization, and mortality. By promoting sac regression, we have the possibility to significantly improve long-term outcomes for patients undergoing AAA repair,” explained Dr. Virendra Patel, MD, MPH, AAA-SHAPE Global Co- Principal Investigator and Chief of Vascular Surgery and Endovascular Interventions, New York Presbyterian/Columbia University Irving Medical Center. “We appreciate all the centers who are actively recruiting patients to participate in this important trial. We are highly anticipating the completion of the trial which we believe will provide valuable answers about the potentially important role of sac management in endovascular abdominal aneurysm repair.”

“We are proud to have treated the 90th patient within the AAA-SHAPE Pivotal Trial and to contribute to this important clinical milestone,” commented Dr. Mirza. “The IMPEDE-FX RapidFill’s unique properties may offer meaningful advantages in improving post-EVAR outcomes, and we look forward to the insights this study will provide.”

About Shape Memory Medical

Shape Memory Medical Inc. is a California-based, global medical device company dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers, with devices approved in more than 40 countries spanning regions in Asia, the Middle East, Europe, the Americas and Australia and over 3500 patients treated worldwide. 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 Federal (or United States) law to investigational use. For more information, visit www.shapemem.com.

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