Shape Memory Medical Inc. has now enrolled half the total patients in its AAA-SHAPE Pivotal Trial, a prospective, multicenter study designed to determine safety and effectiveness of the IMPEDE-FX RapidFill Device in improving abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

The 90th patient was treated by Aleem Mirza, M.D., principal investigator and vascular surgeon at Orlando Health Heart and Vascular Institute Orlando, Fla. “We are proud to have treated the 90th patient within the AAA-SHAPE Pivotal Trial and to contribute to this important clinical milestone,” Dr. Mirza commented. “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.”

The randomized, open-label AAA-SHAPE trial—Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion—will enroll 180 patients with infrarenal abdominal aortic aneurysms (AAA) at up to 50 sites in the United States, Europe, and New Zealand. Study participants will be randomized two to one, 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.

“We congratulate Dr. Mirza and the entire clinical study team at Orlando Health for enrolling the 90th 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,” Shape Memory Medical President/CEO Ted Ruppel said.

The investigational device, IMPEDE-FX RapidFill, incorporates Shape Memory Medical’s 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 35 patients total at New Zealand and the Netherlands sites. Three-year follow-up data from these studies are scheduled to be presented this month, offering valuable insights into the long-term performance of the investigational device.

“Published data show that approximately 60% 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, M.D., AAA-SHAPE global co-principal investigator and chief of Vascular Surgery and Endovascular Interventions at New York Presbyterian/Columbia University Irving Medical Center. “We appreciate all the centers who are actively recruiting patients to participate in this trial. We are 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.”

Shape Memory Medical Inc. is a global medical device company developing 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 3,500 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.