Shape Memory Medical AAA-SHAPE Pivotal Trial Commences European Enrollment

February 20, 2025—Shape Memory Medical Inc. announced the first European patient enrollment in the AAA-SHAPE pivotal trial. The patient was treated by Jan Heyligers, MD, consultant vascular surgeon, and Professor Patrick Vriens, MD, vascular surgeon, at Elisabeth TweeSteden Hospital in Tilburg, the Netherlands.

According to the company, the prospective, multicenter, randomized, open-label trial is intended to determine the safety and effectiveness of Shape Memory Medical’s Impede-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

The company stated that the investigational Impede-FX RapidFill device incorporates Shape Memory Medical’s shape memory polymer, a porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood.

In the pivotal trial, 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.

The AAA-SHAPE pivotal trial will enroll 180 patients with infrarenal AAAs at up to 50 sites in the United States, Europe, and New Zealand. Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions, stated the company.

In June 2024, the company announced commencement of the trial with the first patient treated in the United States.

AAA-SHAPE is led by National Principal Investigator Marc Schermerhorn, MD, Chief of Vascular Surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

“We congratulate Dr. Heyligers, Prof. Vriens, and the clinical study team at Elisabeth TweeSteden Hospital for being the first center in Europe to enroll in the AAA-SHAPE pivotal trial,” commented Dr. Schermerhorn in the company’s press release. “This milestone reflects the unwavering dedication of the physician investigators to advance embolization solutions and enhance patient care worldwide.”

Dr. Heyligers added, “We are proud to be the first site in Europe to treat a patient in this groundbreaking trial. Research shows that 60% of aneurysms either fail to regress or expand within a year after EVAR, often leading to rehospitalizations, additional interventions, and higher mortality rates.”

Dr. Heyligers continued, “The results of this study will be essential in determining whether the Impede-FX RapidFill, with its unique properties, can significantly enhance post-EVAR AAA outcomes and elevate the standard of patient care.”

The company stated that the AAA-SHAPE pivotal trial builds upon the AAA-SHAPE early feasibility study, which enrolled 35 patients in New Zealand and the Netherlands to assess the use of Impede-FX RapidFill for AAA sac embolization during EVAR.

In countries recognizing CE Mark approval, the Impede-FX RapidFill is indicated 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 law to investigational use, advised the company.