Shape Memory Medical Initiates First-in-Human FLAGSHIP Study of False Lumen Embolization System

April 1, 2026—Shape Memory Medical has announced the first patient enrollments in the FLAGSHIP study, a prospective single-arm open-label first-in-human trial evaluating its investigational False Lumen Embolization (FLE) System for treatment of aortic dissection.

The FLAGSHIP study is designed to evaluate the safety and preliminary efficacy of the FLE System in patients with aortic dissection, the company said. Up to 30 patients will be enrolled, with follow-up extending to 2 years.

The first two procedures were performed at Auckland City Hospital in Auckland, New Zealand, by Andrew Holden, MBChB, an interventional radiologist and Principal Investigator, and Anastasia Dean, MB BS, a vascular surgeon and investigator. A second site at Waikato Hospital in Hamilton, New Zealand, has also been activated under the leadership of Manar Khashram, MBChB, PhD.

Shape Memory Medical notes that the FLE System is purpose-built for embolization of the false lumen and designed to deliver substantially greater volumetric fill compared with the company’s Impede Embolization Plug platform. Investigational device sizes include 18-, 24-, and 36-mm diameters, with both single- and multisegment configurations. According to the company, the largest implant provides approximately 76-fold greater volume than its largest commercially available plug. The system uses a porous shape-memory polymer scaffold delivered via catheter in a compressed state that self-expands upon contact with blood. The scaffold is intended to promote organized thrombus formation while conforming to irregular anatomy and minimizing imaging artifact due to its radiolucent properties.

“We are excited to participate in the FLAGSHIP study,” said Dr. Holden in the announcement. “Persistent false lumen perfusion remains one of the most significant predictors of adverse outcomes in aortic dissection. A dedicated technology designed to thrombose the false lumen and support positive remodeling alongside TEVAR has the potential to address a significant unmet clinical need.”