Enrollment Underway in Study of False Lumen Embolization Tech

The first patients have been enrolled in Shape Memory Medical Inc.’s prospective first‑in‑human study evaluating its investigational False Lumen Embolization (FLE) System for aortic dissection treatment.

Aortic dissection is a life‑threatening condition in which an aortic wall tear creates a secondary channel known as a “false lumen.” Persistent perfusion of this false lumen can lead to aneurysmal degeneration, rupture, and other serious complications, and remains a major predictor of adverse long-term outcomes.

The single-arm, open-label FLAGSHIP (False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer) is evaluating the FLE System’s safety and preliminary efficacy signs for treating aortic dissection false lumen. The study will eventually enroll up to 30 patients with a two-year follow-up.

The first two procedures were performed at Auckland City Hospital in Auckland, New Zealand, by Dr. Andrew Holden, interventional radiologist and principal study investigator; and Dr. Anastasia Dean, vascular surgeon and investigator. A second New Zealand site—Waikato Hospital in Hamilton—has been activated will be led by Dr. Manar Khashram, Ph.D.

“We are excited to participate in the FLAGSHIP study,” Dr. Holden stated. “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.”

Purpose-built for aortic dissection false lumen embolization, the FLE System is touted as a significant advancement in volumetric embolization compared to the company’s commercially available IMPEDE Embolization Plug. Investigational models include 18 mm, 24 mm, and 36 mm diameters (when the implant is fully expanded), and in single and multi-segment configurations. The largest-volume FLE System implant delivers approximately 76 times the volume of Shape Memory Medical’s largest commercially available plug, enabling doctors to treat various false lumen sizes.

Like the IMPEDE platform, the FLE System uses Shape Memory Medical’s proprietary porous shape memory polymer scaffold, which is delivered through a catheter in a compressed form and self-expands upon contact with blood. The scaffold is engineered to promote organized thrombus formation while conforming to irregular anatomy and maintaining radiolucency to minimize imaging artifacts.

“This first enrollment in FLAGSHIP represents an important step forward for our investigational aortic program,” Shape Memory Medical CEO Ted Ruppel stated. “Building on the foundation of our AAA-SHAPE feasibility studies and the momentum of our ongoing global AAA-SHAPE randomized controlled pivotal trial—now approximately 80% enrolled—FLAGSHIP extends our shape memory polymer platform into the large and underserved aortic dissection market. Together, these programs demonstrate the potential for our emerging technology to scale across a range of aortic pathologies and reinforces our commitment to building a comprehensive endovascular solution set.”

Shape Memory Medical is a California-based, global medical device company developing endovascular solutions using shape memory polymer technology. With commercialized devices approved in more than 45 countries across Asia, the Middle East, Europe, the Americas, and Australia—and over 3,500 patients treated worldwide—the company is advancing its platform technology to address complex aortic pathologies.

The IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill are approved in Europe. 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 used to obstruct or reduce blood flow rate in the peripheral vasculature, and the IMPEDE-FX Embolization Plug is used with the IMPEDE Embolization Plug to obstruct or reduce blood flow rate in the peripheral vasculature. In the United States, IMPEDE-FX RapidFill is an investigational device, limited by federal law to investigational use. The IMPEDE-FX RapidFill Device is not available in Japan. The False Lumen Embolization System is an investigational device, limited to investigational use.