Shape Memory Medical Begins Enrollment in FLAGSHIP Study Evaluating Novel False Lumen Embolization Technology

SAN JOSE, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular applications, today announced enrollment of the first patients in FLAGSHIP, the Company’s prospective, single‑arm, open‑label first‑in‑human study evaluating its investigational False Lumen Embolization (FLE) System for the treatment of aortic dissection.

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

FLAGSHIP (False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer) is designed to evaluate safety and preliminary signs of efficacy of the FLE System for treatment of aortic dissection false lumen. The study will enroll up to 30 patients with follow-up through two years.

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

Purpose-built for embolization of an aortic dissection false lumen, the FLE System represents a significant advancement in volumetric embolization compared to the Company’s commercially available IMPEDE^® Embolization Plug family. Investigational models include 18 mm, 24 mm, and 36 mm diameters (when implant is fully expanded), and in single and multi-segment configurations. The largest-volume FLE System implant delivers approximately 76 times the volume of the Company’s largest commercially available plug, enabling treatment of a variety of false lumen sizes.

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

“This first enrollment in FLAGSHIP represents an important step forward for our investigational aortic program,” said Ted Ruppel, Chief Executive Officer of Shape Memory Medical. “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.”

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

About Shape Memory Medical

Shape Memory Medical is a California-based, global medical device company developing innovative 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 under EU MDR. 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. The IMPEDE-FX RapidFill Device is not available in Japan. The False Lumen Embolization System is an investigational device, limited to investigational use.