Shape Memory Medical Initiates Patient Enrollment in FLAGSHIP Study of Novel False Lumen Embolization Technology
Shape Memory Medical Inc. has announced a major clinical milestone with the enrollment of the first patients in its FLAGSHIP study, a first-in-human clinical trial evaluating the company’s investigational False Lumen Embolization (FLE) System for the treatment of aortic dissection. This development represents a significant step forward in advancing innovative endovascular therapies for a life-threatening cardiovascular condition that continues to pose substantial clinical challenges.
Aortic dissection is a serious and often fatal condition characterized by a tear in the inner layer of the aorta, the body’s largest artery. This tear allows blood to flow between the layers of the aortic wall, creating a secondary channel known as a “false lumen.” The presence of this false lumen can lead to persistent blood flow outside the normal vascular pathway, increasing the risk of complications such as aneurysmal expansion, rupture, organ malperfusion, and ultimately death. Despite advances in surgical and endovascular techniques, persistent perfusion of the false lumen remains a major predictor of poor long-term outcomes in patients with aortic dissection.
The newly initiated FLAGSHIP study—short for False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer—is a prospective, single-arm, open-label clinical trial designed to evaluate the safety and early efficacy signals of the FLE System. The study plans to enroll up to 30 patients and will include follow-up over a period of two years, allowing investigators to assess both short-term procedural outcomes and longer-term effects on aortic remodeling and disease progression.
The first procedures in the study were successfully performed at Auckland City Hospital, a leading center for advanced cardiovascular interventions. The procedures were conducted by Dr. Andrew Holden, an interventional radiologist and principal investigator, alongside Dr. Anastasia Dean, a vascular surgeon and study investigator. Their participation underscores the multidisciplinary approach often required in the management of complex aortic diseases.
In addition to the initial site, a second clinical center—Waikato Hospital—has been activated for the study. This site is led by Dr. Manar Khashram, a vascular surgeon and researcher, further expanding the trial’s reach and enabling broader patient enrollment within New Zealand. The activation of multiple sites reflects the company’s commitment to generating robust clinical data across different clinical settings.
The investigational FLE System has been purpose-built specifically for the embolization of the false lumen in aortic dissection, representing a novel approach compared to existing treatment strategies. Current standard-of-care interventions, such as thoracic endovascular aortic repair (TEVAR), primarily focus on sealing the primary entry tear in the aorta. While effective in many cases, TEVAR does not always eliminate blood flow into the false lumen, leaving patients at risk for continued disease progression.
The FLE System aims to address this gap by directly targeting the false lumen itself. By promoting thrombosis—essentially clotting—within the false lumen, the system is designed to reduce or eliminate abnormal blood flow, thereby supporting favorable aortic remodeling and reducing the risk of complications. This approach has the potential to complement existing therapies and improve long-term outcomes for patients with aortic dissection.
One of the key innovations of the FLE System lies in its ability to deliver large-volume embolization. Compared to the company’s commercially available IMPEDE Embolization Plug family, the investigational system offers a substantial increase in volumetric capacity. The FLE System is available in multiple sizes, including 18 mm, 24 mm, and 36 mm diameters when fully expanded, and can be configured in single or multi-segment formats to accommodate different anatomical needs.
Notably, the largest configuration of the FLE System delivers approximately 76 times the volume of the company’s largest currently available embolization plug. This significant increase in volume enables the treatment of a wide range of false lumen sizes, including large and complex anatomies that may be difficult to address with conventional devices. Such scalability is critical in aortic interventions, where patient anatomy can vary widely.
Like other technologies developed by Shape Memory Medical, the FLE System is based on the company’s proprietary shape memory polymer platform. This material is engineered to be delivered via catheter in a compact, compressed form and then expand upon contact with blood. Once deployed, the polymer scaffold conforms to the irregular geometry of the false lumen, filling the space effectively while maintaining flexibility and structural integrity.
The porous nature of the scaffold plays a crucial role in its therapeutic function. It is designed to promote organized thrombus formation, encouraging the body’s natural healing processes to stabilize the affected area. At the same time, the material is radiolucent, meaning it does not interfere significantly with imaging techniques such as X-ray or CT scans. This property allows clinicians to monitor the treated area more clearly during and after the procedure, which is particularly important in complex vascular interventions.
Ted Ruppel, Chief Executive Officer of Shape Memory Medical, emphasized the strategic importance of the FLAGSHIP study within the company’s broader clinical development program. He noted that the trial builds on the foundation established by the company’s earlier AAA-SHAPE feasibility studies, as well as the ongoing AAA-SHAPE randomized controlled pivotal trial, which is currently nearing full enrollment. These programs collectively demonstrate the versatility and scalability of the company’s shape memory polymer technology across multiple aortic pathologies.
Ruppel highlighted that the expansion into the aortic dissection market represents a natural progression for the platform, addressing a large and underserved patient population. By developing a comprehensive suite of endovascular solutions, Shape Memory Medical aims to provide clinicians with new tools to manage complex vascular diseases more effectively.
Clinical investigators involved in the study have also expressed optimism about the potential impact of the FLE System. Dr. Holden noted that persistent false lumen perfusion remains one of the most significant predictors of adverse outcomes in patients with aortic dissection. He emphasized that a dedicated technology designed specifically to thrombose the false lumen, particularly when used in conjunction with existing treatments like TEVAR, could address a major unmet clinical need.
The initiation of the FLAGSHIP study marks an important step in translating this innovative concept into clinical practice. As a first-in-human trial, the study will provide critical data on the safety and feasibility of the FLE System, as well as early indications of its effectiveness. These findings will be essential in guiding future development, including potential larger-scale trials and eventual regulatory submissions.
More broadly, the study reflects ongoing innovation in the field of endovascular therapy, where new materials and device designs are enabling more targeted and less invasive approaches to treating complex vascular conditions. The use of shape memory polymers, in particular, represents a promising area of research, offering unique properties that can be leveraged to improve patient outcomes.
In conclusion, the enrollment of the first patients in the FLAGSHIP study represents a significant milestone for Shape Memory Medical and the broader field of aortic disease treatment. By targeting the false lumen directly with a purpose-built embolization system, the company is advancing a novel therapeutic strategy that has the potential to address a critical unmet need. As the study progresses and additional data become available, the medical community will be closely watching to assess the impact of this innovative approach on the management of aortic dissection.
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.
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