Shape Memory Medical Begins European Enrollment in AAA-SHAPE Trial
Shape Memory Medical Inc., a developer of custom shape memory polymers for endovascular markets, has announced the first European enrollment in the AAA-SHAPE Pivotal Trial. This prospective, multicenter, randomized, open-label trial aims to assess the safety and effectiveness of the IMPEDE-FX RapidFill® Device in improving abdominal aortic aneurysm (AAA) sac behavior when used alongside elective endovascular aneurysm repair (EVAR). The first patient was treated by Dr. Jan Heyligers, MD, PhD, and Professor Dr. Patrick Vriens, MD, PhD, both vascular surgeons at Elisabeth TweeSteden Hospital in Tilburg, the Netherlands.
Shape Memory Medical Inc., a leading innovator in the development of custom shape memory polymers for the endovascular market, recently announced a major milestone in the AAA-SHAPE Pivotal Trial with the first enrollment of a patient in Europe. The patient was treated by Dr. Jan Heyligers, MD, PhD, consultant vascular surgeon, and Professor Dr. Patrick Vriens, MD, PhD, vascular surgeon, at Elisabeth TweeSteden Hospital in Tilburg, the Netherlands. This marks an important step in the trial, which is designed to evaluate the safety and effectiveness of Shape Memory Medical’s IMPEDE-FX RapidFill® Device in improving abdominal aortic aneurysm (AAA) sac behavior when used in conjunction with elective endovascular aneurysm repair (EVAR).
Dr. Marc Schermerhorn, the National Principal Investigator for the AAA-SHAPE trial and Chief of Vascular Surgery at Beth Israel Deaconess Medical Center in Boston, expressed his congratulations: “We congratulate Dr. Heyligers, Professor 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. This milestone reflects the unwavering dedication of the physician investigators to advance embolization solutions and enhance patient care worldwide.”
The AAA-SHAPE trial is a prospective, multicenter, randomized, open-label study that will enroll 180 patients across up to 50 sites in the U.S., Europe, and New Zealand. The trial is focused on patients with infrarenal abdominal aortic aneurysms, a serious condition that requires timely and effective intervention. Researchers will measure key endpoints such as changes in sac diameter and volume, endoleak rates, and the need for secondary interventions to assess the impact of IMPEDE-FX RapidFill on AAA outcomes.
Dr. Heyligers, who treated the first patient in the European trial, shared his excitement about being part of such an important study: “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. 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 investigational device, IMPEDE-FX RapidFill, is a novel embolic scaffold developed by Shape Memory Medical. It incorporates a shape memory polymer that is porous, radiolucent, and designed to self-expand upon contact with blood. The device is crimped for catheter delivery and, once deployed, expands to fill the aneurysm blood lumen around a commercially available EVAR stent graft. This process promotes aneurysm thrombosis and helps facilitate sac shrinkage, which could lead to improved long-term outcomes for patients.
The AAA-SHAPE Pivotal Trial follows the earlier AAA-SHAPE feasibility study, which enrolled 35 patients in New Zealand and the Netherlands. This earlier study was instrumental in assessing the use of IMPEDE-FX RapidFill for abdominal aortic aneurysm sac embolization during EVAR procedures. The findings from the early feasibility study have provided valuable insights that are now being applied in the pivotal trial to refine the approach and further evaluate the device’s effectiveness.
Shape Memory Medical’s involvement in the development of embolization solutions reflects the company’s broader commitment to advancing innovative therapeutic technologies. With a focus on shape memory polymer technology, Shape Memory Medical is continually exploring new ways to address complex vascular pathologies. The company has already commercialized devices in the embolization space, and it is actively leveraging its platform technology to develop novel applications in various areas of the medical field.
In addition to the European enrollment in the AAA-SHAPE trial, the company has achieved significant regulatory milestones. In countries where CE marking is recognized, devices such as the IMPEDE and IMPEDE-FX Embolization Plugs, along with IMPEDE-FX RapidFill, are approved for use in obstructing or reducing the rate of blood flow in peripheral vasculature. Additionally, the IMPEDE and IMPEDE-FX Embolization Plugs are PMDA approved in Japan. In the U.S., the IMPEDE Embolization Plug is indicated for use in obstructing blood flow in peripheral vasculature, while the IMPEDE-FX Embolization Plug is used in conjunction with the IMPEDE plug for similar applications. However, the IMPEDE-FX RapidFill device is still considered investigational in the United States and is limited to clinical trials.
Shape Memory Medical continues to lead the way in the development of transformative medical devices, with the IMPEDE-FX RapidFill being just one example of the company’s groundbreaking work. The AAA-SHAPE trial, which is rapidly advancing across multiple sites in the U.S. and Europe, will provide crucial data on the device’s potential to improve outcomes for patients undergoing EVAR for abdominal aortic aneurysms.
The success of the trial, along with the dedication of the physician investigators and clinical study teams, promises to make a significant impact on the field of endovascular aneurysm repair and further enhance the standard of care for patients with complex aortic pathologies. As the study progresses, Shape Memory Medical remains committed to its mission of improving patient outcomes and advancing the science of shape memory polymer technology in medicine.
