Shape Memory Medical Celebrates Treatment of 3000th Patient

AAA-SHAPE RCT Enrollment Surpasses 25 Percent Mark

SAN JOSE, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc., innovator of shape memory polymer for endovascular applications, today announced that its proprietary platform has been used to treat its 3,000^th patient—a significant milestone in the company’s commercialization and clinical strategy. The patient was enrolled in the company’s AAA-SHAPE Global Randomized Controlled Pivotal Trial, which has now surpassed 25% enrollment. This achievement reflects strong clinical adoption and represents meaningful progress toward regulatory and market expansion objectives across the company’s product portfolio.

Developed from 25 years of pioneering polymer research—originating at Lawrence Livermore National Laboratory (LLNL) and further advanced at Texas A&M University—shape memory polymer represents a groundbreaking innovation in medical device technology. Unlike traditional metal embolization devices, shape memory polymer offers a softer, more conformable solution that adapts seamlessly to the patient’s anatomy, filling the treated vessel or lesion without exerting unnecessary force. Additionally, its radiolucent properties enhance imaging clarity during procedures and follow-up assessments, improving visualization and precision.

“We are deeply grateful to our physician collaborators for their dedication and partnership in advancing our novel technology,” said Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical. The growing adoption of the company’s technology is driven by real-world embolization experiences in the treatment of peripheral arteries and veins, along with increasing clinical trial enrollment. This includes the EMBO Post-Market Surveillance Study in the United Kingdom and Germany, as well as the AAA-SHAPE Global Randomized Controlled Pivotal Trial.

The milestone patient was treated by Bjoern Suckow, MD, Associate Professor of Surgery, Geisel School of Medicine, Dartmouth Hitchcock Medical Center and AAA-SHAPE investigator. “We are proud to be a part of this groundbreaking trial to learn how shape memory polymer influences outcomes in patients with abdominal aortic aneurysms," said Dr. Suckow.

Since the launch of the shape memory polymer IMPEDE Embolization Plug in the US in 2017, the company has expanded its presence in over 30 countries, and completed a facility move to scale its research and development and production capabilities.

About Shape Memory Medical

Shape Memory Medical is a California-based, global medical device company focused on innovative therapeutic solutions using shape memory polymer technology. With commercialized devices in embolization space, the company is actively leveraging its platform technology to develop novel applications for the management of complex aortic pathologies.

Alongside CE Mark approvals, 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. For more information, visit www.shapemem.com.