Shape Memory Medical Announces European Enrollment in the AAA-SHAPE Randomized Controlled Pivotal Trial

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first enrollment in Europe in the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR). 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.

“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,” said Dr. Marc Schermerhorn, AAA-SHAPE National Principal Investigator and Chief of Vascular Surgery at Beth Israel Deaconess Medical Center in Boston, MA. “This milestone reflects the unwavering dedication of the physician investigators to advance embolization solutions and enhance patient care worldwide.”

AAA-SHAPE – Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion – will enroll 180 patients with infrarenal abdominal aortic aneurysms (AAA) across up to 50 sites in the U.S., Europe, and New Zealand. Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.

“We are proud to be the first site in Europe to treat a patient in this groundbreaking trial,” said Dr. Heyligers. “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,” continued Heyligers.

IMPEDE-FX RapidFill, the investigational device, incorporates Shape Memory Medical’s novel shape memory polymer, a proprietary, porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood. In AAA-SHAPE, IMPEDE-FX RapidFill is intended to fill the aneurysm blood lumen around a commercially available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.

The AAA-SHAPE Pivotal trial builds upon the AAA-SHAPE early feasibility study which enrolled 35 patients in New Zealand and the Netherlands to assess the use of IMPEDE-FX RapidFill for abdominal aortic aneurysm (AAA) sac embolization during EVAR. Investigators like Dr. Heyligers who participated in the early feasibility study play an important role in applying initial key learnings of this application to this next phase of the AAA-SHAPE program.

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.

In countries recognizing CE marking, the IMPEDE and IMPEDE-FX Embolization Plugs and the IMPEDE-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE and IMPEDE-FX Embolization Plugs are PMDA approved in Japan. 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.

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