Shape Memory Medical has announced the first European patient enrollment in its AAA-SHAPE Pivotal Trial at Elisabeth TweeSteden Hospital in Tilburg, the Netherlands. The patient was treated by Dr. Jan Heyligers and Professor Dr. Patrick Vriens, marking a significant milestone in the company's evaluation of its innovative IMPEDE-FX RapidFill Device.
The AAA-SHAPE (Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion) trial is a prospective, multicenter, randomized, open-label study designed to assess the safety and effectiveness of the IMPEDE-FX RapidFill Device when used alongside standard endovascular aneurysm repair (EVAR) procedures.
"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. "This milestone reflects the unwavering dedication of the physician investigators to advance embolization solutions and enhance patient care worldwide."
Trial Design and Objectives
The pivotal trial will enroll 180 patients with infrarenal abdominal aortic aneurysms (AAA) across up to 50 sites in the United States, Europe, and New Zealand. The study's primary endpoints will compare aneurysm sac diameter and volume changes, endoleak rates, and the need for secondary interventions between standard EVAR and EVAR with the IMPEDE-FX RapidFill device.
Dr. Heyligers highlighted the clinical significance of the 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."
Innovative Technology
The IMPEDE-FX RapidFill device incorporates Shape Memory Medical's proprietary shape memory polymer technology. This porous, radiolucent, embolic scaffold is delivered in a crimped state via catheter and self-expands upon contact with blood. In the AAA-SHAPE trial, the device is intended to fill the aneurysm blood lumen surrounding a commercially available EVAR stent graft, with the goal of promoting aneurysm thrombosis and sac shrinkage.
This approach addresses a significant limitation of current EVAR procedures. Despite being less invasive than open surgical repair, EVAR is associated with a substantial rate of aneurysm persistence or expansion, which can necessitate additional interventions and increase mortality risk.
Building on Previous Research
The current pivotal trial builds upon the AAA-SHAPE early feasibility study, which enrolled 35 patients in New Zealand and the Netherlands to evaluate the use of IMPEDE-FX RapidFill for AAA sac embolization during EVAR. Investigators like Dr. Heyligers who participated in the earlier study are now applying key learnings to this pivotal phase of the research program.
Clinical Context
Abdominal aortic aneurysms affect approximately 4-8% of men and 1-3% of women over age 65, with rupture carrying a mortality rate of 80-90%. While EVAR has revolutionized AAA treatment by offering a less invasive alternative to open surgery, long-term outcomes remain a concern, with up to 20% of patients requiring reintervention within five years.
The IMPEDE-FX RapidFill represents a potential advancement in addressing these limitations by promoting more complete aneurysm exclusion and thrombosis. If successful, this approach could reduce the need for secondary interventions and improve long-term outcomes for AAA patients undergoing EVAR.
Shape Memory Medical, based in California, focuses on developing innovative therapeutic solutions using shape memory polymer technology. The company has already commercialized devices in the embolization space and is actively leveraging its platform technology for complex aortic pathologies.
In the United States, the IMPEDE-FX RapidFill remains an investigational device, limited by Federal law to investigational use, while the company's IMPEDE and IMPEDE-FX Embolization Plugs have received regulatory approvals in various markets including the US, Europe, and Japan.
