Shape Memory Medical Inc., a developer specializing in custom shape memory polymers for endovascular markets, has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA). The approval allows the company to initiate a prospective, multicenter trial to assess the IMPEDE-FX RapidFill Device’s safety and efficacy in abdominal aortic aneurysm (AAA) sac behavior.

AAA-SHAPE Pivotal Trial: A Milestone in Aortic Aneurysm Treatment

Ted Ruppel, President and CEO of Shape Memory Medical, emphasized the significance of this approval: “Securing a first-round FDA approval for AAA-SHAPE marks a significant milestone in the clinical development of the novel shape memory polymer technology for treatment of aortic aneurysms.” The AAA-SHAPE trial aims to tackle problems related to failed aneurysm regression or expansion within a year following elective endovascular aneurysm repair (EVAR), issues that lead to secondary interventions and increased mortality rates. The study will compare standard EVAR with EVAR plus sac management using the IMPEDE-FX RapidFill device.

Trial Design and Key Endpoints

The AAA-SHAPE trial, which stands for Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion, will enroll 180 patients across 40 sites in the U.S., Europe, and New Zealand. Patients will be randomly assigned either to the treatment arm, which combines standard EVAR with sac management using IMPEDE-FX RapidFill, or to the control arm that uses standard EVAR. The trial will monitor and compare sac diameter and volume changes, endoleak rates, secondary interventions, and mortality over a five-year period.

IMPEDE-FX RapidFill: The Investigational Device

IMPEDE-FX RapidFill employs a proprietary shape memory polymer, a porous polyurethane scaffold that self-expands upon blood contact. The device is designed to support commercially-available EVAR stent grafts, promoting aneurysm thrombosis and sac shrinkage.

Earlier Studies and Future Anticipation

The upcoming AAA-SHAPE Pivotal Trial follows early feasibility studies that involved 35 patients in New Zealand and the Netherlands. Marc Schermerhorn, MD, and Principal Investigator of the AAA-SHAPE Pivotal Trial, said: “The AAA-SHAPE early feasibility studies have been key to validating the procedural techniques and best practices that we will leverage in the pivotal trial. We are excited to initiate this widely-anticipated trial in the U.S. and abroad.”

With FDA IDE approval, Shape Memory Medical sets the stage for a crucial trial that aims to enhance the treatment landscape for patients with abdominal aortic aneurysms.

  abdominal aortic aneurysm, IMPEDE-FX RapidFill, Marc Schermerhorn, Shape Memory Medical, Ted Ruppel, USA