Shape Memory Medical Nabs IDE Nod for AAA-SHAPE Head-to-Head Trial

Shape Memory Medical has been granted investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a trial to determine safety and effectiveness of its IMPEDE-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).
 
The AAA-SHAPE trial will enroll 180 patients with infrarenal abdominal aortic aneurysms (AAA) across 40 sites in the U.S., Europe, and New Zealand. Study participants will be randomized 2:1, either to EVAR plus sac management with IMPEDE-FX RapidFill or to standard EVAR
 
Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years.
 
“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,” Ted Ruppel, president and CEO of Shape Memory Medical, told the press. “Large studies report that 60 percent of aneurysms fail to regress or expand within one year following EVAR, a problem linked to rehospitalizations, secondary interventions, and increased mortality. AAA-SHAPE will directly compare EVAR plus sac management with IMPEDE-FX RapidFill to stand-alone EVAR to determine whether shape memory polymer improves patient outcomes post-EVAR.”
 
IMPEDE-FX RapidFill uses the novel shape memory polymer, a proprietary, porous, polyurethane scaffold crimped for catheter delivery and self-expands on contact with blood. In the AAA-SHAPE trial, the device is intended to fill the aneurysm blood lumen around a commercially available EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.