Shape Memory Medical Treats 1st Patient in AAA-SHAPE Pivotal Study

Shape Memory Medical announced the first patient treated in its AAA-SHAPE pivotal trial.
 
The prospective, multicenter, randomized, open-label trial is evaluating the company’s IMPEDE-FX RapidFill device to improve abdominal aortic aneurysm (AAA) sac behavior when used with endovascular aneurysm repair (EVAR). The first patient was treated by Raghu Motaganahalli, MD, Division Chief of Vascular Surgery and the Program Director of vascular surgery training programs at Indiana University School of Medicine.
 
“We are pleased to be the first site to treat a patient within the AAA-SHAPE Pivotal Trial,” commented Dr. Motaganahalli. “The outcomes of this important trial will help determine whether IMPEDE-FX RapidFill, with its unique properties, plays a meaningful role in post-EVAR AAA outcomes.”
 
AAA-SHAPE will enroll 180 patients with infrarenal AAA in up to 50 sites in the U.S., Europe, and New Zealand. Subjects will be randomized 2:1 either to EVAR plus sac management with IMPEDE-FX RapidFill or to standard EVAR. Endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.
 
The investigational IMPEDE-FX RapidFill uses Shape Memory Medical’s proprietary, porous, radiolucent, embolic shape memory scaffold. It’s crimped for catheter delivery and self-expands after contact with blood. In the AAA-SHAPE trial, it’s intended to fill the aneurysm blood lumen around an EVAR stent graft to promote aneurysm thrombosis and sac shrinkage.
 
“We would like to congratulate Dr. Motaganahalli and the clinical study team at Indiana University for being the first to enroll a patient in the AAA-SHAPE Pivotal Trial,” said Shape Memory Medical president and CEO Ted Ruppel. “This is the first randomized controlled trial comparing EVAR plus sac management with IMPEDE-FX RapidFill to stand-alone EVAR to evaluate shape memory polymer and its potential to improve sac regression in AAA patients.”