Shape Memory Medical Announces First Patient Treated in the AAA-SHAPE Randomized Controlled Pivotal Trial

The 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, Indianapolis, Indiana. “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. 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,” said Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical Inc.

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. Study participants will be randomized 2:1, either to EVAR plus sac management with IMPEDE-FX RapidFill (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, and secondary interventions.

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.

Prior to the AAA-SHAPE Pivotal Trial, the AAA-SHAPE early feasibility studies enrolled a combined 35 patients in New Zealand and the Netherlands.

“Large studies report that 60 percent of aneurysms either fail to regress or expand within one year following EVAR, a problem linked to rehospitalizations, secondary interventions, and increased mortality. Moving more patients toward sac regression has the potential for significant benefits,” said Dr. Marc Schermerhorn, AAA-SHAPE National Principal Investigator and Chief of Vascular Surgery at Beth Israel Deaconess Medical Center in Boston, MA.

“We are pleased to be the first site to treat a patient within the AAA-SHAPE Pivotal Trial,” commented Dr. Motaganahalli, Principal Investigator and Vascular Surgeon at Indiana University School of Medicine. “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.”

Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers. Neurovascular embolization products include the TrelliX® Embolic Coil, which is CE marked for use in the EU. Peripheral embolization products include the IMPEDE® and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill® Device. 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. 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. The IMPEDE and IMPEDE-FX Embolization Plugs are PMDA approved in Japan. The TrelliX Embolic Coil and IMPEDE-FX RapidFill Device are not available in the United States or Japan. 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.