SANTA CLARA, Calif.--(BUSINESS WIRE)--Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that the Food and Drug Administration (FDA) granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).
“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,” said Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical Inc. “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.”
AAA-SHAPE – Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion – 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 (the treatment arm) or to standard EVAR (the control arm). Key endpoints will compare sac diameter and volume change, endoleak rates, secondary interventions, and mortality through five years.
The investigational device, IMPEDE-FX RapidFill, incorporates the novel shape memory polymer, a proprietary, porous, polyurethane 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.
The AAA-SHAPE Pivotal Trial is preceded by the AAA-SHAPE early feasibility studies which enrolled a combined 35 patients in New Zealand and the Netherlands. This early experience was recently described by Holden et al. in the Journal of Vascular Surgery: Cases, Innovations, and Techniques.
“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,” said Marc Schermerhorn, MD, Chief of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center in Boston, Massachusetts, and principal investigator of the AAA-SHAPE Pivotal Trial. “We are excited to initiate this widely-anticipated trial in the U.S. and abroad.”
Joining Dr. Schermerhorn as co-principal investigators are Virendra Patel, MD, MPH, Chief of Vascular Surgery, New York Presbyterian/Columbia University Irving Medical Center and Ross Milner, MD, Chief, Section of Vascular Surgery and Endovascular Therapy, University of Chicago Medicine.
“We used to consider both aneurysm regression and stability as indicators of a successful EVAR outcome. However, contemporary data reveals that stable sacs are not as benign as once thought and that any failure of the sac to regress is associated with higher long-term mortality,” said Dr. Patel. “Shape memory polymer is a meaningful advancement in AAA repair and has the potential to address these unmet needs.”
Dr. Milner added, “I commend the Company on the decision to pursue a randomized controlled trial. This head-to-head study will offer the level 1 evidence the vascular community will seek to determine the potential role of shape memory polymer in the management of AAA patients.”
About Shape Memory Medical
Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers, with devices approved in more than 25 countries spanning regions in Asia, the Middle East, Europe, the Americas and Australia. 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 IMPEDE-FX RapidFill Device is not available in the United States or Japan. For more information, visit www.shapemem.com.