One-Year Results from the AAA-SHAPE Early Feasibility Study to be Presented at VEITH 2023
SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced that one-year data from the AAA-SHAPE Safety Trial will be presented during the 50th Annual VEITH Symposium in New York City on Tuesday, November 14, 2023.
AAA-SHAPE is the Company’s prospective, multicenter, early feasibility study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). The trial, which enrolled a combined 35 patients in New Zealand and the Netherlands, is evaluating the application of shape memory polymer in AAA patients and its potential to remodel the AAA sac and improve aneurysm sac regression following EVAR. Patients will be followed for five years.
Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands and principal investigator for AAA-SHAPE Netherlands will present the data. “We are encouraged by the one-year results and how shape memory polymer technology may ultimately influence sac behavior,” stated Professor Reijnen.
IMPEDE-FX RapidFill, the study device, incorporates the Company’s novel shape memory polymer, a proprietary, high volume, porous embolic material that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organized thrombus. Pre-clinical studies have shown that shape memory polymer is regenerative, activating the formation of new cellular growth as the thrombus remodels and the material is absorbed.
Andrew Holden, MBChB, Director of Interventional Radiology at Auckland City Hospital in Auckland, New Zealand, and principal investigator of AAA-SHAPE New Zealand, remarked, “We are increasingly becoming more aware of the importance of AAA sac regression after EVAR. Active sac management with shape memory polymer may become an important addition to EVAR.”
“The availability of one-year data from the early feasibility study presented at VEITH marks an important milestone in the clinical development of shape memory polymer for aneurysm sac management,” said Ted Ruppel, President and CEO, Shape Memory Medical. “We look forward to the next phase of the AAA-SHAPE program in a head-to-head study.” The Company recently announced FDA investigational device exemption (IDE) approval to initiate the AAA-SHAPE Pivotal Trial, a randomized controlled study comparing EVAR plus sac management with IMPEDE-FX RapidFill to stand-alone EVAR.
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 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.