Shape Memory Medical Inc., developer of custom, proprietary shape memory polymers for the peripheral vascular and neurovascular markets, announced preliminary six-month results from the AAA-SHAPE Safety Trial. Data will be presented during the 49th Annual VEITH Symposium in New York City on Tuesday, November 15, 2022.
AAA-SHAPE is the Company’s prospective, multicenter early feasibility safety study of the IMPEDE-FX RapidFill® Device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). The trial enrolled a combined 35 patients across two centers in New Zealand and in three centers in the Netherlands, and patients will be followed for two years.
The data will be presented by Professor Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands and principal investigator for AAA-SHAPE Netherlands. “Active sac management may become an important addition to EVAR to improve the rate of sac shrinkage,” said Reijnen. “Approximately 40% of AAA patients undergoing EVAR experience sac shrinkage within one year, meaning that the remaining patients either show no improvement in aneurysm size or go on to experience sac growth with a poor prognosis. Adjunctive aneurysm sac filling with shape memory polymer at the time of EVAR has the potential to improve sac regression.”
AAA-SHAPE is the first prospective clinical trial to evaluate the application of shape memory polymer in AAA patients and its potential to remodel the AAA sac and improve aneurysm sac regression following EVAR. IMPEDE-FX RapidFill, the study device, incorporates the novel, high volume, porous embolic material which 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.
“Treating the AAA sac during EVAR with the IMPEDE-FX RapidFill device could fundamentally change how we treat this disease state,” explained Prof. Andrew Holden, MBChB, principal investigator for AAA-SHAPE New Zealand and interventional radiologist at Auckland City Hospital. “Although contrary to recent thinking, a stable aneurysm following EVAR is no longer sufficient, and seeing sac regression should be the first way to measure treatment success. Early observations from AAA-SHAPE are encouraging, and further follow-up and larger studies are needed to evaluate durability of outcomes.”
Complete cohort data is expected at the end of 2023.