September 16, 2020
First Patient Enrollment in Shape Memory Medical AAA-SHAPE Study
September 16, 2020—Shape Memory Medical Inc. announced the initiation of the company’s AAA-SHAPE prospective safety study of the Impede-FX embolization plug device when used for abdominal aortic aneurysm (AAA) sac filling during elective endovascular aneurysm repair (EVAR). The study will enroll up to 15 patients outside of the United States.
The study’s first procedure was performed by interventional radiologist Andrew Holden, MBChB, and vascular surgeon Andrew Hill, MBChB, at Auckland City Hospital in Auckland, New Zealand. Dr. Holden is Principal Investigator for the study.
“We are excited to be part of the AAA-SHAPE study,” commented Dr. Holden in the company’s press release. “The concept of aneurysm sac management in combination with traditional EVAR could address an important unmet need in AAA patients, and we look forward to seeing our follow-up imaging results.”
Shape Memory Medical has received FDA clearance and European CE Mark approval for the Impede-FX for peripheral embolization applications. In the United States, the Impede-FX is currently indicated for use with the Impede embolization plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. In countries recognizing CE Mark approval, the Impede-FX embolization plug is indicated for use to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Independent of the AAA-SHAPE study, > 15 cases using Impede-FX for endoleak prevention and AAA sac filling concomitant with EVAR have been reported by Alexander Massmann, MD, at Saarland University Medical Center in Homburg/Saar, Germany, and Arne Schwindt, MD, at St. Franziskus Hospital in Münster, Germany.
“We are encouraged by our early results, and we believe that clinical studies will be valuable to validate our experience,” stated Dr. Massmann in the announcement.
Dr. Schwindt added, “AAA sac expansion following EVAR is a common complication associated with secondary intervention, rupture, and mortality, and we look forward to exploring the longer-term role of Shape Memory Polymer in the management of AAA patients.”