Shape Memory Medical’s Impede-FX RapidFill Device Evaluated in AAA-SHAPE Netherlands Study

August 24, 2021—Shape Memory Medical Inc. announced the initiation of AAA-SHAPE Netherlands, the company’s prospective, multicenter, early feasibility study of its Impede-FX RapidFill device used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR).

According to Shape Memory, the study will enroll up to 15 patients at three centers in the Netherlands, contributing to the AAA-SHAPE safety study that is also currently enrolling up to 15 patients in Auckland, New Zealand. The Dutch study’s first procedure was performed by Professor Michel Reijnen, MD, a vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands, and Principal Investigator of the AAA-SHAPE Netherlands study.

“We are excited to contribute to AAA-SHAPE,” commented Prof. Reijnen in the company’s press release. “Patients who develop aneurysm sac shrinkage following EVAR have better outcomes than patients with a stable or growing aneurysm sac. We look forward to learning how the use of Impede-FX RapidFill in combination with EVAR influences sac behavior.”

Andrew Holden, MBChB, interventional radiologist at Auckland City Hospital in Auckland, New Zealand, added, “We are very pleased to be working together with colleagues from the Netherlands to add to our growing experience with AAA-SHAPE. Our preliminary experience with AAA-SHAPE has been very encouraging, and the first few patients have shown a reduction in AAA sac diameter at early follow-up.”

In the announcement, the company stated that the Impede-FX RapidFill device contains five 12-mm Impede-FX embolization plugs preloaded into a single delivery introducer for fast and efficient delivery of the embolic material. The high-volume platform incorporates the Shape Memory polymer, which is a porous embolic scaffold that is crimped for catheter delivery and self-expands on contact with blood for rapid conversion to organized thrombus.

Preclinical and clinical studies have shown that the Shape Memory polymer offers effective and predictable space filling, stable clot formation for sac embolization, and progressive healing as the material biodegrades, advised the company.