Shape Memory Medical has announced the initiation of AAA-SHAPE Netherlands, the company’s prospective, multicentre 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 Dutch study’s first procedure was performed by Michel Reijnen, vascular surgeon at Rijnstate Hospital in Arnhem, The Netherlands.
Ted Ruppel, president and chief executive officer of Shape Memory Medical said, “We would like to congratulate Michel Reijnen and the clinical study team at Rijnstate Hospital for a successful first AAA-SHAPE case in The Netherlands. The addition of Dutch sites to the AAA-SHAPE programme accelerates our ability to evaluate Impede-FX RapidFill and its potential to improve sac regression in AAA patients following EVAR.” The study will enrol up to 15 patients across three centres in The Netherlands, contributing to the AAA-SHAPE safety study, which is also currently enrolling up to 15 patients in Auckland, New Zealand.
The Impede-FX RapidFill device contains five Impede-FX, 12mm embolisation plugs preloaded into a single delivery introducer for fast and efficient delivery of the embolic material. This high-volume platform incorporates the novel Shape Memory Polymer, a porous, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organised thrombus. Preclinical and clinical studies have shown that Shape Memory Polymer offers effective and predictable space filling, stable clot formation for sac embolisation, and progressive healing as the material biodegrades.
“We are excited to contribute to AAA-SHAPE,” said Reijnen, principal investigator for AAA-SHAPE Netherlands. “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 behaviour,” continued Reijnen.
“We are very pleased to be working together with colleagues from the Netherlands to add to our growing experience with AAA-SHAPE,” said Andrew Holden, interventional radiologist at Auckland City Hospital in Auckland, New Zealand. “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,” continued Holden.