Shape Memory Medical Announces First Patient Enrollment in the AAA-SHAPE Netherlands Study
SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, announced the initiation of AAA-SHAPE Netherlands, 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 Dutch study’s first procedure was performed by Professor Michel Reijnen, MD, PhD, vascular surgeon at Rijnstate Hospital in Arnhem, the Netherlands.
Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical Inc. said, “We would like to congratulate Professor 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 program accelerates our ability to evaluate IMPEDE-FX RapidFill and its potential to improve sac regression in AAA patients following EVAR.” The study will enroll up to 15 patients across three centers 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 embolization 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 organized thrombus. Pre-clinical and clinical studies have shown that Shape Memory Polymer offers effective and predictable space filling, stable clot formation for sac embolization, and progressive healing as the material biodegrades.
“We are excited to contribute to AAA-SHAPE,” said Professor 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 behavior,” 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, MBChB, interventional radiologist at Auckland City Hospital. “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.
About Shape Memory Medical
Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers. 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. For more information, visit www.shapemem.com.