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MDR certification secured for Impede embolization plug devices
Shape Memory Medical announced that its Impede embolization plug product family has received certification as a Class III device under the European Union (EU) Medical Device Regulation (MDR) 2017 The Impede devices, previously CE-marked under the Medical Device Directive 93/42/EEC…
Shape Memory Medical announces midway milestone in AAA-SHAPE randomised controlled pivotal trial
Shape Memory Medical has reached 50 per cent enrolment in its ongoing AAA-SHAPE pivotal trial, the company announced last week. AAA-SHAPE is a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to improve…
Shape Memory Medical announces first patient treated in the AAA-SHAPE randomised controlled pivotal trial
Shape Memory Medical recently announced that the first patient has been treated in the AAA-SHAPE pivotal trial. AAA-SHAPE (Abdominal aortic aneurysm sac healing and prevention of expansion) is a prospective, multicentre, randomised, open-label trial to determine safety and effectiveness of…
FDA clears AAA-SHAPE trial for IDE approval
Shape Memory Medical recently announced that the Food and Drug Administration (FDA) has granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill device to…
Shape Memory Medical completes enrollment in the AAA-SHAPE early feasibility study
Shape Memory Medical has announced the completion of patient enrollment in AAA-SHAPE, 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 AAA-SHAPE…
First patient enrolled in AAA-SHAPE Netherlands study
Shape Memory Medical has 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…