Tag: AAA-SHAPE
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)...
Shape Memory Medical announces midway milestone in AAA-SHAPE randomised controlled pivotal...
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,...
Shape Memory Medical announces first patient treated in the AAA-SHAPE randomised...
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...
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...
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...
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...