Tag: Shape Memory Medical
MDR certification secured for Impede embolization plug devices
Shape Memory Medical announced that its Impede embolizationisation plug product family has received certification as a Class III device under the European Union (EU)...
Shape Memory Medical completes enrolment in EMBO-PMS registry
Shape Memory Medical today announced the completion of patient enrolment in the EMBO postmarket surveillance (EMBO-PMS) registry, the company’s prospective, multicentre registry of the...
One-year results from AAA-SHAPE trial to be presented at VEITH 2023
Shape Memory Medical, developer of custom shape memory polymers for endovascular markets, announced that one-year data from the AAA-SHAPE safety trial will be presented...
Shape Memory Medical announces first patient treated in EMBO postmarket surveillance...
Shape Memory Medical has announced the first patient treated in Germany as part of the EMBO postmarket surveillance registry (EMBO-PMS), the company’s prospective, multicentre...
Shape Memory Medical celebrates treatment of 1,500th patient
Shape Memory Medical announced today that its 1,500th patient has been treated, marking a significant milestone for the company’s portfolio of shape memory polymer...
First patient enrolled in Shape Memory Medical’s AAA-SHAPE Netherlands study
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...
Shape Memory Medical receives PMDA approval for the Impede-FX embolisation plug
Shape Memory Medical recently announced that it has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to market its Impede-FX embolisation...
FDA clears Shape Memory Medical’s Impede-FX embolization plug
The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Impede-FX embolization plug (Shape Memory Medical). This device is available in...
