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 registry study of its Impede and Impede-FX embolisation plugs when used for peripheral vascular embolisation.
The patient was treated by Götz Martin Richter, chairman of the Clinics for Diagnostic and Interventional Radiology at the Center for Minimally Invasive Medicine, Klinikum Stuttgart (Stuttgart, Germany) in cooperation with the Clinic for Vascular Surgery, Endovascular Medicine and Transplant Surgery in the Klinikum Stuttgart.
The EMBO-PMS has been initiated at two centres in the UK and has now expanded to include up to ten centres in Germany, with the goal of treating up to 125 patients. Results thus far in the UK reflect treatment for conditions including iliac artery aneurysm, type II endoleak after thoracic endovascular aneurysm repair (TEVAR), type 1b endoleak after endovascular aneurysm repair (EVAR), gluteal artery aneurysm, and splenomegaly. “We are pleased to participate in this important study and look forward to the follow-up from our treated patients,” said Richter, who is also the principal investigator for the EMBO-PMS.
Both the Impede and Impede-FX embolisation plugs incorporate Shape Memory Medical’s shape memory polymer, which is a porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood, enabling conversion to organised thrombus followed by gradual healthy tissue formation. Preclinical and clinical studies have shown that shape memory polymer offers effective and predictable space filling, stable clot formation for embolisation, and progressive healing as the material is absorbed.
“We look forward to collaborating with colleagues from Germany to add to the experience within EMBO-PMS,” said Robert Morgan, consultant vascular and interventional radiologist, St George’s NHS Trust (London, UK) and principal investigator, EMBO-PMS UK registry. “We are continuing to obtain data to support the safety and effectiveness of the Impede devices across a variety of peripheral vascular anatomies with technical success and target vessel thrombosis achieved in all cases,” continued Morgan.