Shape Memory Medical’s EMBO-PMS Registry of Impede Devices Expands to Germany

February 22, 2023—Shape Memory Medical Inc., a developer of a shape memory polymer for peripheral and neurovascular applications, announced the first patient enrollment in Germany in the company’s EMBO-PMS registry.

According to Shape Memory Medical, the EMBO-PMS registry is a prospective, multicenter study of the company’s Impede and Impede-FX embolization plugs used for peripheral vascular embolization. The registry was initiated at two centers in the United Kingdom and has now expanded to include up to 10 centers in Germany with a goal of treating up to 125 patients.

Professor Götz Martin Richter, MD, Chairman of the Clinics for Diagnostic and Interventional Radiology at the Center for Minimally Invasive Medicine, Klinikum Stuttgart, treated the initial patient in Germany in cooperation with the Clinic for Vascular Surgery, Endovascular Medicine, and Transplant Surgery in the Klinikum Stuttgart in Stuttgart, Germany.

Prof. Richter, who serves as Principal Investigator for the EMBO-PMS German registry, commented in the company’s press release, “We are pleased to participate in this important study and look forward to the follow-up from our treated patients.”

Thus far, the company noted, results in the United Kingdom reflect treatment for conditions including iliac artery aneurysm, type II endoleak after thoracic endovascular aortic repair, type Ib endoleak after endovascular aneurysm repair, gluteal artery aneurysm, and splenomegaly.

In March 2021, preliminary experience in EMBO-PMS was published by Professor Robert A. Morgan, MD, et al online in the Cardiovascular and Interventional Radiological Society of Europe’s journal, CVIR Endovascular.

Prof. Morgan, who is a consultant vascular and interventional radiologist with St. George’s NHS Trust in London, United Kingdom, serves as Principal Investigator of the EMBO-PMS United Kingdom registry.

“We look forward to collaborating with colleagues from Germany to add to the experience within EMBO-PMS,” stated Prof. Morgan in Shape Memory Medical’s press release. “We’re 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.”

Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical, added, “We would like to congratulate Prof. Richter and the clinical study team at Klinikum Stuttgart for the first EMBO-PMS case in Germany. The addition of German sites accelerates our ability to evaluate the Impede and Impede-FX embolization plugs in a variety of uses within the peripheral vasculature.”

Shape Memory Medical’s Impede and Impede-FX embolization plugs incorporate the company’s shape memory polymer. The polymer is a porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self expands on contact with blood, enabling conversion to organized 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 embolization, and progressive healing as the material is absorbed, stated the company.

The Impede and Impede-FX embolization plugs, as well as the Impede-FX RapidFill device, have received CE Mark approval, with the indication 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. Additionally, the Impede and Impede-FX embolization plugs have regulatory approval in Japan.