First Patient Treated in EMBO-Post Market Surveillance Registry in Germany

Shape Memory Medical Inc. has treated the first patient treated in Germany as part of the EMBO-Post Market Surveillance Registry, the company’s prospective, multicenter, registry study of its IMPEDE and IMPEDE-FX Embolization Plugs when used for peripheral vascular embolization.
 
The patient was treated by Professor Dr. Götz Martin Richter, chairman of the Clinics for Diagnostic and Interventional Radiology at the Center for Minimally Invasive Medicine, Klinikum Stuttgart, Germany, in cooperation with the Clinic for Vascular Surgery, Endovascular Medicine and Transplant Surgery in the Klinikum Stuttgart.

“We would like to congratulate Professor Richter and the clinical study team at Klinikum Stuttgart for the first EMBO-PMS case in Germany,” Shape Memory Medical President/CEO Ted Ruppel said. “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.”
 
The EMBO-Post Market Surveillance Registry (EMBO-PMS) began 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. Results thus far in the United Kingdom reflect treatment for conditions including Iliac artery aneurysm, type II endoleak after TEVAR, type Ib endoleak after 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, principal investigator for EMBO-Post Market Surveillance German Registry.
 
Both the IMPEDE and IMPEDE-FX Embolization Plugs incorporate Shape Memory Medical’s novel shape memory polymer, a porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood, that enables conversion to organized thrombus followed by gradual healthy tissue formation. Pre-clinical 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.
 
“We look forward to collaborating with colleagues from Germany to add to the experience within EMBO-PMS,” said Professor Robert Morgan, Consultant Vascular and Interventional radiologist, St. George’s NHS Trust, London, U.K., and principal investigator, EMBO-Post Market Surveillance UK Registry. “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.”

Shape Memory Medical Inc. develops therapeutic solutions with its proprietary shape memory polymers. Neurovascular embolization products include the TrelliX Embolic Coil, which is CE marked for use in the EU. Peripheral embolization products include the IMPEDE and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill Device. In countries recognizing CE marking, the IMPEDE and IMPEDE-FX Embolization Plugs and the IMPEDE-FX RapidFill are indicated 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. The IMPEDE and IMPEDE-FX Embolization Plugs are PMDA approved in Japan. The TrelliX Embolic Coil and IMPEDE-FX RapidFill Device are not available in the United States or Japan.