Endoleak

SANTA CLARA, Calif.--( BUSINESS WIRE )--Shape Memory Medical Inc., developer of shape memory polymer for peripheral and neurovascular markets, announced 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. Ted Ruppel, President and Chief Executive Officer of Shape Memory Medical Inc. said, “We would like to congratulate Professor 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.” The EMBO-Post Market Surveillance Registry (EMBO-PMS) initiated at two centers in the United Kingdom and has now expanded to include up to ten 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 Professor 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, UK 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,” continued Morgan. Preliminary experience in EMBO-PMS is published in CVIR Endovascular 2021 Mar 9;4(1):29. About Shape Memory Medical Shape Memory Medical Inc. is dedicated to developing innovative 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. For more information, visit www.shapemem.com .

Medtronic (NYSE:MDT) announced today that it issued a voluntary recall of unused Valiant Navion thoracic stent graft systems. Fridley, Minn.-based Medtronic’s global recall included informing physicians to immediately cease use of the device until further notice, according to a news release. The company initiated the recall in response to information it recently obtained from the Valiant Evo global clinical trial which indicated that three patients in the trial experienced stent fractures, with two of which being confirmed type IIIb endoleaks. One patient death was reported. A Medtronic spokesperson told MassDevice that a secondary reintervention was performed to treat the type IIIb endoleak. Three days after the secondary procedure, the patient experienced hypotension and died. In the absence of an autopsy or explant, the mortality was reported as a probable aortic rupture and adjudicated by the trial’s independent clinical events committee as aneurysm-related mortality because it occurred within 30 days of the secondary procedure. Upon learning of the observations, an independent imaging laboratory reviewed all available images from the patients enrolled in the trial, finding that seven of 87 patients had stent ring enlargement beyond the design specification. Medtronic said those observations require further assessment to determine potential clinical importance. The company is conducting a technical root cause investigation, which includes further review of follow-up clinical trial imaging and commercial complaints and imaging. “There is nothing more important than the safety and well-being of patients,” Medtronic senior VP & president of its structural heart & aortic business Nina Goodheart said in the release. “We treat matters of product safety with the highest priority and urgency. Our decision to implement this voluntary recall is necessary to ensure the utmost patient safety. As our investigation continues, we are committed to timely communication with physicians and regulatory bodies.” This story was updated with additional information surrounding the lone patient death provided by Medtronic.