Shape Memory Medical Announces IMPEDE Embolization Plug Study Results

Shape Memory Medical Inc. is sharing results from a prospective, open-label, single-arm, safety study of the IMPEDE Embolization Plug in peripheral vascular embolization. The study was published in the peer-reviewed journal Vascular.
 
“We would like to congratulate the investigators and clinical research team at Auckland City Hospital for completing the study and retrospective review of follow-up imaging. The publication is a significant milestone for the company as we continue to evaluate the potential of shape memory polymer and specifically the IMPEDE Embolization Plug family in a variety of arterial and venous applications,” Shape Memory Medical CEO Ted Ruppel said.
 
Both the IMPEDE and IMPEDE-FX Embolization Plugs incorporate shape memory polymer (“smart” polymer), a porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood for acute thrombosis and occlusion. The material is highly conformable and able to accommodate irregular surfaces with low chronic outward force. Shape memory polymer has also been shown in pre-clinical studies to be fully bioresorbable, over time, with collagen formation and fibrosis and without chronic inflammation.
 
The safety study was registered with the Australian New Zealand Clinical Trials Registry and procedures were performed from August 2017 through December 2019. Embolized peripheral vascular vessels include inferior mesenteric arteries, testicular veins to treat varicoceles, internal iliac, renal accessory, and left subclavian arteries to treat or prevent endoleaks, and a profunda branch prior to tumor resection and hemiarthroplasty. Acute technical success of target vessel embolization was achieved in all implantation cases, and no serious adverse events related to the study device occurred. No recurrent clinical symptoms attributable to treated vessel embolization or recanalization were documented through 30-day follow-up.
 
A retrospective review of follow-up imaging through a mean of 22.2 months (range, <1–44 months) was performed post-procedure. “We have been impressed with the performance and durability of the IMPEDE devices which did not show any evidence of recanalization through long-term imaging follow-up,” said Andrew Holden, principal investigator and director of Interventional Radiology at Auckland City Hospital. “The tissue ingrowth into the device is intriguing, and the clinical advantages of this property may emerge in further studies,” stated Professor Holden. “We look forward to seeing how shape memory polymer in clinical practice continues to evolve.”
 
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 European Union. 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.