Shape Memory Medical announces publication of results of embolization plug safety study


Shape Memory Medical has announced the publication of results from the company’s prospective, open-label, single-arm, safety study of the IMPEDE embolization plug in peripheral vascular embolization. The study was published this month in the peer-reviewed journal, Vascular, ahead of print.

Ted Ruppel, CEO of Shape Memory Medical said, “We would like to congratulate the investigators and clinical research team at Auckland City Hospital [Auckland, New Zealand] 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.”

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 preclinical 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 (ANZCTR): 12617000906358. Procedures were performed from August 2017 to 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 tumour 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 recanalisation 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 recanalisation 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 Holden. “We look forward to seeing how shape memory polymer in clinical practice continues to evolve.”

‘Shape memory polymer technology in peripheral vascular embolization’ was first published online in Vascular on May 22, 2023 and is available via open access.


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