Shape Memory Medical’s Impede Embolization Plug Evaluated in Published Safety Study

May 30, 2023—Shape Memory Medical Inc., which develops shape memory polymer for peripheral and neurovascular applications, announced the publication of results from the company’s safety study of the Impede embolization plug in peripheral vascular embolization. The prospective, open-label, single-arm study was published online ahead of print by Professor Andrew Holden, MBChB, et al in Vascular.

According to the company, procedures in the study were performed from August 2017 through December 2019. Embolized peripheral vascular vessels included inferior mesenteric arteries, testicular veins to treat varicoceles, internal iliac, renal accessory, left subclavian arteries to treat or prevent endoleaks, and a profunda branch before tumor resection and hemiarthroplasty. The study was registered with the Australian New Zealand Clinical Trials Registry (#12617000906358).

The company reported the study found the following:

• Acute technical success of target vessel embolization was achieved in all implantation procedures.
• There were no serious adverse events related to the study device.
• No recurrent clinical symptoms attributable to treated vessel embolization or recanalization were documented through 30-day follow-up.

Additionally, a retrospective review of follow-up imaging through a mean of 22.2 months (range, < 1-44 months) was performed post procedure.

Prof. Holden, who serves as Principal Investigator of the study, is Director of Interventional Radiology at Auckland City Hospital in Auckland, New Zealand.

“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,” commented Prof. Holden in the company’s press release. “The tissue ingrowth into the device is intriguing, and the clinical advantages of this property may emerge in further studies.”

Prof. Holden added, “We look forward to seeing how shape memory polymer in clinical practice continues to evolve.”

Shape Memory Medical’s Impede and Impede-FX embolization plugs incorporate shape memory polymer—or “smart” polymer—to provide a porous, radiolucent, embolic scaffold. The scaffold is crimped for catheter delivery and self-expands upon contact with blood for acute thrombosis and occlusion. The highly conformable material is 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, stated the company.

The Impede and Impede-FX embolization plugs as well as the Impede-FX RapidFill device have received CE Mark approval and 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; 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 are also approved in Japan. The Impede-FX RapidFill device is not available in the United States or Japan, advised the company.