Shape Memory’s Impede Embolization Plug Family Approved in Brazil

October 6, 2026—Shape Memory Medical Inc. announced that Brazil’s national health surveillance agency, ANVISA (Agência Nacional de Vigilância Sanitária), has granted authorization for the Impede embolization plug, the Impede-FX embolization plug, and the Impede-FX RapidFill.

In Brazil, the three devices are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The company noted that the approval process was supported by Biomedical, which acts as Shape Memory Medical’s Brazilian registration holder for its peripheral embolization product line.

According to Shape Memory, the Impede embolization plug product family incorporates Shape Memory Medical’s novel shape memory polymer, a radiolucent and highly porous material designed for catheter-based delivery.

The Impede and Impede-FX embolization plugs are available in three sizes, with the largest device offering an expanded diameter of 12 mm and an embolic volume capacity of 1.25 mL. The Impede-FX RapidFill offers up to 6.25 mL of expanded embolic volume to provide a versatile solution for embolization procedures across a wide range of peripheral vessels.

The safety and effectiveness of the company’s shape memory polymer solutions in peripheral embolization have been demonstrated in multiple peer-reviewed studies.

In Europe, the Impede and Impede-FX embolization plugs and Impede-FX RapidFill have received CE Mark approval. Additionally, the Impede and Impede-FX embolization plugs are approved for use in Japan.

In the United States, Impede and Impede-FX are cleared for use. 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-FX RapidFill is an investigational device, limited by Federal law to investigational use in the United States.