Shape Memory Medical announced on October 6, 2026 that Brazil’s health regulator, ANVISA, has authorized three devices in its IMPEDE embolization plug family: IMPEDE, IMPEDE-FX and IMPEDE-FX RapidFill. The company’s own clearance list maps two Brazilian registration numbers to the three products. The public material does not say when the registrations were published, who holds them, or whether the devices can already be bought by Brazilian hospitals.
What was authorized
A Business Wire announcement, as reproduced on a news page, says ANVISA authorized all three devices and that Biomedical supported the authorization process. Treat this as a manufacturer-reported authorization. We did not retrieve ANVISA’s own product records.
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| Product | Brazil ANVISA number (per Shape Memory Medical) |
|---|---|
| IMPEDE Embolization Plug | 10256400088 |
| IMPEDE-FX Embolization Plug | 10256400089 |
| IMPEDE-FX RapidFill | 10256400089 |
The numbers come from the company’s current product-clearance page, accessed October 7, 2026. That page lists IMPEDE-FX and RapidFill as separate products under one shared number. It doesn’t explain the grouping. It also doesn’t show that the two have identical indications.
What the IMPEDE plug is
Shape Memory Medical describes the IMPEDE Embolization Plug as a device made from a “novel smart polymer”, supported by an anchor coil for stability. The company says it fills space and conforms to the anatomy. Those are manufacturer descriptions, not independently demonstrated outcomes.
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The company’s stated indication reads: “The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.” That wording is for the IMPEDE plug. The sources don’t show that the same text applies to IMPEDE-FX or RapidFill in Brazil, or that it matches the Portuguese labeling ANVISA approved.
How Brazilian authorization works
ANVISA’s medical-device guidance (modified May 16, 2026) says marketing authorizations for Class III and IV devices are called registro. They are valid for ten years from publication in Brazil’s Federal Official Gazette and can be renewed for equal periods. The guidance also says a foreign manufacturer needs a legally constituted partner company in Brazil. That partner is responsible for products imported and distributed there.
These are general rules. The IMPEDE family’s risk class, its publication dates and its renewal dates aren’t documented in the material available, so no ten-year expiry can be calculated for these devices.
How this differs from the U.S. clearances
The U.S. FDA database lists the IMPEDE Embolization Plug in 5 mm, 7 mm and 10 mm sizes under 510(k) K181051, with a substantially equivalent decision dated June 22, 2018. It lists IMPEDE-FX under K182390, decided May 23, 2019. These are separate regulatory events. They don’t establish what Brazil approved in terms of sizes, indications or labeling.
What isn’t established yet
- Availability: authorization is not the same as commercial availability. No source confirms a distributor, a sales channel or hospital access in Brazil.
- Registration holder: the holder’s legal name isn’t stated. The announcement names Biomedical only as supporting the process.
- Publication date: the date in the Federal Official Gazette isn’t given.
- Approved indications and class: the full Portuguese-language indications and the device risk class aren’t given.
Clinicians and procurement teams who need those details should check ANVISA’s product registry for each number above, or ask Shape Memory Medical or its Brazilian partner for the approved instructions for use.
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