Intrauterine Ball SCu300

Alternative Name: SCu300 Intrauterine Devices, empira™

Description: A shape-memory alloy wire threaded through a series of copper spheres. The wire is straight when in applicator, and curls into a three-dimensional ball once released from the inserter and into the uterus. This product has 300mm2 of copper. Three size variants, A, B, and C, range from 12 mm to 18 mm in diameter.

Product Details

User: Female

Hormonal: No

Delivery Method: Intrauterine

Duration Type: Long-acting

Duration: 5 years

Dose: 300mm2

Active Pharmaceutical Ingredient (API):
  • copper

Inactive material: Nitinol (nickel and titanium composite material) wire

Multipurpose Preventive Technology (MPT): No

Status Details

Developer: OCON Medical Ltd.

Project Phase: Limited Market Availability

Development Stage: SRA/WHO PQ Approved

Began discovery in: 2008

Active Development: Yes

Status Details:
  • The SCu300A product received a CE mark in June 2014, while the SCu300B variant received a CE mark in December 2014. The produce is currently marketed in Israel, Austria, Germany, Switzerland, and is expanding through more broadly in Europe and globally. As of 2018, 60,000 devices have been sold.
  • Full data from a randomized study comparing the IUB 300 the TCu380A were expected to be published in 2018, but study ended up being withdrawn. Interim data published in 2016.
  • The empira™ is based on the IUB™ SCu300, designed for developing regions to be provided via international organizations.

Additional Information

References:

Footnotes:
  • There is also an Intrauterine Ball with 380mm2 of copper. Development of this product has been canceled.

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