Next generation IUD Intrauterine Ball IUB™ Ballerine launched

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Consilient Health is launching the next generation IUD, an innovative Intrauterine Ball, IUB™ Ballerine®, a well-tolerated4, hormone free, long-lasting reversible contraceptive.

The IUB™ Ballerine® is a novel copper coil and is comprised of copper beads with a total exposed copper surface of 300mm² strung on a flexible Nitinol (nickel/titanium alloy), PET- coated frame. Prior to insertion it is loaded in linear form into a 3.2mm diameter insertion tube and introduced into the uterus by using a push rod. As the IUB™ is released from the insertion tube into the uterus it coils into a spherical shape. Pure elemental copper is incorporated as an ancillary active substance. A monofilament blue polypropylene double tail thread (up to 20cm long) is attached to one end of the IUB frame to aid detection and removal of the device.5

The IUB™ Ballerine® has a unique three-dimensional ball like structure which means:

  1. The IUB™ Ballerine® is designed to adapt to the uterus, while being large enough and voluminous not to pass through the cervix internal os, thereby reducing the probability of expulsion6.
  2. During insertion – the tip of the IUB™ Ballerine® turns 180 degrees as it exits the insertion tube, away from the uterine fundus, thereby reducing the risk of fundal perforation during insertion4.
  3. Malpositioning within the uterine cavity, including rotation or embedment in the myometrium, is reduced through the unique symmetric spherical shape of the IUB™ Ballerine®4.
  4. The IUB™ Ballerine® uses the thinnest insertion tube currently on the market7, at only 3.2mm in diameter.

Commenting on the launch, women’s health expert, Deirdre Lundy said: “This is an innovative and welcome development in IUCD contraception. Unlike traditional framed IUCD, this device comprises a thin length of ‘Nitinol’ wire with 17 tiny copper beads along its length. The tensile wire is stretched straight inside a very slim introducing tube. Once the tube and device are placed at the fundus of the womb, the tube is gently removed and the tensile wire rolls up into a little ball – adapting to the shape of the intrauterine cavity. The copper beads provide contraception for 5 years. Placement should be much kinder as the width of the introducing tube is significantly slimmer than that employed by typical IUCDs.”

IUB™ Ballerine® is GMS reimbursable and covered under the Free Contraception Scheme.

 

  1. Baram I, et Contraception. 2014.
  2. Kurz KH (1984) Cavimeter uterine measurements and IUD clinical correlation. In: Zatuchni GI, Goldsmith A, Sciarra JJ, Intrauterine Contraception: Advances and Future Prospects. Philadelphia: Harper and Row, 142–162.
  3. Bastidas, J. M. et al., 2019. Copper and Nickel Release Kinetics Determination of CU- IUDS in Simulated Uterine Fluid.  National Centre for Metallurgical Research (CENIM), p 16.
  4. Real world safety & performance data for IUB™ Ballerine, OCON Medical Ltd.
  5. Ballerine IFU
  6. Baram et al, 2019
  7. FSRH Clinical Guideline: Intrauterine Contraception (April 2015, amended September 2019).

 

IE-CH-1095, Date of preparation December 2022.