Vitrolife gets U.S. approval for embryo transfer catheter

By E. Janene Geiss

Philadelphia, Feb. 14 - Vitrolife said Tuesday that through its newly acquired subsidiary, Swemed, it has obtained approval from the Food and Drug Administration to begin marketing and sales of a product for the introduction of an embryo into the uterus after in vitro fertilization called ClearVision Embryo Transfer Catheter.

"With the approval, the product range of medical instruments and solutions for in vitro fertilization is complete, which means greater customer benefit and market potential," Magnus Nilsson, chief executive officer of Vitrolife, said in the release.

ClearVision ETC is a medical instrument that is used to introduce the embryo into the uterus. The transfer of the embryo constitutes the last stage of in vitro fertilization and is a critical step in the process.

In recent years it has been shown that the properties of the embryo transfer catheters together with simultaneous use of ultrasound can improve pregnancy frequency, officials said.

ClearVision ETC is designed with input from leading Swedish in vitro fertilization clinics to meet the market's high quality requirements. The product can be used with or without ultrasound, officials said.

It is estimated that about 600,000 in vitro fertilizations are carried out per year in the world and that the total market value for ClearVision ETC amounts to about SEK 140 million.

Vitrolife is a Kungsbacka, Sweden, biotechnology/medical device group that works with developing, manufacturing and selling advanced products and systems for the preparation, cultivation and storage of human cells, tissue and organs.

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