Irvine Scientific(R) Receives 510(k) Clearance For The Use Of Vit Kit(R)-Freeze And Vit Kit(R)-Thaw With Embryos Of All Stages

Main Category: Fertility
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 Mar 2010 - 17:00 PDT


Irvine Scientific, a pioneer in developing products specifically for the Assisted Reproductive Technology (ART) community, announced that the U.S. Food and Drug Administration (FDA) has approved their products intended for vitrification of pronuclear (PN) zygotes through day 3 cleavage and blastocyst stage embryos within the fertility area.

The approval for both Vit Kit®-Freeze and Vit Kit®-Thaw, joins a long list of industry firsts from Irvine Scientific. This approval now allows users greater flexibility to vitrify specimens depending on the IVF laboratory's protocol and their patients' needs. Vitrification has enabled clinics to improve pregnancy rates over those of traditional slow cooling and also to move toward practicing Single Embryo Transfers when possible to reduce multiple pregnancies, and improve lab efficiency.

"We are pleased to be the first, and to-date, the only company that offers superior quality vitrification solutions for cryopreservation of all stages of embryos (PN through blastocyst stage) in the US. We hope with the addition of the expanded use for Vit Kit®-Freeze and Vit Kit®-Thaw, IVF clinics can offer better patient care," said Tim Mullane, Chief Operating Officer, Irvine Scientific.

Source
Irvine Scientific

• Additional
• References
• Citations