Irvine Scientific, a pioneer in developing products specifically for the
Assisted Reproductive Technology (ART) community, announced today 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.