Irvine Scientific Receives FDA 510(k) Clearance
News May 10, 2016
Irvine Scientific has announced the receipt of FDA 510(k) clearance for expanded use of Vit Kit® vitrification media to include human oocytes. The company is the first, and only company to date, to obtain 510(k) clearance of vitrification media for use with oocytes within the US. Irvine Scientific’s Vit Kit-Freeze and Vit Kit-Thaw are now intended for worldwide use with oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Vitrification is a cryopreservation technique that provides excellent survivability of embryos and oocytes through dehydration and ultra-rapid cooling. This process eliminates the concerns of damaging ice-crystal formation associated with traditional slow freezing. The ability to offer an FDA-cleared vitrification media for oocytes will enhance the ability of fertility clinics to preserve women’s fertility through oocyte freezing.
Egg freezing offers women the choice to preserve healthy eggs before undergoing cancer treatment, chemotherapy or radiation therapy which compromise ovarian function and egg viability. Age negatively impacts a woman’s egg supply in both quality and quantity, so freezing eggs while young is also an option for those who wish to delay starting a family.
“We are very pleased to be the first and only company to offer vitrification media cleared by the FDA for use with oocytes in the US,” said Timothy P. Mullane, Chief Operating Officer, Irvine Scientific. “It represents our commitment to supplying the best quality products to laboratories, and to support their need for an effective, regulated means to preserve fertility and help patients achieve their hopes for having healthy babies in the future.”
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