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Irvine Scientific Receives 510(k) Clearance for the use of Vit Kit(R)-Freeze and Vit Kit(R)-Thaw with Embryos of all Stages


3/16/2010 6:49:57 AM

SANTA ANA, Calif.--(BUSINESS WIRE)--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.

About Irvine Scientific:

Irvine Scientific, a subsidiary of Japan Energy Corporation, is a worldwide leader in the design, manufacture and distribution of medical devices, including Industrial Cell Culture, Cytogenetic, and Assisted Reproductive Technology (ART) products. Irvine Scientific is a large scale producer of advanced and quality cell culture media for the industrial bioprocess and diagnostic markets. The company has extensive experience in the design of culture media leading to significant improvements in biopharmaceutical yield. The company also manufactures media for the medical and stem cell applications.

Irvine Scientific’s worldwide distribution channels deliver products to large scale biopharmaceutical industry and to the research and laboratory communities.

Contact:

Irvine Scientific Kiersten Carlin 1-949-261-7800 tmrequest@irvinesci.com

Read at BioSpace.com

   

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