Irvine Scientific, a leading medical device/biotechnology company located in Santa Ana, CA announced that the first vitrification product for blastocysts (day 5 human embryos from an in vitro fertilization procedure) is available in the U.S. after recently receiving clearance from the U.S. Food and Drug Administration. The product, known as Blastocyst Vitrification Kit or Vit Kit™ is the first medical device of its kind to be introduced in the United States following nearly a five year development and regulatory review process.
Vitrification is an innovative technique for cryopreserving oocytes (eggs) and embryos. This new cryopreservation method results in much higher pregnancy rates than conventional methods. Conventional methods utilize slow freezing techniques which involve steps that could lead to the formation of ice crystals in the cells thus causing damage. Vitrification involves dehydrating the cells and very rapidly cooling them in liquid nitrogen, which avoids any ice crystal formation, thereby eliminating the potential for cell damage.
The Vitrification procedure has been widely used in Europe, Japan and South America with outstanding success. The benefits of Vitrification in these countries have already been realized as a means to preserve fertility for cancer patients who wish to freeze their eggs prior to chemotherapy and for young women who wish to postpone pregnancy while they pursue higher education and/or advance their careers. Dr. Masa Kuwayama, Director of the Kato Clinic in Japan has had clinical success with vitrification with over 13,000 procedures.
“We are pleased that we are able to offer an innovative product to fertility clinics that will change the future of reproductive medicine,” stated by Dr. Michael Kelly, Irvine Scientific President and CEO.
Irvine Scientific which has provided IVF products to the medical community for over thirty years is located in Santa Ana, California and is a subsidiary of Japan Energy Corporation.
Revision date: July 8, 2011
Last revised: by Janet A. Staessen, MD, PhD