WILMINGTON, Mass., April 25 /PRNewswire-FirstCall/ -- CardioTech International, Inc. today announced that its wholly owned subsidiary, Gish Biomedical Inc. (“Gish”) has received Japanese clearance to sell its Stat-Sat oxygen saturation monitor that measures venous and arterial oxygen saturation, hematocrit and hemoglobin in-line, as well as its disposable arterial filter that separates air from blood and filters particles from the circuit during bypass surgery.
The Japanese medical device market is among the worlds most lucrative, while requiring the most stringent quality standards. Approximately 48,000 cardiac surgery procedures are conducted annually in Japan, representing an important export market for Gish.
Douglas E. Whittaker, President of Gish stated, “We are very pleased to announce that Heiwa Bussan, our distributor in Japan, has received regulatory clearance to sell the Gish Stat-Sat Oxy-Sat Monitor and Gish Arterial Filter products in the Japanese market. We worked very closely with Heiwa Bussan to gain clearance from Japan’s Ministry of Health, Japan’s equivalent to the American FDA. I expect this clearance to add to our revenues and profits, since the Japanese market is among the most lucrative in the world.”
The principle of the heart-lung machine (also known as cardiopulmonary bypass) is a marvel of modern biomedical technology. Venous blood withdrawn from the patient is drained into a reservoir. From there the blood is pumped through an oxygenator. Oxygen is delivered at the interface between the blood and the device, permitting the red blood cells to absorb oxygen molecules directly. Finally, the heart-lung machine pumps the newly oxygenated blood back into the patient through a tube connected to the arterial circulation. During this process, which may take several hours, the blood is continually watched with the Gish Stat-Sat in-line monitor, and the Gish arterial filter is used to return de-aerated and microfiltered blood to the patient.
CardioTech believes that this Release contains forward-looking statements that are subject to risks and uncertainties. Such statements are based on management’s current expectations and are subject to factors that could differ materially from the forward-looking statements. Please refer to CardioTech’s SEC filings.
For more information, please contact: Michael Szycher, Ph.D. CEO (978) 675 0075
CardioTech International, Inc.
CONTACT: Michael Szycher, Ph.D., CEO of CardioTech, +1-978-675-0075
Web site: http://www.cardiotech-inc.com/
