Micro Therapeutics Inc., an Irvine manufacturer of vascular diagnostic and treatment devices, late last month received approval to market its micro catheters in Japan.
The catheters, already approved by the Food and Drug Administration for U.S. distribution last year, deliver therapeutic drugs and other materials intravenously.
Company officials expect strong Japanese sales because of a relatively high rate of liver tumors within Japan’s population and an expected nationwide increase in demand for treatment of this type of tumor, according to president and CEO John Rush.
Micro Therapeutics relies on Tokyo-based Century Medical Inc. to get the product through Japan’s notoriously maze-like distribution channels and into that country’s hospitals.
Century handles all regulatory applications and fees, and was responsible for obtaining Japanese government approval of the product,a process known as shonin, which is the Japanese equivalent of U.S. FDA approval.
The main competition for Micro Therapeutics’ products in Japan will come from Natick, Mass.-based medical-device maker Boston Scientific Corp., according to a Micro spokesman.
Micro Therapeutics plans to follow up the introduction of its micro catheters with a tie-in product, called “Onyx,” designed for delivery into blood vessels through the catheters to treat various types of blood clots and brain disorders associated with strokes.
Onyx has received European approval as well as conditional FDA approval in the U.S. with trials for Japan still in the planning stages. The company expects to begin selling the product in Europe early next year.
Micro Therapeutics develops, manufactures and markets over 80 devices used to diagnose and treat vascular disease. The company, founded in 1993, employs 135 people in Orange County.
