Edwards Lifesciences' FloTrac sensor approved in Japan

By Lisa Kerner

Erie, Pa., Jan. 25 - Edwards Lifesciences Corp. said it has received regulatory and reimbursement approval from Japan's Ministry of Health, Labor and Welfare for its Edwards FloTrac sensor.

The FloTrac is a minimally invasive heart monitoring device currently commercially available in the United States and Europe, according to a company news release.

Edwards expects to launch the FloTrac sensor for commercial use in Japan in April.

The FloTrac sensor provides continuous cardiac measurements by accessing data directly from an arterial line. These measurements typically include cardiac output, oxygen saturation levels and blood pressure.

FloTrac is less invasive than Edwards' more typically used Swan-Ganz pulmonary artery catheter, the company said.

"We have been working closely with the Central Social Insurance Medical Council, MHLW and some of the country's leading physicians to bring this valuable technology to patients in Japan," Edwards' corporate vice president, Huimin Wang, said in the release.

Edwards Lifesciences focuses on cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company is based in Irvine, Calif.

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