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FDA clears brachytherapy breast irradiation device

standardizing the procedure and enhancing the accuracy of high dose-rate breast brachytherapy, the company said, the device a

Last Updated: 2002-10-08 17:25:54 -0400 (Reuters Health)

WASHINGTON (Reuters Health) - Nucletron Corporation, the US subsidiary of Netherlands's Delft Instruments BV, said on Tuesday that the US Food and Drug Administration (FDA) cleared its Kuske Breast Template, a device designed to guide physicians during interstitial accelerated partial breast irradiation (APBI) procedures.

One method of delivering APBI is through brachytherapy. According to Nucletron, the Kuske Breast Template physically holds the breast in place and provides a navigational guide in conjunction with diagnostic imaging to direct the multiple insertions around the site of the recently removed tumor.


The device was developed Dr. Robert Kuske, Jr., of the University of Wisconsin, Nucletron said.

The company added that long-term follow-up from Dr. Kuske's original studies using the breast template showed less than a 2% local recurrence rate in nearly 300 women treated over eleven years.

The Kuske Template will allow more physicians to "offer an effective treatment option in less time," said Nucletron US president Jack Coats in a statement.

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