There’s a new option in balloon-implanted radiation delivery devices for breast cancer patients. The FDA has just allowed SenoRX to market its post-lumpectomy radiotherapy device in the US. From Reuters:
SenoRX said it plans to ship the Multi-Lumen Radiation Balloon Applicator, which is the only multi-lumen balloon device approved for brachytherapy following breast cancer surgery, for post-clearance human clinical trials in the second half of this year, with a full launch expected in early 2008.
“The approval came at least a month, if not two months, earlier than our expectations. This is a positive event and frankly a favorable timing of the event,” Jason Mills, an analyst with Canaccord Adams, said by phone….
…The device is used to provide radiation treatment following lumpectomy for breast cancer. The radiation balloon uses vacuum to remove excess fluid and to adhere closely to often irregularly shaped lumpectomy cavities to deliver precise radiation dosing through multiple seed lumens.
Here’s some lofty language from a SenoRX spokesperson:
“We are excited at the prospect that our radiation balloon product may actually expand the balloon market,” said Lloyd Malchow, SenoRx President and Chief Executive Officer. “Certain patients who are presently candidates for balloon therapy are currently excluded because of the location of the lesion relative to their breast size. Our multi-lumen approach offers a solution to this problem.”