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FDA Approves EchoSeed (Iodine-125), New Brachytherapy Implant for Prostate Cancer
LONDON, UK -- June 4, 2001 -- Nycomed Amersham, the world leader in brachytherapy implants for prostate cancer, announced it has received FDA clearance and all other regulatory approvals required in the U.S. to market EchoSeed™ (Iodine-125), a new generation of brachytherapy seed that will maximize patient care.
EchoSeed's patented technology utilizes conventional ultrasound imaging to provide physicians with more information about seed placement during the course of an implant procedure.
"EchoSeed represents the first true breakthrough in brachytherapy treatment since the introduction of RAPID Strand™ in 1995 and will reinforce Nycomed Amersham's leadership position in the U.S.," said John Jeans, President of Nycomed Amersham Imaging's Therapy Products business.
"EchoSeed was developed after feedback from leading practitioners in prostate brachytherapy who wanted more immediate visual information about seed placement during the course of a prostate implant, using currently available imaging technology. Extensive market research among physicians verified EchoSeed's strong market potential," added Mr. Jeans.
EchoSeed's patented grooved design in combination with conventional ultrasound imaging allows the physician to view both the prostate gland and EchoSeed during an implant procedure. The physician is able to see more of the seeds during the implant procedure thus facilitating optimal placement into the prostate. EchoSeed will be launched later today at the American Urological Association Annual Meeting in Anaheim, California.
Prostate brachytherapy, also referred to as seed implantation, is a minimally invasive outpatient procedure in which radioactive seeds are implanted within the prostate, where they irradiate the tumor. For example, OncoSeed seeds are tiny pellets about the size of a rice grain, consisting of a titanium capsule containing silver wire adsorbed with radioactive iodine. Within days following the procedure, most patients are back to their everyday activities. The seeds irradiate the tumor from within while leaving the patient whole, and having a minimal effect on neighboring organs such as the rectum and bladder.
The use of Nycomed Amersham's OncoSeed for treatment of early stage prostate cancer has risen dramatically in recent years, as the efficacy and low side effect profile of this form of brachytherapy have become better known in the United States.
Results of a twelve-year study using OncoSeed reaffirmed disease-free survival rates reported in an earlier landmark ten-year study. Note: The ten-year data for OncoSeed has been published in peer reviewed scientific literature (Cancer, 1998). The twelve-year data has been presented at the prestigious American Urological Association (AUA).
Other choices for the treatment of prostate cancer, which patients should discuss with their physician, include radical prostatectomy (surgical removal of the prostate) or external beam radiation therapy. The most commonly reported side effect of prostate brachytherapy is short-term obstructive or irritative urinary symptoms in the first few weeks after treatment. Impotence has been reported to occur in 6 percent to 30 percent of cases, significantly less than the rate of impotence reported after radical surgery. Long-term incontinence is uncommon.
SOURCE: Nycomed Amersham
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