This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: ProstaLund® CoreTherm™
Manufacturer: ProstaLund Operations AB
Address: Höstbruksvägen 10, SE-226 60 Lund, Sweden
US Agent and Distributor: ACMI Corporation
Address: 136 Turnpike Road, Southborough, MA 01772-2104
Approval Date: December 23, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010055a.pdf
What is it? The CoreTherm system is a medical device that uses microwave energy to treat Benign Prostatic Hyperplasia (BPH), a non-cancerous enlargement of the prostate gland that commonly affects men over the age of 50. The prostate is a male reproductive gland that surrounds the urethra and is located at the lower end of the bladder. The CoreTherm device treats the symptoms of BPH by shrinking the prostatic tissue that may be blocking the flow of urine.
The system includes:
- a control unit that comprises hardware and software for microwave delivery and temperature measurements
- a laptop computer with user interface software
- a thin flexible tube (catheter) placed in the urethra during treatment
- an antenna that delivers the heat to the prostate
- temperature probes that measure the temperature in the prostate (for treatment control), in the rectum and on the surface of the penis (as a safety measure) during the treatment
How does the procedure work? Prostate tissue is destroyed by the heat from the microwave source. The device is adjusted to deliver a precise temperature for a specific time period. The operator stops the treatment when an adequate amount of prostate tissue is destroyed, which is usually between 15 and 70 minutes. The patient is awake during the procedure, and healing takes between 6 weeks and 3 months.
When is it used? The method is a non-surgical treatment option for an enlarged prostate.
What will it accomplish? More than 80% of the patients treated with the CoreTherm device in clinical studies responded to the treatment. The major side effects were urinary urgency, urinary retention, urinary tract infection, and hematuria (blood in the urine), generally of short duration.
When should it not be used? This treatment should not be used in patients who:
- have a prostate size on which the CoreTherm system has not been studied.
- have a very narrow urethra preventing easy catheter insertion.
- have an implanted defibrillator, pacemaker, or any other active (electronic) implant, because the microwave energy used in this treatment can interfere with electronic devices.
- have a metal implant in the prostate, pelvis, or hip areas, because the metal could become hot and damage surrounding tissues.
- have a penile implant, because it is unknown if the microwaves could damage the implant.
- have bladder cancer or have had prior radiation therapy to the pelvic region, because this type of therapy has not been studied on men with these conditions.
- want to have children, because changes in ejaculation have been reported after microwave therapy, and the therapy's effect on the body’s ability to make sperm is unknown.
- have active prostatitis (inflammation of the prostate), active urinary tract infection, or peripheral arterial disease with intermittent claudication (leg pain that occurs with walking and disappears with rest), because the effect of the treatment in those patients is not known.
Additional information: Summary of Safety and Effectiveness will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010055