Prolieve™ - P030006
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: Prolieve™
Manufacturer: Celsion Corporation
Address: 10220-L Old Columbia Road, Columbia, Maryland 21046-2364
Approval Date: February 19, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030006a.pdf
What is it? Prolieve™ is a transurethral microwave therapy (thermodilalation) system 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 Prolieve™ device treats the symptoms of BPH by compressing and heating prostatic tissue that may be blocking the flow of urine.
Prolieve™ consists of a permanent instrument and a single-use procedure kit.
The permanent instrument:
- generates the microwave power,
- provides temperature-controlled water circulation,
- monitors treatment parameters, and
- records treatment data.
The single-use procedure kit is used with the permanent instrument and consists of:
- a microwave transurethral catheter with retention and compression balloons,
- a heat exchanger cartridge system, and
- a 500 mL bag of sterile water.
How does it work? Prolieve™ delivers microwave energy to the prostate with simultaneous balloon-administered compression (thermodilatation) for 45 minutes. The microwave energy heats the prostate to a temperature between 44?C and 46?C, while the catheter balloon administers compression to the prostate over a treatment length of 1.2 to 5.5cm.
When is it used? Prolieve™ is used to provide a non-surgical, minimally invasive treatment of symptomatic BPH in men with a prostate volume of 20 to 80 grams, and in whom drug therapy (e.g., Proscar®) is typically indicated.
What will it accomplish?
- Prolieve™ will reduce the primary symptoms of BPH that include incomplete bladder emptying, high frequency of urination, urinary intermittency, urgency, a weak stream, straining to urinate and excessive urination at night (nocturia).
- Prolieve™ has also demonstrated an ability to improve peak flow rate, quality of life, post-residual volume, and other disorders associated with urination.
Study results show the effectiveness of the Prolieve™ in males with prostate sizes from 20 to 80 grams and lengths of 1.2 to 5.5cm. The effectiveness of Prolieve™ for other demographic groups and beyond approximately 12 months has not been determined.
When should it not be used? This treatment should not be used in patients who have:
- a prostate size on which the Prolieve™ system has not been studied,
- a very narrow urethra preventing easy catheter insertion,
- an implanted defibrillator, pacemaker, or any other active (electronic) implant, because the microwave energy used in this treatment can interfere with electronic devices,
- a metal implant in the prostate, pelvis, or hip areas, because the metal could become hot and damage surrounding tissues,
- a penile implant, because it is unknown if the microwaves could damage the implant,
- 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,
- a desire 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, or
- active inflammation of the prostate (prostatitis), active urinary tract infection, or peripheral arterial disease with intermittent leg pain that occurs with walking and disappears with rest (claudication), because the effect of the treatment in those patients is not known.
Additional information: Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030006