FDA Approves Urologix Cooled ThermoCath 4.5+ Treatment Catheter; New Catheter and Recent FDA Labeling Changes Expand Treatable BPH Patient Population.
"We developed the Cooled ThermoCath 4.5+ catheter in response to requests from our physician customers," said David A. Montecalvo, Urologix vice president of product development and operations. "This longer length catheter expands the indications for Cooled ThermoTherapy and broadens the patient population that can benefit from our therapy. We are eager to see more patients enjoy lasting relief from BPH with our safe and effective therapy."
The new catheter incorporates a longer antenna for those patients with longer urethral lengths, thus requiring increased heating of tissue, and uses Urologix unique Cooled ThermoCath catheter design. The company now offers a full line of catheters to treat patients with prostatic urethral lengths of 2.5 cm and greater. This product requires no changes in physician use beyond patient selection and a software upgrade.
Urologix has also gained recent FDA approvals for expanding the patients eligible for Cooled ThermoTherapy treatment. Some BPH patients are unable to void and therefore rely on a catheter to empty their bladder, a condition known as retention. These retention patients are now able to be treated with Urologix Cooled ThermoTherapy. Until this recent FDA approval, these patients have had only one option - a surgical procedure. Urologix also gained FDA approval to remove the contraindication of treating patients who wear Defibrillators or Pacemakers (2.6 inches or greater from the urethra). In addition, patients with a prostatic condition referred to as "Median Lobe" are now able to be treated with Cooled ThermoTherapy with a precaution for only those patients with a specific "Ball Valve" type of Median Lobe.
Fred B. Parks, Urologix Chairman and Chief Executive Officer commented, "This recent new product approval, in addition to the FDA labeling expansion approvals, caps a very active six month period in which we have made significant progress toward our goal of providing our Cooled ThermoTherapy to a wider range of BPH patients."
BPH, also known as enlarged prostate disease, is a non-cancerous condition in which prostate cells begin to increase in number. This growth, a normal part of aging process, causes the gland to compress the urethra making urination difficult or painful. Although it is not known exactly what causes an enlarged prostate, it is a common condition generally affecting men over age 50. In fact, more than half of all men over age 60 have BPH symptoms. If left untreated, BPH can lead to more serious health problems, such as urinary retention, bladder stones, urinary infections or kidney damage.
Urologix, Inc., based in Minneapolis, develops, manufactures and markets minimally invasive medical products for the treatment of urological disorders. The company has developed and offers non-surgical, anesthesia-free, catheter-based treatments that use a proprietary cooled microwave technology for the treatment of benign prostatic hyperplasia (BPH), a condition that affects more than 23 million men worldwide. Urologix markets its products under the Targis(R) and Prostatron(R) names. Both systems utilize Cooled ThermoTherapy(TM) - targeted microwave energy combined with a unique cooling mechanism to protect healthy tissue and enhance patient comfort - and provide safe, effective, lasting relief of the symptoms of BPH.
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|Date:||Jul 13, 2005|
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