A Medical Device Daily
SRS Medical (Redmond, Washington) took advantage of the American Urological Association (AUA; Linthicum, Maryland) conference in Orlando this week to report the "official" U.S. launch of its UroCuff CT 3000, a system designed for non-invasive diagnosis of male bladder function. The device was demonstrated at the conference.
SRS makes equipment for urodynamics, the diagnostic procedures that are the standard of care for patients with lower urinary tract symptoms (LUTS).
"The UroCuff CT 3000 meets a longstanding need for accurate, non-invasive assessment," said CEO Kevin Connolly. "Many men who have been reluctant to undergo the catheterization necessary for conventional urodynamics can now be tested quickly and comfortably. We are proud to be part of such a significant advance in diagnostic technology."
This year, thousands of men over 50 who suffer from LUTS will undergo transurethral resection of the prostate (TURP). This procedure is not without risk, and up to 30% of patients see no change in symptoms following the operation, according to SRS. The UroCuff CT3000 is designed to help identify those patients that have good bladder contractility, yet suffer from Bladder Outlet Obstruction. This group of patients is known to demonstrate improvement following TURP, the company said.
The UroCuff CT3000 uses a method similar to that for blood pressure measurement. A penile cuff is fitted to the patient who is then asked to void into an integral uroflow instrument. An estimate of isovolumetric bladder pressure and a measurement of maximum flow rate are obtained to allow categorization into obstructed, not obstructed, or "diagnostically uncertain" groups.
Studies have shown that the 87% success rate for TURP in men classified as obstructed was similar to that achieved by invasive urodynamics in previous studies (79% to 93%), according to SRS. The company said more than 40 peer-reviewed publications now attest to the clinical use of the UroCuff CT3000.
The device was developed by scientists from the Freeman Hospital (Newcastle-Upon-Tyne, UK) and validated by the clinical team at Bristol Urology Institute (Southmead, Bristol, UK). Mediplus, a manufacturer of disposables for urodynamics and other medical specialties, markets the product and SRS has been granted a sub-license for exclusive U.S. distribution and worldwide manufacturing.
In other news from the meeting:
• The AUA introduced clinical guidelines with best practice statements for prostate cryotherapy. The guidelines state that cryoablation is a treatment option for men with clinically confined prostate cancer of any grade and that salvage cryoablation is a treatment option in men who have failed radiation therapy.
Prostate cryotherapy uses extreme cold to freeze and destroy prostate cancer cells. This minimally invasive procedure is routinely and successfully performed on prostate cancer patients with varying disease stages as well as those who have failed radiation treatment.
Richard Babaian, MD, professor and senior medical director at the MD Anderson Physician Network (Houston), presented the new guidelines for cryotherapy for the treatment of localized prostate cancer at the plenary session of the annual meeting.
• NDS Surgical Imaging (San Jose, California) reported availability of new visualization technologies for surgical and endoscopy suites, including a new Radiance 52" touch-screen display. These new products were on display at the AUA conference, the company said, as well as the Digestive Disease Week conference in San Diego.
The company said it demonstrated an interactive, purpose-built Radiance 52" touch-screen combined with imaging informatics platforms designed to deliver customized clinical content to operating room staff and enhance surgical workflow. It also showcased an LED-backlit surgical display technology that is supposed to provide "superb" brightness designed specifically for endoscopic use.