A Medical Device Daily

The results of a 16-month clinical study showing that the Cook Medical (Bloomington, Indiana) Resonance Metallic Ureteral Stent could remain in a patient for up to 12 months; generating a 43% cost savings in treating benign ureteral obstruction, was presented by Dr. Thomas Turk, a member of the study's investigative team, during a press conference at the 2009 American Urological Association (AUA; Baltimore, Maryland) conference in Chicago on Monday. These results are compared to alternative polymer stent treatment methods, which may require more frequent stent changes throughout the year.

The study, conducted by Hector Lopez Huertas, MD; Anthony Polcari, MD; Alex Acosta-Miranda, MD, and Turk at Loyola University Health System (Illinois) evaluated the safety, efficacy and cost of two stent options for the management of benign ureteral obstruction: polymer or metallic stents. The study found the annual costs associated with the repeated stent changes required in patients with polymer stents were nearly $23,999 as compared to patients with a metallic stent that can remain in the patient for up to 12 months, costing nearly $13,605. Therefore, the Cook Resonance Metallic Ureteral Stent was associated with an average cost savings of $10,394, representing the 43% reduction per patient per year.

The researchers reviewed data for 13 patients who underwent metallic ureteral stent placements from July 2007 through November 2008. These patients were all previously treated with polymer stents. The cost of stent maintenance for a 12-month interval using both polymer and metallic stents was then calculated for each patient. This was done by multiplying the number of stent changes required during the year prior to the metallic stent placement by the mean cost of a stent change. The study confirmed that the costs associated with plastic stent changes over a 12-month period could be more than double the cost of a Resonance implantation, as shown above.

In other conference news:

• As body mass increases, so does a patient's risk of urinary tract infection (UTI), according to Baltimore researchers. A new study, presented at the conference, assesses and stratifies this risk.

Researchers evaluated insurance claims of 95,962 subjects over a five-year period (from 2002 through 2006) to identify whether obesity is associated with a UTI diagnosis. The results show that, as BMI increased, the odds of being diagnosed with a UTI increased as well. This association was strongest for morbidly obese patients.

• Neuisys (Greensboro, North Carolina) a provider of CT and MRI systems to physician practices, reported at the AUA conference that the FDA has granted 510(k) clearance of UroCARE, a software application package for the assessment of urinary anatomy using multi-slice CT data.

UroCARE is an exclusive software package developed by Neusoft Medical Systems for the NeuViz Dual and NeuViz 16 CT systems. UroCARE is also compatible with DICOM compliant CT image sets, including those from other CT manufacturers, the company noted.

• Phase II data presented at the annual meeting of the AUA indicate that men suffering from an enlarged prostate may benefit from Botox injections.

The two-stage, multi-center, double-blind, randomized study showed that two different dose levels of Botulinium Neurotoxin Type A (Botox) injected into the prostate was both safe and effective for the management of benign prostatic hyperplasia (BPH), a common noncancerous enlargement of the prostate that can cause difficulty in urination.

Study results included data from 125 men with BPH, aged 50 and older, and treatment success was defined in terms of efficacy and safety over a 12-week timeframe. Patients were assigned to receive either 100 units or 300 units of Botox. Seventy-three percent of patients taking 100 units and 81% taking 300 units passed the cut offs for efficacy, defined as 30% or more improvement from baseline. Both doses also passed the safety criteria. Specifically, there were no grade four or five toxicity events observed in either dose, and only 17% in the 100 dose and 18% in the 300 dose reported grade two or three events.

• Results from a nationwide survey of women ages 40 to 65 show that the symptoms of overactive bladder (OAB) are compromising their sense of normalcy and making their complicated lives even more difficult to manage. The survey, conducted for The National Association For Continence (NAFC; Charleston, South Carolina) by Kelton Research and sponsored by Medtronic (Minneapolis) compared women ages 40 to 65 who have experienced symptoms of OAB, which affect as many as 33 million Americans, to women in the same age group overall.

• In an unveiling held at the AUA conference, Dornier Medtech (Wessling, Germany) revealed a flat panel detector for the Opus II UIMS.

The urology system offers a 43 x 43 cm dynamic flat panel detector with over scan capability that complements brachytherapy applications. According to the company, the large, fully digital system produces an undistorted true rectangular image. In comparison to a traditional 16-inch image intensifier, the flat panel detector provides 92% more imaging area, increasing the amount of information seen by the user, the company said. The Opus II UIMS fpd is now the most advanced urology table in the market with the user-friendly carbon fiber table design that is thin, light weight and has the shortest tabletop and smallest table footprint in the industry, according to Dornier Medtech.

• Urologix (Minneapolis) reported the launch of the CTC Advance Short treatment catheter. In addition to this new BPH treatment catheter, the company also reported AUA acceptance of two moderated poster presentations highlighting the data from clinical studies of the Urologix Cooled ThermoTherapy treatment. Urologix says its Cooled ThermoTherapy is a customizable and durable nonsurgical treatment for enlarged prostate disease, also known as BPH.

The new Urologix CTC Advance Short tailors the size and power setting of the CTC Advance catheter to treat smaller prostate glands while maintaining the improvements in cooling and flexibility compared to the predecessor CTC catheter, Urologix noted. According to the company, market feedback from the first cases with the CTC Advance Short supports the goal of improved ease of use and treatment toleration.