A Medical Device Daily

EDAP (Lyon, France) said it is "fast-tracking" its ongoing U.S. Ablatherm-HIFU clinical trial. According to the company, long-term European results presented at the European Association of Urologists (EAU; Arnhem, the Netherlands) meeting in March paved the way for "unprecedented interest from the U.S. medical community about Ablatherm-HIFU" at AUA.

Christian Chaussy, MD, of the Department of Urology, Krankenhaus Muenchen-Harlaching (Munich, Germany), said, "We have treated more than 1,800 patients in our center over 10 years, and we now have mature data that demonstrates the long-term benefits of Ablatherm-HIFU. Given the success we've had in Europe, and the clear consensus from urologists that this therapy is a good selection for patients, it is a priority to make this leading-edge, non-invasive treatment available in the U.S."

"We are also seeing more and more patients coming to Munich from the U.S. to receive Ablatherm-HIFU treatment."

The U.S. Ablatherm-HIFU clinical study is enrolling men age 50 and up, diagnosed with localized prostate cancer.

The Ablatherm Integrated Imaging device delivers high-intensity focused ultrasound (HIFU) energy to the prostate, resulting in thermal destruction of prostate tissue. It is intended for the primary treatment of localized prostate cancer in subjects with low-risk, localized cancer.

The focused energy is delivered from an endorectal probe containing ultrasound treatment and imaging transducers. HIFU for low risk, localized prostate cancer subjects is expected to result in immediate thermal destruction of prostate tissue, according to EDAP. The treatment is conducted under spinal or general anesthesia during one two-hour session, with patients able to resume normal activity within 24 hours, the company said.

In other news from the AUA:

• Matritech (Newton, Massachusetts) said its NMP22 BladderCheck Test was recognized by clinical investigators at AUA for use in diagnosing and managing bladder cancer. New information showing the reliability of the test as a diagnostic tool in evaluating patients with risk factors for bladder cancer was also presented.

People at risk for bladder cancer include long-time smokers, workers in manufacturing areas where particulate matter is concentrated, workers who encounter chemical vapors including hair dyes, and fire fighters who are exposed to toxic fumes, the company noted.

The NMP22 BladderChek Test is designed to detect elevated levels of the NMP22 protein marker in a single urine sample. Most healthy individuals have very small amounts of the NMP22 protein marker in their urine, but bladder cancer patients commonly have elevated NMP22 marker levels, even at early stages of the disease, according to Matritech.

The company describes the test as a "painless and noninvasive assay," terming it "the only in-office test approved by the FDA for both the diagnosis and monitoring of bladder cancer." It is used in a physician's office, requires only four drops of urine and results are available in 30 minutes — during the patient visit, allowing a rapid and accurate way to aid in the detection of bladder cancer.

The test is reimbursed by Medicare and many medical insurers and has an average cost of less than $30. It has been shown to detect more than three times as many cancers as the commonly used laboratory-based urine cytology test, the company said.

The NMP22 BladderChek Test will be used in an independent large-scale multi-center bladder cancer screening study led by M.D. Anderson Cancer Center (Houston), the company said.

The test was included in the AUA State-of-the-Art Lecture: "Is Screening for Bladder Cancer Ready for Prime Time?" delivered by H. Barton Grossman, MD, deputy chairman of the Department of Urology at M.D. Anderson. It also was the subject of two poster presentations: "Impact of Risk Factors on the Performance of a Point-of-Care Bladder Cancer Test," by Yair Lotan, MD, University of Texas, Southwestern Medical Center (Dallas); and "NMP22 as an Adjunct to Urine Cytology and Cystoscopy in Follow-up of Superficial TCC of the Urinary Bladder," by Narmada Gupta, MD, of the All India Institute of Medical Sciences (New Delhi, India).

• Viking Systems (San Diego), a maker of high-performance laparoscopic vision systems for use in minimally invasive surgical (MIS) procedures, reported on a poster by Jihad Kaouk, MD, of Cleveland Clinic (Cleveland, Ohio), titled "Suturing Using Articulated Needle Drivers and 3-D Vision," was presented at the conference. The poster demonstrates the advantages of using 3-D vision in laparoscopic suturing procedures in a pelvic trainer.

According to Viking, the researchers found that precision and accuracy were improved across all subject groups using novel articulated needle drivers (AND) and 3-D vision compared to straight conventional needle drivers (CND), which have a limited range of freedom. 3-D vision, according to the presentation, especially reduced the time to accomplish the tasks in the intermediate group, and the combination of AND and 3-D vision had benefits for both intermediate and novice groups.

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