A Medical Device Daily

Two U.S. firms, American Medical Systems Holdings (AMS; Minnetonka, Minnesota) and Misonix (Farmingdale, New York), were in the spotlight at last month's conference of the European Association of Urology (EAU; ) in Berlin, Germany, with product introductions and reported initial treatments with products.

AMS reported the addition of GreenLight laser therapy to its portfolio of pelvic health solutions in Europe, and it also marked the European launch of the GreenLight High-Performance System (HPS) to treat benign prostatic hyperplasia (BPH), designed to increase the range of treatable gland sizes and reduce surgical time.

For its part, Misonix reported the results from its first human kidney cancer treatments using the Sonatherm 600, a device using high-intensity focused ultrasound (HIFU). Dr. Michael Marberger, chairman and professor of the department of urology at the University of Vienna Medical School, where the treatments were performed, said procedures were successfully completed with positive ablation effect noted on cancer cells in tumors within human kidneys.

The trial patients treated by Marberger's team were diagnosed to have cancerous kidney tumors and were candidates for full or partial nephrectomies, the surgical removal of a kidney.

Each patient agreed to first have the kidney cancer treated laparoscopically with HIFU from the Sonatherm 600 with the kidney still in place and then before a nephrectomy was performed. After the cancerous areas of the kidney were removed through the traditional, surgical methods, the HIFU-treated areas were tested outside of the patient's body. The results showed positive ablation of cancerous tissue treated by the Sonatherm.

"Using the Sonatherm technology to treat the cancer while keeping the kidney in place is a breakthrough process," Marberger said. "The process is unique and our preliminary results to date in using the device are very exciting."

"The Sonatherm 600 is an important new development for minimally invasive treatment of kidney cancer," said Mark Sullivan, MD, senior laparoscopic surgeon at Oxford University Hospital (Oxford, UK). "The ability of this device to laparoscopically treat cancerous cells in the kidney effectively and safely has the potential to eliminate the need for nephrectomies, which may jeopardize patients' health and are costly."

The results were the primary topic of discussion at the first-ever international Laparoscopic Kidney HIFU study group meeting, held as a Misonix-sponsored event during the EAU conference.

Surgeons from Oxford University Hospital and Giovanni Bosco Hospital (Turin, Italy) also are performing human kidney procedures using the Sonatherm as part of Misonix's three-site clinical program.

The Sonatherm 600 was developed and is manufactured by Misonix, based on the HIFU technology of Focus Surgery (Indianapolis), a company in which. Misonix is an investor. Misonix also holds the worldwide and/or regional licenses to manufacture, market and sell HIFU devices relating to the treatment of tissue in the prostate, liver and breast that it acquired from Focus.

Michael McManus Jr, president/CEO of Misonix, said, "With an entire day of EAU 2007 devoted to minimally invasive technologies and the participation of hundreds of surgeons from countries throughout Europe and around the world, it is clear that Misonix's research and product development pursuits using HIFU technology are of significance to the global healthcare community."

Misonix also reported that more than 200 urologists and related medical professionals from throughout Europe attended, on-site or via teleconference, a live procedure using the Sonablate 500 device for non-invasive HIFU treatment of prostate cancer also developed by Focus Surgery and manufactured by Misonix. Misonix also has the exclusive European distribution rights for that product.

Martin Emerson, president/CEO of AMS, said, "The global reach of AMS enables us to bring the benefits of GreenLight, which is becoming the new gold standard for BPH treatment, to more patients than ever before."

AMS acquired GreenLight as part of its recent purchase of Laserscope (San Jose, California) last summer (Medical Device Daily; July 21, 2006), and the laser therapy business has been fully integrated into AMS.

More than 1 million men worldwide seek surgical treatment each year for obstructive BPH, a non-cancerous condition in which the prostate grows and obstructs ordinary urethral function requiring tissue removal for patient relief. AMS said GreenLight laser therapy has won wide adoption as an alternative to more invasive surgical procedures, such as TURP, by physicians.

"I have treated over 600 patients using GreenLight laser therapy," said Fernando Gomez Sancha, MD, of Instituto de Cirugia Urologica Avanzada (Madrid, Spain). "After our outstanding results, we decided to stop using the traditional surgical treatments of TURP and open prostatectomy. This laser is reshaping prostatic surgery in the same way lithotripsy reshaped stone surgery."

Cepheid releases Smart HBV assay

Cepheid (Sunnyvale, California), a broad-based molecular diagnostics company, reported the European release of the Smart HBV (Hepatitis B Virus) Assay for clinical diagnostic use on the SmartCycler System.

The SmartCycler System is a major real-time polymerase chain reaction testing platform for hospitals, university labs and government agencies. The HBV assay was released as a CE IVD mark product under the European Directive on In Vitro Diagnostic Medical Devices, the most rigorous EU requirement, and is intended for the rapid identification of HBV viral load.

According to the World Health Organization (Geneva), of the 2 billion people infected with the HBV virus, more than 350 million will have chronic, lifelong infections, all at high risk of death from cirrhosis or scarring of the liver and liver cancer, which kill roughly 1 million each year.

"The Smart HBV test developed and produced at our Cepheid AB facility in Stockholm extends and complements our existing line of products for monitoring of viral load in the management of transplant patients," said John Bishop, CEO of Cepheid. "In addition, we believe the test will be an accurate indicator of responses to antiviral therapy in patients being treated for chronic hepatitis B, and its genotype independence ensures that it can be used in all parts of the world in which HBV is endemic"

Bishop said Cepheid plans to continue to expand its test menu on the SmartCycler system and to adapt those tests, as appropriate, to the company's fully integrated GeneXpert system."