A Medical Device Daily

Using equipment from Varian Medical Systems (Palo Alto, California), a team at Lindenhofspital (Bern, Switzerland) has delivered three highly-focused, powerful radiotherapy doses aimed at destroying a small tumor on the lung of a 36-year-old female patient, marking the first treatment in that country using a technique known as extra-cranial stereotactic radiotherapy.

Leon Andre, MD, medical physicist at the private hospital, said the tumor has shrunk as a result of the treatment and the patient is now "recovering well."

The treatment involved use of a Varian Clinac 23EX linear accelerator with a 120-leaf MLC (multileaf collimator) to enable clinicians to narrow down the beam to millimeter accuracy, reducing the risk of side effects.

"Surgery was not an option for this patient because her other lung had been removed a year ago," Andre said. "A new tumor appeared on her remaining lung and we decided that the best option would be to deliver three high-dose stereotactic treatments over a 10-day period. We are very pleased with the way the patient has responded to this new treatment."

Varian said that stereotactic radiation often is used for cranial tumors, but recent advances in real-time imaging equipment and beam-shaping devices have broadened its use to the rest of the body.

"These advances include the On-Board Imager, a state-of-the-art imaging device which extends from the linear accelerator and enables highly accurate Image Guided Radiotherapy (IGRT) treatments, and the 120-leaf Millennium multi-leaf collimator, which allows the beam to be shaped to extreme levels of precision," Andre said. "The recent availability of IGRT solutions in general and conebeam CT imaging in particular have meant a tremendous improvement in treatments." He added that stereotactic radiosurgery "now offers many patients treatment options for tumors that could not have been treated before."

Varian said more than 450 On-Board Imager devices have been installed or are in the process of being installed in hospitals around the world.

In Europe, the company operates manufacturing and engineering centers in Baden, Switzerland; Crawley, UK; Haan, Germany; Helsinki, Finland; and Toulouse, France. Its headquarters for Europe, Middle East, India and Africa are in Zug, Switzerland.

CE mark for Stereotaxis catheter

Stereotaxis (St. Louis) reported that its partnered magnetic irrigated ablation catheter has received CE-marking and will be available in Europe in the near future.

The company called the catheter "an important addition" to its line of magnetic ablation catheters and that it "further expands electrophysiology applications for the Stereotaxis Magnetic Navigation system."

In a statement, the company said the catheter, which gives physicians the ability to deliver high-power ablations for the treatment of complex arrhythmias such as atrial fibrillation and ventricular tachycardia, is expected to "further increase utilization in existing European sites and stimulate new system sales in the second half of 2007 and beyond."

CEO Bevil Hogg said, "The timely completion of this important regulatory milestone . . . is a significant step toward our goal of establishing a new standard of care in the safe and effective treatment of complex arrhythmias."

Medala eyes German wound-healing market

Medela Healthcare (McHenry, Illinois) said it has filed a claim in the German District Court of Wiesbaden asking the court to modify an agreement with Kinetic Concepts (KCI; San Antonio) concerning the sale of Medela Vario pumps in Germany.

The agreement, reached between Medela and KCI in 2001, settled a competitive issue between the two companies. Medela committed not to sell the Vario aspirator pump for wound-healing use because Medela did not include "wound healing" in the CE certification and the pump's manual.

Since then, Medela has included wound healing in the CE certification for the product and has updated the Vario aspirator pump manual. The Vario is an electrical- and battery-powered suction pump used for wound healing by applying negative pressure to the wound site. It is used in tandem with wound dressing.

Medela serves customers through 12 subsidiaries and a network of distribution partners in more than 90 countries.

U.S. trial resumes for Ablatherm-HIFU

EDAP TMS (Lyon, France), a leader in high-intensity focused ultrasound (HIFU) treatment of prostate cancer, reported continuation of its U.S. Phase II/III clinical trial with treatment of an additional two patients at Duke University Medical Center (Durham, North Carolina).

EDAP's Ablatherm-HIFU is a noninvasive therapy using highly focused ultrasound energy to ablate the prostate tissue.

Commenting on the resumption of the U.S. clinical trial, CEO Marc Oczachowski cited the company's "more than 10 years of experience in IFU therapy," and added: "[Our] success outside the U.S. is due to our clear commitment to clinical excellence, and we have absolute confidence our U.S. sites will adhere to the same high standards of excellence in the U.S. study programs."

"HIFU appears to very well tolerated, with minimal invasiveness and minor discomfort," said Cary Robertson, MD, associate professor in the division of urology at Duke University Medical Center. "This technology offers an alternative to other approved therapies for prostate cancer and may be effective in selected individuals as a primary therapy."