A Medical Device Daily

A "significantly more accurate" way of calculating the dosimetry of cancer treatments will be introduced by Varian Medical Systems (Palo Alto, California) at this week's GEC-ESTRO exhibition in Porto, Portgual.

BrachyVision Acuros enables clinicians to rapidly calculate patient doses for brachytherapy treatments (a form of radiotherapy) with an extremely high level of accuracy.

"This is a quantum leap forward in terms of accuracy with timeframes that were previously thought unimaginable," says Sophie Wetherall, Varian BrachyTherapy software product manager. "BrachyVision Acuros offers an improvement in dose calculation that will help clinicians make better decisions about dose to their patients and further their knowledge to make treatments more accurate."

Dose levels for brachytherapy have generally been calculated as if the sources are surrounded by water, whereas in reality a patient's anatomy contains many different materials such as bone, lung, tissue and air, as well as additional materials that are often present from inserted applicators. In the past the only way to account for this was using "Monte Carlo" calculation techniques, something that was only available as a research tool. Now, for the first time in routine clinical brachytherapy, BrachyVision Acuros is able to account for the dose effects from these variations.

"BrachyVision Acuros calculation times tend to average between three and eight minutes depending on the applicator used," Wetherall said. "By comparison, the same calculations could take hours or days using the standard Monte Carlo method."

Acuros, developed by Transpire (Charlottesville, Virginia), is an optimized, radiotherapy-specific rewrite of the software product Attila, and Varian is working exclusively with Transpire to bring its benefits to the radiation oncology field. In so doing, Varian said it becomes the only brachytherapy supplier with this capability in a commercially available product.

BrachyVision Acuros, which uses a technique described as a "Grid-Based Boltzmann Solver" (GBBS), is the most significant additional feature of Varian's latest brachytherapy treatment planning software offering, BrachyVision 8.8. The full system will be demonstrated for the first time at GEC-ESTRO.

"We are thrilled to be partnering with Varian Medical Systems in introducing the Acuros technology to the clinic," said Transpire CEO Gregory Failla. "Varian's leading position in the worldwide radiation oncology market ensures that the maximum number of patients will benefit from the improved treatment quality made possible by BrachyVision Acuros."

100 MitraClip procedures

Evalve (Menlo Park, California), a developer of devices for the percutaneous repair of cardiac valves, said that the first 100 patients have been treated with the MitraClip system in Europe. The company said clinical results to date "underscore the acute clinical benefit for patients, demonstrate the potential for reduced hospital stays and improved quality of life for patients."

Of the procedures performed to date, Evalve said 93% resulted in an implant and the vast majority resulted in a satisfactory reduction of mitral regurgitation, as described by the physician at the time of the procedure. The MitraClip system is the only device commercially available in the European Union that provides a non-surgical mitral valve repair option for patients suffering from the effects of functional or degenerative mitral regurgitation (MR).

There are more than 600,000 new diagnoses of significant MR each year in Europe and the U.S.; but only 20% of these patients undergo surgery each year.

The company said many higher-risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.

"We have seen that the MitraClip therapy provides a valuable alternative for patients who are considered high risk or otherwise not good candidates for surgery," said Olaf Franzen, MD, interventionalist for adult structural and congenital heart disease at University Heart Center (Hamburg, Germany), the institution having treated the most patients to date in Europe. "With the MitraClip therapy ... we are able to improve the quality of life for many patients suffering from MR who otherwise would not have been able to receive treatment for their condition."

Patients have thus far been treated with the MitraClip system at 14 institutions throughout Europe.

Patent fights won, says Palomar

Palomar Medical Technologies (Burlington, Massachusetts), a developer of light-based systems for cosmetic treatments, reported winning two patent opposition cases held at the European Patent Office on May 6 and 13.

The opposition hearings concerned European patent Nos. 1 230 900 and 0 806 913, respectively, which correspond to U.S. patent Nos. 5,595,568 and 5,735,844.

Palomar said this light-based hair removal patent family already has been licensed to ten competitors and is the subject of patent infringement lawsuits against Candela (Wayland, Massachusetts) and Syneron Medical (Yokneam, Israel) in the U.S.

The company said a panel of three patent examiners from the European Patent Office upheld the patents as both novel and inventive over prior art raised by competitors.