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BrainLAB Announces 510(k) FDA Clearance of Monte Carlo Dose Engine for Stereotactic Radiosurgery and Radiation Therapy

High Performance Monte Carlo Algorithm Generates Precise Dose Calculations

Within Seconds

WESTCHESTER, Ill., July 29 /PRNewswire/ -- BrainLAB, a leader in software-driven systems for targeted, less-invasive medical treatments, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Monte Carlo Dose Calculation Algorithm, which is already being used at several clinical cooperation sites worldwide.

In the past, clinicians had limited treatment choices or have been unable to include Monte Carlo method calculations into their routine for dose calculation due to numerous factors such as the extreme amount of time needed, restrictions of treatment planning software to a single machine or treatment modality and its integration into available software. Although the Monte Carlo algorithm is widely accepted as the gold standard for calculation in treatment planning accuracy, the aforementioned limitations have inhibited its clinical implementation. To offer superior treatment possibilities for patients and tools that seamlessly integrate into the clinical workflow, BrainLAB has developed new Monte Carlo Dose Calculation software that makes high-precision treatment available in everyday clinical practice.

The BrainLAB Monte Carlo Dose Calculation software is a high performance Monte Carlo algorithm for therapeutic photon beams supporting nearly all linear accelerator and multi-leaf collimator (MLC) types. Monte Carlo is now available as an option on the iPlan(R) RT Dose treatment planning software. Dose calculations can be completed within seconds for conformal beam and dynamic arc treatments and within a few minutes for complex IMRT cases.

"The new BrainLAB Monte Carlo algorithm integrates some of the most advanced image registration and segmentation tools available in the clinical environment, providing a powerful tool to tackle the most challenging radiosurgery cases in lung and head & neck sites. It is clearly a much needed advancement in the field of radiosurgery treatment planning," said Kamil Yenice, Ph.D., Chief of Clinical Physics, University of Chicago, Department of Radiation and Cellular Oncology.

This powerful dose calculation engine provides an advanced level of integration, which means its use is not limited to a single machine, multi-leaf collimator, energy or treatment modality and can be seamlessly integrated to drive treatment with Varian, Siemens, and Elekta MLCs and linear accelerators. The multitude of treatment plans supported by the Monte Carlo Dose Calculation Algorithm, which include conformal beam, static and dynamic arc, and IMRT treatment modalities, makes it a powerful solution for radiotherapy today and the future.

"We believe that the release of the BrainLAB Monte Carlo Dose Calculation Algorithm will have a great impact on the field of radiosurgery. We continue to develop software solutions that extend clinicians' treatment precision to cover more extra-cranial cancers as well as advanced dose calculation possibilities for lung and head & neck tumors," said David J. Brett, Product Manager iPlan Oncology, BrainLAB.

The Monte Carlo Dose Algorithm was developed by physicist Matthias Fippel, Ph.D., Senior Software Engineer at BrainLAB, who has published numerous clinical papers on the subject over the past 10 years. Fippel is seen to be one of the foremost experts in the field and previously worked on Monte Carlo research projects at the University of Leipzig and the University of Tubingen in Germany. The Monte Carlo Dose Calculation Algorithm is based on the XVMC (X-Ray Voxel Monte Carlo) algorithm and has been verified using the widely respected EGSnrc and BEAMnrc software algorithms. The advanced dose calculation solution from BrainLAB is based on the Monte Carlo method of modeling the transport of radiation through a beam collimation system (micro multi-leaf collimator, or MLC) and through human tissue. Monte Carlo requires a 3D CT-scan of the patient's tissue to create an internal model of the patient and to calculate the dose distribution of the radiation emitted by a linear accelerator. The present implementation is designed to model photon radiation.

Conventional dose calculation algorithms, such as Pencil Beam, were used for cranial as well as extra-cranial indications before the application of the Monte Carlo method in the field of radiation therapy. Pencil Beam has proven effective for tumors located in homogeneous regions with similar tissue consistency such as the brain. However, these algorithms tend to overestimate the dose distribution in extra-cranial tumors such as in the lung and head & neck regions where large inhomogenities exist because of the proximity of bone, soft tissue and air cavities. Due to the inconsistencies seen in current calculation methods for extra-cranial treatments and the need for more precise radiation delivery, research has led to the creation and integration of improved calculation methods into treatment planning.

Many clinicians see the Monte Carlo Dose Calculation Algorithm as a superior algorithm for lung and head & neck treatments as compared to other computing algorithms, such as the collapsed cone or convolution methods.

The BrainLAB Monte Carlo Dose Calculation Algorithm is an integral part of the iPlan RT Dose software version 4 and provides clinicians with additional dose planning options, offering more informed treatment planning and improved clinical outcomes.

About BrainLAB

BrainLAB develops manufactures and markets software-driven medical technology that enables procedures that are more precise, less invasive, and less expensive than traditional treatments. Among the core products are image-guided systems that provide highly accurate real-time information used for navigation during surgical procedures. This utility has been further expanded to serve as a computer terminal for physicians to more effectively access and interpret diagnostic scans and other digital information for better informed decisions. With more than 3,000 systems installed in over 70 countries, BrainLAB is a market leader in image-guided technology. The privately held BrainLAB group, founded in 1989, is headquartered in Munich, Germany and today employs 1,000 people in 16 offices across Europe, Asia, Australia, and North and South America.

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