Brainlab Announces FDA 510(k) Clearance for New HybridArc™ Software for Radiosurgery

MUNICH, May 10, 2011 /PRNewswire/ -- Brainlab has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its HybridArc™ radiosurgery planning solution. This innovative software package will enable healthcare professionals to increase the efficiency of existing Linac (linear accelerator) radiosurgery hardware and offer fast, high precision volumetric arc radiosurgery treatment without the need for costly hardware upgrades.

HybridArc expands upon the clinically proven and well-established Dynamic Arc stereotactic treatment technique to offer high dose conformity to the target, while sparing nearby organs and offering less residual dose when compared to other techniques such as rotational Intensity Modulated Radiotherapy.

With over 20 years of experience in stereotactic radiosurgery for small field treatments of the brain and spine, Brainlab has facilitated high accuracy treatments for hundreds of thousands of patients worldwide. Developed with highest accuracy in mind, HybridArc uses an adaptive dose calculation matrix that takes into account the different parameters affecting dose distribution to provide the necessary precision when opting for stereotactic radiosurgery. By using software automation, HybridArc calculates plans typically within a few minutes. Coupled with reduced treatment times, more patients can potentially benefit from advanced radiosurgery. From planning to patient treatment, HybridArc ensures clinicians can meet the demands of high dose single fraction radiosurgery.

Thierry Gevaert, medical physicist at Universitair Ziekenhuis, Brussels, Belgium, who will be using the new system at his radiosurgery center, comments: "We have looked at HybridArc as a cost-effective way to expand and improve on the capabilities offered by our current radiosurgery system. By using HybridArc we can get the most from our treatment machine, and treat more patients with precision and speed without having to invest in an expensive new system."

David Brett, director of marketing for radiosurgery at Brainlab, comments: "HybridArc is the next evolutionary step in radiosurgery treatment planning from Brainlab that automates and streamlines the planning process without compromise. By enabling doctors to accurately cover the target while preserving vital function such as hearing or eyesight, Brainlab provides new possibilities in cancer care. We continually strive to provide clinicians tools that minimize side effects, reduce treatment times and increase access to medical technology."

HybridArc is a flexible option for hospitals that either have state-of-the-art Linac treatment technology or those that want to gain the capability of advanced radiosurgery without an expensive hardware upgrade. HybridArc treatments can be delivered on most Linac-based radiosurgery systems, unlike many other treatment tools which require expensive or brand-new Linac systems to be purchased or costly upgrades.

Notes to editors:

Data on initial clinical experience with HybridArc radiosurgery planning will be presented at the 10th Biennial Conference of the International Stereotactic Radiosurgery Society, May 8-12, 2011.

About HybridArc

HybridArc dose planning software provides the required accuracy and resolution dedicated to cranial and spinal radiosurgery. HybridArc intelligently combines enhanced dynamic conformal arcs (or modulated arcs) and static-intensity modulated radiotherapy beams in the same plane, for an efficient volumetric radiosurgery dose plan that only takes seconds to optimize. HybridArc can also achieve shorter treatment times while potentially improving the dosimetric results as compared to established techniques used alone.

HybridArc is approved for use in Europe and the United States. For availability in other countries, please contact Brainlab.

About Brainlab

Brainlab develops, manufactures and markets software-driven medical technology that supports targeted, less-invasive treatment. Core products are image-guided systems and software that provide real-time information used for surgical navigation and radiosurgical planning and delivery. Brainlab technology drives collaboration between hospitals and clinicians from a wide variety of subspecialties—from neurosurgery and oncology to orthopedics, ENT, CMF and spine & trauma. This integration delivers better access to improved and more efficient treatment.

Founded in 1989, the privately held Brainlab group has more than 5,000 systems installed in over 80 countries. Based in Munich, Germany, Brainlab employs 950 people in 16 offices worldwide. To learn more, visit www.brainlab.com.

SOURCE Brainlab

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