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

By Brainlab, PRNE
Monday, May 9, 2011

New Planning Software to Make Advanced, Complex Treatments Possible for More Patients

PARIS, May 10, 2011 - Brainlab has received 510(k) clearance from the U.S. Food and
Drug Administration (FDA) for its HybridArc(TM) 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

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 through 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
centre 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 eye sight, 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
the 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, 8-12 May 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 US. 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

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

Press enquiries: Rob Jones / Emma Lewis-Griffiths, Contact: brainlab at, +44(0)7768-637786; Issued by: Pegasus Public Relations

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