IBA receives FDA approval for its Proton Therapy Specific Cone Beam CT (CBCT) Solution
IBA’s CBCT solution opens the way to increased proton therapy accuracy.
Louvain-la-Neuve, Belgium, July 30th, 2014, IBA (Ion Beam Applications SA), the world’s leading provider of proton therapy solutions for the treatment of cancer, announces today that it has received combined clearances from the U.S. Food and Drug Administration (FDA) that will enable IBA to market-launch the Proton Therapy specific Cone Beam Computed Tomography (CBCT) solution. IBA has received clearance from the FDA for its imaging platform adaPT Insight* (FDA 510(k) K132847) and for the Compact Gantry Beam Line (FDA 510(k) K132919). Those combined clearances will enable the CBCT solution to be marketed in IBA’s two Proton Therapy solutions Proteus®PLUS** and Proteus®ONE*** in 2014 and 2015 respectively.
As a component of IBA’s Image Guided Proton Therapy (IGPT) solution, CBCT provides 3D imaging for increased accuracy in patient treatment. It is fully integrated with IBA’s imaging platform adaPT Insight*, to offer fast 6D corrections of patient positioning for IBA’s Proteus®PLUS** and Proteus®ONE*** proton therapy solutions. IBA’s first CBCT is at the validation phase and the first clinical use is expected for the second half of 2014.
Olivier Legrain, Chief Executive Officer of IBA commented: “We are delighted to be the first company to receive Marketing Authorization from the FDA for the Proton Therapy specific CBCT technology. The development of imaging capabilities is critical to the expansion of the use of proton therapy in new cancer indications and IBA has developed advanced radiation therapy solutions that improve the overall treatment experience for both clinicians and patients. CBCT is just one example of the latest technological advancements achieved by IBA as we maintain our unrivalled position as the world’s leader in the innovation and delivery of proton therapy.”
Frederic Genin, Executive VP Product Management at IBA added: “IBA’s significant experience and successful collaborations with key users make it possible to achieve this milestone in the development of specific imaging solutions for proton therapy. Specific applications of image guidance and image monitoring are of paramount importance to benefit from the superior dose distribution of proton therapy. By adding Cone Beam CT as one of IBA’s Image Guided Proton Therapy solutions, we are leading the development of Adaptive Proton Therapy.”
* adaPT Insight is the first FDA cleared CBCT software solution in Proton Therapy. adaPT Insight is the brand name of the I2C software suite applicable to the IBA Proton Therapy solutions. (I2C: FDA 510(k) K132847).
** Proteus®PLUS is the brand name of a configuration of the Proteus® 235.
*** Proteus®ONE is the brand name of a configuration of the Proteus® 235.