Jun 11 2015
Mauna Kea Technologies, inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, announced today CE mark for the use of Cellvizio in interventional radiology indications. This new regulatory milestone positions Cellvizio as a unique adjunct to important therapeutic procedures that are in great need for direct and real-time image-guidance.
"Interventional radiology is all about using our powerful non-invasive imaging modalities to guide and deliver treatments locally, as an alternative to surgical or systemic chemotherapy approaches. With the combination of Cellvizio with our existing image-guided platforms, we could be reaching a new level of precision and efficacy in our interventions," said Pr. Afshin Gangi, Chief of Interventional Radiology at the Nouvel Hôpital Civil in Strasbourg, France. "We have been very pleased with our initial experience over the past few months and are excited about this regulatory approval which will enable a faster development going forward."
Cellvizio brings real-time visualization of tissue at the microscopic level, representing a major advance in image-guided interventions. In this setting, the AQ-Flex 19 IR Cellvizio probe can be delivered through a standard percutaneous needle and provide microscopic images of lesions within solid organs such as the liver, kidney, or lung. Access to Cellvizio imaging during the procedure may provide a wide range of benefits to patients such as real-time assessment of needle-placement before focal therapeutic interventions and evaluation of completeness of tumor ablation.
Sacha Loiseau, CEO and founder of Mauna Kea Technologies declared, "While this approval is an important accomplishment for Cellvizio and a meaningful potential commercial opportunity, we do not expect Mauna Kea to be the primary marketer of AQ-Flex 19 IR as we believe that full integration of our proprietary technology into an existing interventional radiology platform would lead to a more rapid adoption of Cellvizio in this community."