Mauna Kea Technologies, inventor of Cellvizio, the multidisciplinary confocal laser endomicroscopy platform, announced CE mark for the use of Cellvizio in minimally invasive laparoscopic surgical indications.
This regulatory milestone positions Cellvizio for useful imaging support in a wide range of oncologic surgical procedures, many of which have already been investigated successfully in several clinical studies throughout Europe.
Cellvizio brings real-time visualization of tissue at the microscopic level, representing a major advance in image-guided surgery.
In this setting, the Celioflex Cellvizio probe can be delivered laparoscopically through a trocar and manipulated in the surgical field with standard laparoscopic hand-held instruments. Usage of the Cellvizio probe with robotic instruments will be accessible in the near future.
Access to real-time visualization of tissue may provide a range of benefits to surgeons and patients such as improved frozen section sampling, more accurate tumor margin detection and improved surgical planning. In addition, Cellvizio is compatible and synergistic with macroscopic optical fluorescent imaging systems currently used in a range of surgical applications.
Dr Silvana Perretta, from IRCAD-EITS, University of Strasbourg, France, said, "Cellvizio is able to provide important digital information in real time while overcoming the physical barrier of the OR. The ability to bring this new level of knowledge and precision into the surgical field is a significant advantage as the global focus on evidenced-based medicine continues to expand."
Sacha Loiseau, CEO and founder of Mauna Kea Technologies, said, "While we view this achievement as an important regulatory milestone for the company, it is also the next step in our ongoing effort to position this technology to transform how surgery is performed in the years ahead."