Mauna Kea Technologies has secured CE Mark for the use of its multidisciplinary confocal laser endomicroscopy platform, Cellvizio, in minimally invasive laparoscopic surgical indications.
The European Union regulatory approval allows the use of Cellvizio to provide imaging support in an array of oncologic surgical procedures, many of which have already been investigated successfully in several clinical studies across Europe.
France’s University of Strasbourg IRCAD-EITS Dr Silvana Perretta 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."
Mauna Kea Technologies founder Sacha Loiseau 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.
"Based on a rapidly growing body of clinical evidence, Cellvizio is the ideal technology for integration into many surgical and interventional image-guided platforms.
"Based on versatility and ease-of-use, we feel confident that adoption and use of this landmark technology will continue to expand rapidly in the EU and around the world."
Cellvizio is an endomicroscopy system designed to generate optical biopsies, providing physicians with microscopic images of tissue instantaneously and in a minimally-invasive manner.
Access to real-time visualisation of tissue is likely to provide a range of benefits to surgeons and patients such as improved frozen section sampling, more accurate tumour margin detection and improved surgical planning.
The system is compatible and synergistic with macroscopic optical fluorescent imaging systems used in a broad spectrum of surgical applications.
In the current setting, the Celioflex Cellvizio probe can be delivered laparoscopically through a trocar and manipulated in the surgical field with standard laparoscopic hand-held instruments.
According to the company, usage of the Cellvizio probe with robotic instruments will be accessible in the future.