Expanded CE Mark for Mauna Key’s Cellvizio System

Expanded CE Mark for Mauna Key’s Cellvizio System

Product received FDA 510(k) clearance last year.

Mauna Kea Technologies’ Cellvizio, a confocal laser endomicroscopy platform, has received an expanded CE Mark indication for laparoscopic procedures, the French devicemaker announced.

The platform previously was indicated for use in the gastrointestinal tract and the urinary and respiratory systems, as well as the biliary and pancreatic ducts and for fine-needle aspiration procedures.

Cellvizio’s imaging system, which allows internal tissue to be visualized at the microscopic level, could enable improved frozen section sampling, more accurate tumor margin detection and better surgical planning, company executives said in a news release.

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.

“Cellvizio is able to provide important digital information in real time while overcoming the physical barrier of the OR," said Silvana Perretta, M.D., of IRCAD-EITS, a minimally invasive surgery training center at the University of Strasbourg in France. "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.”

Cellvizio received U.S. Food and Drug Administration 510(k) clearance last year. It also has been approved in China and Japan.

“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," said Sacha Loiseau, CEO and founder of Mauna Kea Technologies. "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 technology will continue to expand rapidly in the European Union and around the world.”

Mauna Kea designs, develops and markets tools to visualize and detect cell abnormalities in real time during standard gastrointestinal and pulmonary endoscopy procedures. The company's flagship product, Cellvizio, a probe needle-based Confocal Laser Endomicroscopy system, provides doctors and researchers with high-resolution cellular imaging of internal tissues.

Watch the video below to better understand the way Cellvizio works:


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