Mauna Kea (ENT:MKEA) said yesterday that it won expanded CE Mark approval in the European Union for its Cellvizio imaging device in minimally invasive laparoscopic surgical indications.
The Cellvizio device is designed for use in a variety of oncologic surgical procedures, providing real time visualization at the microscopic level, the company said.
Cellvizio already won 510(k) clearance from the FDA and a CE Mark for Cellvizion’s use in the GI tract, biliary and pancreatic ducts and lungs, the French device manufacturer said. Cellvizio also has SFDA approval in China and MHLW approval in Japan, Paris-based Mauna Kea 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," Dr. Silvana Perretta,of the University of Strasbourg said.
Mauna Kea said it’s planning to offer Cellvizio for use with robotic surgical “in the near future.”
"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," CEO Sacha Loiseau said.