Cellvizio Optical Biopsies Approved by Japanese Regulators

The technique of optical biopsy achieved another milestone when Paris-based Mauna Kea Technologies announced that their flagship Cellvizio product had been approved by Japan's Ministry of Health, Labor and Welfare (MHLW).

The approval includes Class 1 as well as Class 2 designations, which cover the use of Cellvizio probes in endoscopic use. The company says the approval applies to all current Cellvizio indications, including gastrointestinal, urologic, and respiratory applications.

Mauna Kea's website describes its Cellvizio system as an endomicroscopy system which generates optical biopsies. These provide physicians with microscopic images of tissue instantaneously and in a minimally-invasive manner. Based on simple pattern recognition, the company says, Cellvizio facilitates better decision-making and appropriate patient management.

According to Wikipedia, "(t)he Cellvizio system can be used during any endoscopy procedure, offering a cellular-level view of internal tissue. Large, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians to more accurately detect disease in real time, confirm the absence of disease and make immediate treatment decisions.

"The Cellvizio system includes miniaturized optics, optical fiber bundles, high-speed scanning and advanced image processing components. The embedded real-time image processing software, combined with a high-speed Laser Scanning Unit (LSU), allows the Cellvizo system to produce sharp images at 12 frames per second."

"We already have Cellvizio at Fujita Health University and have seen firsthand the significant advantages that this advanced endomicroscopy technology provides to both clinicians and patients," said Ichiro Hirata, MD, chairman and professor in the Division of Gastroenterology, Fujita Health University. Hirata is also the incoming president of the Japan Gastroenterological Endoscopy Society (JGES).

"Cellvizio represents a great potential for the management of patients with peripheral, potentially cancerous nodules and diffuse lung diseases", said Kazuyoshi Imaizumi, MD, professor in the Division of Respiratory Medicine and Clinical Allergy at Fujita Health University. "We look forward to performing ground-breaking work in Japan where the need for better pulmonary care is important."

Mauna Kea first received US FDA approval in 2011 for its current Cellvizio 100 Confocal Laser Endomicroscopy (pCLE) system for biopsies of the gastrointestinal (GI) and pulmonary tracts. Just this past March, the company received 510(k) clearance from FDA for the expanded indications of the urology field. Cellvizio's Uroflex B and CystoFlex F Confocal Miniprobes are now approved for use "within anatomical tracts including but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories."

In the press release announcing the urologic indications approval, Joseph Liao, MD, associate professor of urology, Stanford University, and Chief of Urology at the Veterans Affairs Hospital in Palo Alto, CA, said, "This important approval is based on years of clinical research that has demonstrated the benefits of Cellvizio in a range of urological indications," Liao continued, "This technology offers urologists an exciting new window to visualize urological cancers, particularly bladder, and improve their detection and resection."

Stephen Levy is a contributor to Qmed and MPMN.