Paris-based Mauna Kea Technologies (ENT:MKEA) said that it has received 510(k) clearance from FDA for the use of the Cellvizio AQ-Flex 19 Confocal Miniprobe through existing bronchoscopes, transbronchial needles, and other bronchoscopic accessories to detect lung cancer.
Cellvizio is a multidisciplinary probe-based and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform designed to aid clinicians in the diagnosis and treatment of cancer and other diseases using real-time, in vivo microscopic visualization, according to the company. This marks the 16th 510(k) clearance of the Cellvizio platform and its entry to the interventional pulmonary market.
Other navigation products provide advanced minimally invasive access to peripheral nodules but with limited ability to achieve direct visualization outside the airways, according to the company. The Cellvizio device can be used through the working channel of existing navigation products to provide direct “through the needle” visualization inside peripheral lesions.
“Our pioneering team has demonstrated that real-time imaging and identification of benign and malignant cellular structures inside pulmonary nodules and lymph nodes with needle-based Confocal Laser Endomicroscopy is not only feasible but highly reproducible,” said Pr. J. T. Annema, M.D., chairman of the Department of Respiratory Medicine, Amsterdam University Medical Centers, in a prepared statement. “The availability of nCLE inside the lungs has clear potential to have a major impact on the diagnostic accuracy for peripheral nodules, one of the most elusive challenges in the battle against lung cancer.”
The latest clearance comes on the heels of a mutual decision by Mauna Kea and Cook Medical to terminate a development and distribution agreement. The deal, originally inked in late 2015, included the development of Mauna Kea’s Cellvizio systems for urologic applications.
Mauna Kea received FDA 510(k) clearance in 2018 for its Celivizio 100 series F400 and F800 with Confocal Miniprobe, the CranioFlex. The clearance allows the device to be used during neurosurgical procedures.
“Interventional pulmonology represents a compelling market opportunity for Mauna Kea’s next clinical indication for commercial focus,” Mauna Kea CEO Robert Gershon said in a prepared statement. “We look forward to sharing our plans to evaluate this opportunity on our 2018 full year results conference call on March 20, 2019.”