Mauna Kea Technologies, the maker of Cellvizio, has announced the granting of the CE Mark and the pre-launch of a comprehensive range of probes aimed at endourological applications, to coincide with its first participation in the 107th French annual congress of Urology.
This range of probes will provide access to the flexible cystoscopy, rigid cystoscopy and ureteroscopy (CystoFlex, CystoFlex UHD and UroFlex probes respectively) procedures market.
Mauna Kea Technologies will focus its development on tumors of the bladder and the upper urinary tract, accessible by endoscopy and mainly affecting people over 50.
The conventional procedure to treat these types of tumor involves an initial endoscopic examination to detect bladder lesions (flexible cystoscopy procedure) and resection them (rigid cystoscopy procedure), before sending analyses to a laboratory, to gauge their aggressiveness and to distinguish superficial forms and infiltrating tumors requiring surgical resection.
Mauna Kea Technologies founder and CEO Sacha Loiseau noted this announcement follows the recent presentation of further major clinical results in the US concerning the use of Cellvizio in urology.
"Given the proven medical need and a substantial demand from the medical community for an improvement in urology procedures, we are confident in the clinical value that these new probes will provide in the treatment of bladder cancer and several new clinical studies will be conducted to provide supporting data.
"The market opportunity in urology is considerable and the Cellvizio Optical Biopsy platform, which now includes the EVA operating system and a range of miniprobes specifically designed for urology applications, is ideally positioned to address it," Loiseau added.
According to Mauna Kea Technologies, Cellvizio is the only optical biopsy system that can be used for numerous indications and that allows medical staff to assess tissue microscopically with no invasiveness and no limit on the number of optical ‘examinations’ carried out.
Use of the Cellvizio in urology is already authorized in Europe and is pending the US Food and Drug Administration clearance in the US. The CystoFlex UHD mini probe that has just been granted CE Mark completes the existing range of probes and opens the way for urological use in operating theaters.