Mauna Kea Technologies has received the European CE mark for the Cellvizio UroFlex confocal miniprobe, for use in cystoscopy procedures.
The company describes the device as the “first optical biopsy probe designed for urological applications”. It helps physicians diagnose and track bladder cancer using Mauna’s Cellvizio microscopy technology that so far been only used in gastrointestinal and lung biopsy procedures.
“Bladder cancer has a very high recurrence rate, and because it requires life-long surveillance and multiple repeat cystoscopy procedures, it is one of the most expensive cancers to treat on a per patient basis,” said Maurizio Brausi, MD, Professor and Chairman of Urology, AUSL Modena, Italy and chairman of the EAU Section of Oncological Urology. “With optical biopsies, physicians have an immediate view of cells within the bladder and ureter, which gives us a whole new set of data allowing more informed treatment decisions. This could allow us to more effectively determine if we have removed all the cancerous cells during minimally invasive surgery to reduce repeat surgeries for the patient.”
Clinical studies have demonstrated that optical biopsies with Cellvizio could help urologists determine if they have removed all cancerous cells during transurethral resection of the bladder tumor (TURBT)(iii)(iv)(v), the initial surgical procedure(vi) that a patient undergoes after the diagnosis of bladder cancer. The goal is to improve patient outcomes from the initial surgery and potentially avoid the need for a second TURBT procedure. Data also show that optical biopsies can help physicians characterize lesions during long-term surveillance of bladder cancer patients.