The European Union has granted CE mark approval to Mauna Kea Technologies' optical biopsy probe for use in cystoscopy procedures to diagnose, treat and survey patients with bladder cancer.
The UroFlex confocal miniprobe, the first urological probe in the Cellvizio portfolio, provides physicians with an immediate view of cancerous cells within the bladder and ureter, aiding more informed treatment decisions.
Several clinical studies have demonstrated that optical biopsies with Cellvizio help urologists to determine if they have removed all cancerous cells during transurethral resection of the bladder tumor (TURBT), which reduces repeat surgeries for the patient.
Data also shows that optical biopsies can help physicians characterise lesions during long-term surveillance of bladder cancer patients, while the extra information the miniprobe provides can enable patients to go home earlier, avoiding unnecessary procedures and surgeries.
AUSL Modena urology professor and chairman and oncological urology EAU section chairman Dr Maurizio Brausi said; "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."
Mauna Kea Technologies CEO Sacha Loiseau said the CE mark extends the Cellvizio portfolio beyond the gastrointestinal tract and lungs into the field of urology.
"Urologists throughout Europe can now offer Cellvizio optical biopsies to their patients," Loiseau said.
"Once again, Mauna Kea Technologies takes the lead in making optical biopsies with Cellvizio available to a much larger population of patients and thus significantly increasing its potential market."
The European urology device is estimated to be worth €1bn.