KARL STORZ Endoscopy-America, Inc. (Tuttlingen, Germany) has been granted approval by the US Food and Drug Administration (FDA) for its new and improved Blue Light system to be used with Photocure ASA’s (Oslo, Norway) Cysview product in Blue Light Cystoscopy (BLC) procedures for the detection of non-muscle invasive bladder cancer (NMIBC).

Bladder cancer ranks as the seventh most common cancer worldwide and is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike. Bladder cancer is classified into two types, NMIBC and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder.

BLC uses the D-Light C Photodynamic Diagnostic (PDD) system along with Cysview, an optical imaging agent. The combined system is used to enhance the detection and management of NMIBC in patients with known or suspected bladder cancer, based on prior cystoscopy. Use of the technology begins with placement of Cysview into the bladder prior to the procedure, where it accumulates in tumor cells and is converted into porphyrins within the tumor. When viewed with the D-Light C PDD system, the tumor cells appear red or pink in contrast with the normal cells, which appear blue in color. The system is capable of delivering both conventional white light to illuminate the bladder during routine cystoscopy, as well as a special blue light to induce and view fluorescence after the placement of Cysview.

"The successful FDA approval is great news for the bladder cancer community in the US," commented Geoffrey Coy, Vice President and General Manager, North America at Photocure. "In healthcare, constant technical innovation is crucial, and we expect that this new, enhanced BLC system will fulfill our clients' expectations for improving the Blue Light experience. The new system is the next generation and includes practical features to make the technology more user friendly. We look forward to expanding the use of BLC with Cysview."

"At KARL STORZ, we are committed to helping our customers deliver top-quality care, and we believe that our new Blue Light system demonstrates this commitment," said Michael Lyman, Executive Director, Sales & Marketing, Urology and Gynecology, KARL STORZ Endoscopy-America. "The New Blue Light Powered by Saphira will allow us to serve the needs of our customers, providing next-level visualization to enable the right solutions for urological procedures in patients with Non-Muscle Invasive Bladder Cancer and continue our collaboration with the Photocure team to make high-quality BLC available to more patients in the US". 

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