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Medical Journalist Site for Cysview

Medical Journalist Site for Cysview®

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Cysview case study

Cysview and Papillary Bladder Cancer Detection Video

Cystoscopy 

A cystoscope is a specialized endoscope allowing for direct visual inspection of the urothelium. The cystoscope is inserted through the urethra into the bladder. The endoscopy can be performed immediately after the cystoscope has been introduced into the bladder and the pictures generated by the integrated camera are transmitted onto a nearby video screen.
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Bladder Cancer

The standard bladder cancer diagnostic procedure combines urinary cytology and white light cystoscopy.1  Cytology is non-invasive, using a urine sample to detect cancer cells. This provides specificity and sensitivity in detecting high-grade lesions, but provides no information on the location and extent of the disease. 
 
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Clinical Aspects of Bladder Cancer

Urinary bladder cancer has a recurrence rate of between 50% and 75% at 20 years1 after treatment.

As a consequence, highly sensitive as well as specific diagnostic techniques capable of comprehensively detecting as many tumors as possible must be employed in order to ensure optimal treatment.

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View of bladder with white light cystoscope followed by view of bladder with blue light
cystoscope
Photo credit - Dr. Maximilian Burger, University of
Regensburg
 

Indications and Usage

Cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive  papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.  Cysview is used with the KARL STORZ  D-Light C Photodynamic Diagnostic (PDD)™ system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1).

Cysview is not for repetitive use and is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.


Product Risk Information:

Safety and effectiveness have not been established in patients receiving intravesical chemotherapy or BCG treatment within 3 months of Cysview photodynamic blue light cystoscopy, nor in pediatric patients.

The following adverse reactions have been identified during post-approval use of Cysview. Because these reactions are reported voluntarily
from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cases of anaphylactoid shock, bladder pain, cystitis and abnormal urinalysis have uncommonly been reported.

Cysview should not be used in patients with porphyria or with known hypersensitivity to hexaminolevulinate. There are no known drug interactions with hexaminolevulinate; however, no specific drug interaction studies have been performed.
 
Cysview must be used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system. For system set up and general information for the safe use of the PDD system, please refer to the Karl Storz instruction manuals for each of the components.

 

Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and reconstitution instructions.
 

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