Gain the edge
against bladder cancer
with Blue Light Cystoscopy
with Cysview®
Cysview® is clinically proven to detect non-muscle invasive bladder cancer (NMIBC) missed by white light alone.
About Cysview®
What is it?
Cysview is an FDA-approved product that makes bladder cancer tumors glow bright pink under blue light so urologists can remove them more completely than if they weren’t using Cysview.
Who is it for?
Cysview is for use in patients with NMIBC. It should be used for the first TURBT and for all intermediate and high-risk NMIBC patients during surgical treatment and surveillance/follow-up.
See the difference
With Cysview, NMIBC tumors are much more visible during a cystoscopy. In blue light, Cysview makes them glow bright pink.
BLC® with Cysview® offers many benefits
What is Cysview®?
Cysview is a pharmaceutical product that makes non-muscle invasive bladder cancer (NMIBC) tumors glow bright pink under blue light during a cystoscopy.1
It was approved by the US FDA in June 2010.
The Blue Light Cystoscopy (BLC®) procedure uses both white and blue light for enhanced visibility of NMIBC tumors.1
Indication
Cysview is an optical imaging agent indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder.
Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC®) as an adjunct to White Light Cystoscopy (WLC).
Why is there a need for Cysview®?
The standard technique for detection of bladder cancer, (WLC), can miss tumors that are there but not visible.2 When TURBT is performed with only white light, up to 75% of patients present with tumors at repeat TURBT.3
A complete TURBT is vital in NMIBC management for accurate tumor typing, staging and grading, which can impact optimization of patient outcomes.2 Additionally, the detection of additional tumors in surveillance may have a profound impact on diagnosis.4
When TURBT is performed with only white light
present with tumors at repeat TURBT3
How can Cysview® help?
BLC® with Cysview:
Helps enhance tumor margins, increasing confidence in complete resection.4,5
Is the most studied enhanced cystoscopy with the only mechanism of action that targets cancer cells.1,6
BLC with Cysview is FDA-approved for use in both TURBT and surveillance1 and is approved for use with a:
Rigid cystoscope
(operating room/TURBT procedure/follow-up)
Flexible cystoscope (office/surveillance/follow-up)
Cysview® during TURBT
BLC with Cysview offers optimal diagnosis right from the first TURBT:
Detects more tumors than white light alone.1
Better detection may lead to appropriate risk categorization.7
Cysview® in a surveillance setting
In the phase III study that resulted in the expanded Cysview indication to include patients undergoing surveillance cystoscopy for carcinoma of the bladder, results showed that Cysview significantly improves detection of patients with recurrent bladder cancer (p<0.0001).1 Experts recommend using BLC with Cysview for surveillance.7
Well-established safety profile with over a decade of data1
The most common adverse reactions reported in patients who received Cysview (≤2% of patients):
The following adverse reactions have been voluntarily reported 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:
Warnings and precautions:
- Anaphylaxis: have trained personnel and therapies available.
- Failed detection: Cysview may not detect all malignant lesions. Always perform WLC followed by BLC. Do not biopsy with blue light only.
- False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG therapy or chemotherapy.
How Cysview® works
Mechanism of action pathway8
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See the difference
Cysview may not detect all malignant lesions. False-positive fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG immunotherapy or intravesical chemotherapy.
References:
1. Cysview [prescribing information]. 2019:1–4. 2. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016;196(4):1021–1029. Amended 2020. 3. Cumberbatch MGK, Foerster B, Catto JWF, et al. Repeat Transurethral Resection in Non-Muscle Invasive Bladder Cancer: A Systematic Review. Eur Urol. 2018;73(6):925–933. 4. Daneshmand S, Patel S, Lotan Y, et al. Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. J Urol. 2018;199(5):1158–1165. 5. Witjes JA, Babjuk M, Gontero P, et al. Clinical and Cost Effectiveness of Hexaminolevulinate-Guided Blue-Light Cystoscopy: Evidence Review and Updated Expert Recommendations. Eur Urol. 2014;66(5):863–871. 6. Xiong Y, Li J, Ma S, et al. A Meta-analysis of Narrow Band Imaging for the Diagnosis and Therapeutic Outcome of Non-Muscle Invasive Bladder Cancer. PLoS One. 2017;12(2):e0170819. 7. Richards KA, Smith ND, Steinberg GD. The Importance of Transurethral Resection of Bladder Tumor in the Management of Nonmuscle Invasive Bladder Cancer: A Systematic Review of Novel Technologies. J Urol. 2014;191(6):1655–1664. 8. Wachoska M, Muchowicz A, Firczuk M, et al. Aminolevulinic Acid (ALA) as a Prodrug in Photodynamic Therapy of Cancer. Molecules. 2011;16(5):4140–4164.