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[INSTITUTION] ADOPTS INNOVATIVE IMAGING AGENT TO IMPROVE
DETECTION OF CERTAIN BLADDER CANCERS
Blue Light Cystoscopy with Cysview® May Detect Certain Bladder Cancer Tumors
More than Use of Standard Diagnostic Technology
[LOCATION, DATE] – [INSTITUTION] is one of a select number of medical centers
nationwide offering Blue Light Cystoscopy with Cysview® (hexaminolevulinate
hydrochloride), an optical imaging agent for the detection of papillary cancer of the
bladder in patients with known or suspected bladder cancer. Cysview is the only FDAapproved imaging agent for use with blue-light cystoscopy.
[SAMPLE QUOTE:]
“Bladder cancer is difficult to detect and has a high rate of recurrence. An inaccurate
diagnosis can result in incomplete treatment, which may lead to serious complications
and a lower chance of survival for patients with potentially aggressive tumors,” noted
[PHYSICIAN SPOKESPERSON, TITLE]. “Blue Light Cystoscopy with Cysview
represents an important advance in diagnostic technology, enabling more accurate
diagnosis of bladder tumors compared to the standard technique.”
Bladder cancer is the sixth most commonly diagnosed cancer in the United States.(1)
The American Cancer Society estimates that 72,570 new cases of bladder cancer are
diagnosed in the U.S. each year.(2) [INSERT STATE OR OTHER LOCAL STATISTIC,
IF AVAILABLE]. Between 50 to 80 percent of patients will have their bladder cancer
recur, (1) making it the highest recurrence rate of any form of cancer.
Additionally, bladder cancer carries the highest lifetime treatment costs per patient of all
cancers, with 40 percent of the costs coming from surgical interventions to treat cancer
recurrence.(5) These surgical interventions to remove cancerous tissue are called a
transurethral resection of the bladder tumor (TURBT).(3) Based on a combination of
clinical data and economic analyses, a study showed that the five year cost for patients
who initially receive blue light cystoscopy as part of their TURBT were lower than those
patients who initially receive white light TURBT (6).
White light cystoscopy had been has been the gold standard for visualizing suspicious
lesions during transurethral resection of bladder tumor (TURBT). (4) However, when
used on its own, harder-to-see tumors can often be missed. Cysview, which is made by
Photocure Inc., is approved by the FDA for photodynamic blue light cystoscopy
performed with the KARL STORZ Photodynamic Diagnostic (PDD) system. Cysview
works by exploiting fluorescent properties of naturally occurring molecules in malignant
tissues. (7)
In Blue-Light Cystoscopy with Cysview,® the imaging solution (Cysview) is delivered into
the bladder about an hour prior to the cystoscopy and is absorbed by cancerous tissue.
Using the special PDD system, the doctor inserts a long thin tube into the bladder. After
first using white light, the doctor will switch to blue light mode. Because of the
preferential uptake of Cysview by malignant cells, other hard-to-see tumors that may be
present become more visible, standing out against normal bladder tissue and making it
easier for the doctor to identify and remove them.(7)
[SAMPLE QUOTE:]
“The availability of Blue Light Cystoscopy with Cysview is in keeping with our
commitment to advancing patient care,” said [INSTITUTION SPOKESPERSON].
“At [INSTITUTION] patients with known or suspected bladder cancer can now undergo
diagnostic procedures administered by physicians who have been specially trained in
the use of this innovative technology.”
About Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution
Cysview is 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.
About [INSTITUTION]
[INSERT INSTITUTIONAL BOILERPLATE HERE]
For more information about Cysview at [CENTER], contact [CONTACT NAME] at
[TELEPHONE NUMBER], or visit our website at [www.XXX.net].
Important Risk and Safety Information about Cysview®
Cysview is not a replacement for random bladder biopsies or other procedures used in
the detection of bladder cancer and is not for repetitive use.
Anaphylaxis reactions including anaphylactoid shock, hypersensitivity reactions, bladder
pain, cystitis, and abnormal urinalysis have been reported after administration of
Cysview. The most common adverse reactions seen in clinical trials were bladder
spasm, dysuria, hematuria, and bladder pain.
Cysview should not be used in patients with porphyria, gross hematuria, or with known
hypersensitivity to hexaminolevulinate, or in patients receiving intravesical chemotherapy
or BCG treatment within 3 months of Cysview photodynamic blue-light cystoscopy.
There are no known drug interactions with hexaminolevulinate; however, no specific
drug interaction studies have been performed. Using Cysview, fluorescence of nonmalignant areas may occur, and Cysview may fail to detect some malignant lesions.
Safety and effectiveness have not been established in pediatric patients. Cysview should
only be used during pregnancy if the potential benefit justifies the potential risk to the
fetus. It is not known whether hexaminolevulinate is excreted in human milk. Because
many drugs are excreted in human milk, exercise caution when Cysview is administered
to nursing mothers. No clinically important differences in safety or efficacy have been
observed between older and younger patients.
Cysview is approved for use 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.
CONTACT:
[NAME OF INSTITUTION MEDIA REPRESENTATIVE] [TELEPHONE NUMBER]
[E-MAIL ADDRESS]
###
1. (2013) General Information. Bcan.org Retrieved July 8, 2013 from
http://www.bcan.org/facing-bladder-cancer/frequently-asked-questions/generalinformation
2. 01/21/2013) How many people get bladder cancer?. Cancer.org Retrieved July 8,
2013 from http://www.cancer.org/cancer/bladdercancer/overviewguide/bladdercancer-overview-key-statistics
3. Witjes, Alfred & van der Heijden, Antoine. (2009) 556–562. Recurrence,
Progression, and Follow-Up in Non–Muscle-Invasive Bladder Cancer.
European Association of Urology. Retrieved July 9, 2013 from http://euacme.org/europeanurology/upload_articles/van%20der%20Heijden%20Se
pt%20Supp.pdf.
4. Goh AC, Lerner SP. Application of new technology in bladder cancer diagnosis
and treatment. World J Urol.
5. Lotan, Yair & Sleeper, Joshua. (2011). Economics of Bladder Cancer Diagnosis
and Surveillance. In Hautmann,S., Lokeshwar, V. & Merseburger,A. (Eds.),
Bladder Tumors: Molecular Aspects and Clinical Management. (121). New York:
Springer
6. Sievert, K.D et al. (6/27/2009). Economic aspects of bladder cancer: what are the
benefits and costs? World Journal of Urology. Retrieved on July 9, 2013 from
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2694315/
7. Frampton JE, Plosker GL. Hexyl aminolevulinate in the detection of bladder
cancer. Drugs. 2006;66:571-578.