KARL STORZ is releasing its PDD (photodynamic diagnostics) Blue Light Flexible Video Cystoscopy in the United States for detection of non-muscle invasive bladder cancer. The news is a result of the FDA’s regulatory green light that allows the company’s Blue Light Cystoscopy with Cysview to also be useful with the KARL STORZ PDD Blue Light Flexible Video Cystoscope.
The regulatory approval includes an indication for use of Cysview repeatedly on the same patient to spot Carcinoma in Situ, a difficult bladder cancer to diagnose. Of note, Cysview, an optical imaging compound that’s injected and fluoresces in pink, is manufactured by Photocure.
The new blue light system is flexible and so fairly comfortable for the patient, so much so that it does not require anesthesia during an exam.
Some study information on Blue Light Cystoscopy, according to KARL STORZ:
The FDA approval of KARL STORZ PDD Blue Light Flexible Cystoscopy with Cysview® (BLFCC) is based on results from a large Phase III study using the KARL STORZ blue-light-enabled rigid and flexible cystoscopes and blue light video system. During the Phase III clinical trial for Blue Light Flexible Cystoscopy, the following significant clinical findings were documented:
- BLFCC significantly improves the detection of patients with recurrence of bladder cancer (20.6%, p<0.0001).
- BLCC significantly improves the detection of patients who recurred with CIS (34.6%, p<0.0001).
- Repeat use of BLCC improves tumor detection in 46.2% of the patients and is safe.
Via: KARL STORZ…
Your information will never be shared with any third party.