FDA Committee Vote Favorable to Hexvix

WEll thats where we should be going anyway..top cancer hospitals or university centers that deal with bladder cancer.
Thats what they are doing in Germany and the UK.
Let the local uro's keep their cash cow...prostate anything!!
Pat

Hi Pat

You are so right I did answer my questions. In speaking to the President of CDN Uro ASSOC. the problem with the light is cost, and logistics. He thinks you will only see this equipment at the top cancer and teaching hospitals.
This will create a numbers problem at these locations.
He thinks it will take a few years to sort everything out as these hospitals will need more qualified nurses and more Uros just because of demand for this procedure.
I will talk to Dr. Jewett about it in a few weeks and get his input.
Jack

Jack..you answered your own question!! That extra hour means probably hiring someone new to administer the dye and probably will put a kink in the local uro's offices for processing people through. My guess is the major cancer centers will have it as will the University centers. But WE can make a difference by demanding it. If they don't have it......go somewhere where they do. Who says we can't have a voice?
Pat

I wonder why the vote was only 9-8 in favour. Why were the 8 voting against?

This will increase the time for a cysto by at least 1 hour, as the Hexvix is instilled for 1 hour and then removed and then the cysto is performed.

I wonder how many hospitals will actually use this new light.

Jack

sara anne.....
“Hexvix Cystoscopy is a new diagnostic tool with improved sensitivity for detecting bladder tumours [over standard white light ]Cystoscopy], in particular CIS Tumours”, explained Professor Patrice Jichlinski, department of Urology, CHUV University-Hospital, Lausanne, Switzerland, lead investigator of a recent trial of Hexvix. Elaborating on the clinical results confirmed in several studies,[3,4,5] he added: “A statistically significant superiority of fluorescence cystoscopy over standard cystoscopy in the detection of CIS has been established in all published studies to date. Its high sensitivity and negative predictive value improves the diagnosis of malignancies and of CIS Tumours in particular. The cases missed by standard white light inspection were typically CIS lesions, confirming the superiority of Hexvix Cystoscopy in these cases. Tumour fluorescence is sparkling and well demarcated, whereas fluorescence from non-malignant tissue appears pinkish with an imprecise margin."

pat