Wrong and Misleading Statements
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Discussuion about Statements from Dr. P. Stella during PCR- 2009 Session: Glimpse into the future – May 21 „Drug Eluting Balloons Background and Rationale“ Dr. Stella discolses his financial interest in beeing a member of the Advisory Board from Eurocor.
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Misleading Statements, from Eurocor Consultor Dr. Stella, Utrecht, The Netherlands, PCR 2009
Transcript of Wrong and Misleading Statements
Discussuion about
Statements from
Dr. P. Stella during PCR-2009Session: Glimpse into the future – May 21
„Drug Eluting Balloons
Background and Rationale“
Dr. Stella discolses his financial interest in beeing a member of the Advisory Board from Eurocor.
Statement Dr. Stella:
Fact:The Dior Balloon used in this trial was loaded with 2µg/mm2 paclitaxel and not as stated 3 µg /mm2
Statement Dr. Stella:
Fact:
The measured paclitaxel tissue concentration from the new Dior balloon is around 200 µM/L after 30 seconds see the data in his own presentation,
however Dr. Stella calculates only 0,3 µg/ml (slide from presentation Nr. 22)
The correct value is: around 171 µg/ml
A toxic effect is stated already with values over 50 µM/L
Statement Dr. Stella:
Fact:
Dr. Stella does not differentiate between the different balloon technologies which were used for DIOR.
The Dior balloon technology produced until May 2008 was loaded with 2µg paclitaxel/mm2 and was characterized by a microporous surface (schematic picture upper right „pink colored“, no additional compound was used.
The Dior actually sold by Eurocor uses a coating mixture with Shellac. No microporous surface is used and the Drug loading dose is of paclitaxel is 3µg/mm2
The biological aequivalence between both products is not given, therfore the trials and studies, which are presented by Eurocor to show the efficacy of safety of the Dior Balloon are only relevant fort he first Dior version not fort he actual one used today.
