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INFORMATION FOR
PATIENTS
Invatec Spa from Italy were granted CE mark, for the drug eluting balloon
In.Pact Amphirion for small vessels below the knee, by date of January 17,
2009.
It is very astonishing that this could happen!
The presented data to achieve CE mark were made on the basis of
Paccocath trials and based on the study named “Thunder Trial”, published in
“The New England Journal of Medicine”, vol.358:689-699, Febr.14, 2008.
Contrarily, in the webpage of Invatec, they name their coating “FreePac™
coating” attributing to it a special Proprietary hydrophilic coating formulation.
This is also confirmed by the fact that Bayer Schering Pharma AG, the patent-
owner of Paccocath, did not grant any license to Invatec to use the patent
method or to use their data.
Relevance of data
A literature review should clearly establish the extent to which the literature
relates to the specific characteristics and features of the device under
consideration.
If the published studies do not directly refer to the device in question, the
following must apply.
Technical:
-used under similar conditions of use;
-have similar specifications and properties eg tensile strength,
viscosity, surface characteristics
-be of similar design;
-use similar deployment methods (if relevant);
-have similar principles of operation
Biological:
-use same materials in contact with the same human tissues or
body fluids;
Not the same materials have been used, from the balloon material to the
compounds, especially no Iopromide has been used. Instead it was used
FreePac™ with a special Proprietary hydrophilic coating formulation.
To be equivalent, the devices should have similarity with regard to the clinical,
technical and biological parameters with special attention to the performance,
principles of operation and materials!
The Product In.Pact Amphirion for small vessels below the knee is a
device, which was never tested in humans before granting CE Mark the
outcome is totally unclear!