IMPORTANT

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.

Any similarity with BBraun’s concept of mixture of paclitaxel with contrast

medium is not disclosed.

To achieve an uptake of paclitaxel into the vessel, the hydrophilic coating

formulation contains a new non proven drug. This product has no clinical data
at all and has never been studied in human patients concerning its biological
effect.

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.

The manufacturer must demonstrate equivalence in all the following

essential characteristics with the device, which is the subject of the
published reports. Equivalence means:
Clinical:
-used for the same clinical condition or purpose;
-used at the same site in the body;
-used in similar population (including age, anatomy, physiology);
-have similar relevant critical performance according to expected
clinical effect for specific intended use.
The application below the knee was not analyzed in these studies. The
presented trial “Thunder” has been done on femoral artery and popliteal
artery. Vessel anatomy and physiological parameters as diameter, blood flow
and risks related to drug embolism have never been discussed.
Also the size, the material and use of the investigated balloons was totally
different to the balloons which have been certified

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

In the webpage of Invatec they speak about FreePac™ with a special

Proprietary hydrophilic coating formulation.
Any similarity with BBraun’s concept of mixture of paclitaxel with contrast
medium is avoided.
The chemical property of the Contrast Medium Iopromide is missing.

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!