8/14/2019 Paclitaxel Eluting Analysis

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Drug E luting Balloon Analysis

Dr. Alexander Ruebben

Aachen Resonance GmbH, Germany

The ELUTAX is a rapid exchange Percutaneous Transluminal Coronary AngioplastyProcedure (PTCA) catheter.

The Aachen Resonance®Elutax ©  Drug eluting Balloon is developed especially for coronaryarteries and venous by-pass as well as for small vessels in peripheral and supraaorticregions. The balloon is coated with 2.0 microgram paclitaxel / sqmm.

Paclitaxel is considered to be suitable for vascular disease because of its high molecular weight and lipophilic characteristics. However, the pharmacokinetics of paclitaxel in thevessel wall is still not published. In order to understand the therapeutic dose and to avoid over dosage, the aim of this study is to evaluate the paclitaxel tissue concentration over the time.

In order to be able to calculate the tissue paclitaxel concentration we started from the point

that once paclitaxel is delivered in the vessel wall the pharmacokinetic is the samenonetheless how the paclitaxel was delivered.

Once we agree on this important starting point we could compare all the available data inliterature of drug eluting balloons and on our animal tests.

The literature and our own results were based usually on paclitaxel levels generated after 1hour, 6 hours, 12 hours, 24 hours and 48 hours.

In addition to our results we added the values of tissue paclitaxel concentration over the timefrom Sequent Please and other competitors.

Overall more than 1000 raw data samples were considered.

To understand the type of curve we are looking for, it must be clear that the curve is not linear as the resorption and dissolution of a substance in the cell is a biological process.

The best curve, which describes the process in an optimized way is a Power function, afunction of the form f ( x ) =  x n , where n is a characteristic value for the physiological behavior.

The following curve could be calculated:

In order to calculate the values once we have one single time dependent tissue value we canuse the following:

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8/14/2019 Paclitaxel Eluting Analysis

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y = x-0.8

x = time in hours

y = paclitaxel level (concentration) in tissue

What we can do with this curve and values?

1) No need of further animal trials to measure the time-dependent paclitaxel tissue

level (concentration) for a prolonged time.

2) Possibility to analyze and evaluate the data of different products3) Possible paclitaxel tissue level (concentration) calculation of the first minutes

after drug delivery

4) Establishing criteria to decrease prolonged toxicity

5) Ensure safe endothelization time

6) Minimize toxicity when using long and large balloons

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