| How does the machine work? |
Please see brochure and abstracts from the IFU |
| How to provide the drug, e.g. Rapamycin, Taxol,
Estradiol, Tacrolimus, etc.? |
Drugs currently under investigation are drugs that have been
already filed as pharmaceuticals for the human use. These
drugs can be ordered directly at the pharmaceutical company
or from the clinic’s pharmacy and must be used in their pure
form. translumina GmbH can assist in providing addresses. |
| How to mix the drug with ethanol? |
Using standard sterile pharmaceutical techniques the drug
is mixed with the ethanol, by the clinic laboratory. It is
only allowed to use the solvent pharmaceutical ethanol (purity
> 99%)The solvent is available at the pharmacy or directly
from the chemical company, i. e. Sigma-Aldrich. |
| Why should ethanol be used only? |
The spray-nozzles and the drying mechanism are developed
for the use of ethanol. The coating process is validated for
ethanol only. Translumina guarantees the drying and coating
procedure only for solvent pharmaceutical ethanol. |
| What dosage should be used? |
For direct human use of the translumina technology the amount
of drug per cm² of stent surface should not exceed the amount
of drugs used in the current clinical trials. Should physicians
want to test higher dosages than already tested, the translumina
coating technology can be used to certain extent. A validation
should be done to prove the quality of the coating process
in which translumina can assist. |
| What is the capacity of the porous surface? |
Translumina has measurements with different amounts of Rapamycin
and Electron Microscope pictures of the stent surface. The
drug coated in the Magic Box on Yukon DES Pearl surface is
contained mainly in the micro pores, that go deepest to 10
micrometer, while the average is 2 micrometer. Additionally,
the increased surface gives a perfect adhesion of the drug. |
| What is the price of the drug? |
It depends strongly on the drug itself and the dosage and
the corresponding stent length. The price of Rapamycin would
add ca. 40-50 € for the stent length of 18 mm, the dosage
5 mg per 1 ml Ethanol. |
| What are the issues regarding the solution storage? |
When using Rapamycin, its solution should be stored in a
cool and dark place. Advices for the storage of the drug are
available from producers - pharmaceutical companies. |
| How often can the machine be used? |
High number of coating procedures is guaranteed, as specified
in the IFU. Translumina guarantees that the machine can be
used as often as allowed by a daily clinical routine without
any problems. |
| What is happening, if the machine is not working properly? |
The machine has several compute controlled steps. In case
of error, the display shows an message. In such case, one
should follow the instructions displayed on the display and
in IFU or call translumina hotline number 0049 180 5 98 94
00. |
| What is happening, if the error is irreparable? |
Translumina will provide a replacement immediately. |
| Which stent sizes can be coated with the machine? |
As specified in the product information on Yukon DES Pearl
surface, presently available are diameters 2.5, 3.0 and 3.5
mm, as well as stent lengths 8, 12, 16, 18, 20, 23 and 25
mm. |
| How to know the coating solution volume for the stent
size? |
There is a label on the stent cartridge indicating the corresponding
coating solution volume. This volume depends only on the different
stent length. |
| How to change the concentration? |
The concentration can be changed by increasing the drug
content in the solution. |
| What should be done before a new (not validated) pharmaceutical
substance is used? |
The translumina stent coating technology offers the possibility
to use different pharmaceutical substances and dosages. For
safety reasons, the coating process or each new substance
should be validated. In this case, we offer the clinic to
consult translumina R&D regarding the physical, chemical and
biological properties of the drug. |
| What can be done, if the volume in the syringe was too
high or too low, by mistake? |
Stent coating machine prior to the coating process is checking
the volume in the syringe. If the volume is out of tolerance,
the machine gives a warning on the display. Correction of
the volume is asked, and the user has the possibility to adjust
the volume prior to coating. |
| How long after the coating the stent can be used?
|
We advise to use the stent immediately after the coating
process. However, it is possible to postpone the implantation
of the coated stent. The storage of the stent system after
the coating process depends on the sensitiveness of the used
drug. For Rapamycin a max storage duration in a dark and cool
area can be possible up to 24 hours (see IFU). To keep the
sterility of the product a sterile area is necessary. |
| What is happening with the drug solution in the cartridge? |
The drug will be sprayed on the stent system. The procedure
starts directly at the stent’s beginning and stops at the
end of the stent. The amount of drug solution that is on the
stent system is approx 20% of the total solution volume in
the syringe. Out of that 20% of the solution volume, 1/3 is
on the delivery system, and 2/3 are on the stent itself. |
| How long does it take to coat a stent? |
It depends on the stent length. Maximum will be about 6
minutes for a longest stent (25 mm). The total time of the
complete process including unpacking, starting the process
and removing the stent system after the coating takes not
more than 10 minutes. |
| What happens after the coating procedure? Is it sterile? |
The coating process is fully sterile as well as the stent
system in the cartridge. The coating machine is connected
to the hospital air supply. During the coating process the
machine uses additional sterile filter delivered with each
YUKON DES which is mounted over the air connector to the cartridge,
which ensures complete sterility of the coating process. |
| What does the surface look like after the coating? |
It depends on the drug itself. The pores of the coated stent
are filled homogenously with the drug and the surface looks
very smooth (please see pictures in the brochure). |
| What is the release kinetic of the drug on the stent? |
The release kinetic is related to the choice of drug. Please
check literature for solubility of drugs in water. Comparison
with release kinetic from other drug coated stents may be
helpful. |
| What is the design of the Translumina stent? What
is the difference between YUKON DES Pearl surface and Yukon
Plus? |
The stent design is the same like the translumina Curare
Stent or the translumina Yukon Plus Stent, only the surface
is different, without changing other parameters significantly,
such as recoil or radial force. please see results of non-randomized
trials for CURARE Stent System N°1. |
| How to get additional information for the stent
coating technology? |
Please contact translumina Sales & Marketing offices in
Munich, via following contact numbers:
Tel. +49 89 210 289 0,
Fax. +49 89 210 289 29,
info@translumina.de
|
| What is the registration situation? |
All parts of translumina stent coating technology are CE
certified: Stent Coating Machine MAGIC BOX, YUKON DES, Yukon
Pearl Surface as well as the coating process itself, combining
the coating machine and the YUKON DES stent system. |
