Amorphous Coating

Eurocor Tech`s drug-eluting balloons are all coated with a durable non-crystalline bioshell coating. This amorphous coating homogenously covers the balloon surface and protects the drug from mechanical abrasion and early wash off, resulting in a low paclitaxel blood plasma concentration.

The amorphous bioshell coating matrix consists of a 1:1 mixture of paclitaxel with shellac applied to the balloon surface by a micro-pipetting procedure in a clean room under sterile conditions. Paclitaxel is applied in a final concentration of 3 μg/mm².

Effect of Paclitaxel in the cell cycle

Paclitaxel

Paclitaxel is an active ingredient that inhibits the cell replication thus blocking the microtubules decomposition during the metaphase and anaphase stages of mitosis. By selectively inhibiting the proliferation of smooth muscle cells, paclitaxel does not influence non-proliferating cells.

Shellac

Shellac is a natural resin composed of shellolic and alleuritic acid. The excellent film forming properties of shellac are used to coat pharmaceutical products and in the food industry.

Molecular structure of Paclitaxel

Biodegradable Polymer – Sirolimus Coating

Eurocor Tech`s drug-eluting stent delivery systems are coated with the active pharmaceutical ingredient sirolimus within a biodegradable polymer matrix. The alliance of a fully biodegradable polymer, together with sirolimus efficiency to prevent restenosis, assures homogeneous drug distribution and uniform release kinetics.

Effect of Sirolimus in the cell cycle

Sirolimus

Sirolimus is an active ingredient with an antiproliferative and anti-inflammatory effect that is used to coat coronary stents. Sirolimus is the generic name of the natural product rapamycin, produced by strains of the bacterium Streptomyces hygroscopicus. Sirolimus inactivates the TOR protein and thus blocks transition from the G1 phase to the S phase in the cell cycle and therewith triggers an antimigratory and antiproliferative effect on vascular smooth muscle cells. Sirolimus also inhibits the pro-inflammatory immune cell activation.

Molecular Structure Sirolimus

Biodegradable Polymer

Eurocor Tech DES coating consists of a biocompatible and biodegradable co-polymer formulation. Eurolimus™ uses a PLGA 85/15 poly(lactide-co-glycolide) copolymer, while E-Magic™ Plus relies on PLLA & PLGA matrix.  Both polymer formulations have outstanding characteristics allowing a durable but thin coating layer on the stent surface, enabling a homogenous and controlled release of sirolimus.

Shellac has been used as an additive in the food as well as the pharmaceutical industry    for decades.

With the help of in-vitro experiments, it was found that shellac does not impair viability of Endothelial cells (EC) as well as smooth muscle cells (SMC). On further investigation, it was also shown to only not induce proliferation of SMC but also does not change the inflammatory status of  EC. Hence, shellac is suitable and safe for coating drug eluting balloons.

Shellac plays a vital role in forming the coating matrix for our DEBs.

Durable Amorphous Bioshell coating protects the drug from mechanical abrasion and early wash off.

The durable non-crystalline bioshell coating of Eurocor Tech`s drug-eluting balloons homogenously covers the balloon surface and protects the drug from mechanical abrasion and early wash off. Blood plasma has been tested following peripheral application with the FREEWAY™ as well as in coronary application with the DIOR®. The investigations resulted in low paclitaxel blood plasma concentrations. The results underline the safety of Eurocor Tech`s drug-eluting balloon coating technology.

FREEWAY™ DEB

• Compared to standard balloon dilation catheter, no delay in endothelialization nor any disadvantages in injury and inflammation score. Femoral arteries were compared winthin a timeframe of 32 ± 2 days .
• FREEWAY™ 035 DEB demonstrated safety and efficacy in a preclinical model of overstretch injury in peripheral arteries.
• Effective concentration of paclitaxel in the arterial wall after FREEWAY™ 035 DEB inflation.

DIOR® DEB

• Coronary arteries two weeks after dilatation, compared to standard balloon dilatation show no delay in endothelialization, nor any disadvantages in injury and inflammation score coronary arteries two weeks after dilatation.
• DIOR® DEB demonstrated safety and efficacy in a preclinical model of overstretch injury in coronary arteries.
• Effective concentration of paclitaxel in the arterial wall with DIOR® DEB inflation.