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Paclitaxel
Paclitaxel prevents restenosis by blocking proper microtubal formation, thus it inhibits cell division and migration. It inhibits inflammatory processes. After balloon dilatation, injuries to the arterial wall stimulate inflammatory reaction, and the excretion of growth factors occurs as an important process along with the onset of cell division and the migration of smooth muscle cells. Paclitaxel inhibits platelet derived growth factor (PDGF) mediated vascular smooth muscle cell migration to the intima. Paclitaxel also inhibits extracellular matrix secretion and breakdown.
What is most important
Paclitaxel selectively inhibits the proliferation of smooth muscle cells. The endothelium cells show a better resistance to Paclitaxel than the smooth muscle cells due to the different affinity of the connective structure on the cell surface. Paclitaxel does not influence non-proliferating cells as a result of cytokine and growth factor stimulation. The FREEWAY Paclitaxel-releasing PTA balloon dilatation catheter enhances a smooth re-endothelialization process.
Axel et al. Circulation 1997.
Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and vivo using local drug delivery.
Circulation 1997; 96:636-45
Shellac
The excellent film forming properties of shellac are used to coat gastric resistant tablets.
The FREEWAY™ 014 Bioshell coating matrix consists of a natural resin, which is EMA and FDA approved (GRAS) as food additive under E 904.
Investigation of cytotoxicity
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Shellac extraction product
(24 h extraction in cell culture medium)
Quantification of cell quantity
Metabolic cell activity (MTS-assay)
No signs of pro-inflammatory activation
IL-8-release
Shellac extraction products (24 h) Exposition of confluent HDMEC with extraction products (24 h) tumour necrosis factor α (TNFα ) as a positive control group
Peters K, Prinz C, Salamon A, Adam A, Stuhldreier G, Rychly J, Neumann H-G.
Evaluation of shellac as coating of intravascular devices –
Testing of in vitro compatibility by endothelial and smooth muscle cells.
Jahrestagung der Deutschen Gesellschaft für Biomaterialien, 8.-10.10.2009, Tübingen
Neither direct contact to shellac-coated materials nor exposure to shellac extraction products impaired HDMEC and hSMC viability and function in vitro.
Shellac is a natural resin composed of shellolic and alleuritic acid.
The coating consists of a 1:1 mixture of Paclitaxel with shellac applied to the balloon by a micro-pipetting procedure in a clean room under sterile conditions.
*Very smooth surface – less vulnerable to abrasion
The FREEWAY™ 014 Paclitaxel releasing balloon catheter
In contact with body liquid the hydrophilic shellac-network of the composite swells and opens the structure for the pressure-induced fast release of Paclitaxel on the inflated balloon.
FREEWAY™ 014, infrapopliteal PTA balloon 0.014” OTW
How it works
PTA causes vessel wall injury. Hyperplasia of the inner vessel wall resulting in lumen narrowing is the natural reaction to this injury. After the ‘controlled injury’ set by the angioplasty procedure the key pathways start to contribute to the formation of neointimal hyperplasia. Due to injury from cracking plaque material, neointimal hyperplasia can slowly narrow the lesion, causing massive neointimal proliferation in treated lesion area.
After predilatation, the FREEWAY™ 014 Paclitaxel releasing PTA balloon is advanced to the lesion site.
With the balloon well positioned, inflation for at least 60 seconds releases the anti-proliferative drug.
The balloon is withdrawn as the drug penetrates into the artery wall. Paclitaxel will act immediately, over a short term, to inhibit cell re-growth. The shellac coating remains on the balloon.
The science of FREEWAY™ 014 – shellac conclusion
1:1 mixture Paclitaxel with shellac: proven and safe short-term drug release
Paclitaxel is applied in a final concentration of 3 μg/mm2 to the surface of the balloon.
Tissue concentrations of Paclitaxel reached by this coating is inflation time dependent.
After 60 seconds of balloon inflation a concentration of 200 μM/L is reached.
Posá et al.: Catheterization and Cardiovascular Interventions 76:395-403 (2010)
It is important to mention that after 120 seconds of balloon inflation time this concentration is even more than doubled.**
For peripheral treatments Eurocor recommends at least two minutes of inflation time; in severe cases it should be considered
to prolong the inflation time up to 180 seconds (in-stent restenosis and infrapoploteal lesions).
** Eurocor data on file
FREEWAY™ 014 – OTW balloons for successful infrapopliteal interventions
A treatment concept with optimal developed products
- low balloon crossing profile
- low tip entry profile
- short deflation time
- hydrophilic shaft coating
Reach your destination with an enhanced OTW 0.014” balloon designed to cross smoothly and deflate quickly.
Balloon crossing profile
Low-primary crossing profile - excellent trackability and flexibility
Low-profile tapered tip for easier lesion crossing - excellent crossability and navigation of infrapopliteal vessels including case of challenging anatomy
Greatly reduced deflation
Superior deflation time compared to competition - for fast and safe treatments
FREEWAY™ 014, infrapopliteal PTA balloon 0.014” OTW
Latest, second-generation drug-eluting technology with an immediate short-term drug release effect
An innovative therapeutic treatment concept with excellent trackability for challenging infrapopliteal lesions
Ultra-low profile balloons specifically designed for infrapopliteal interventions
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- 2–4 mm balloon diameter
- 40–150 mm balloon length
- 120 cm and 150 cm shaft lengths
FREEWAY™ 014, infrapopliteal PTA balloon 0.014” OTW
An innovative concept with many benefits:
- Delivers drug locally over a short period of time
- Avoids chronic inflammation
- Simplifies the procedure – is as easy to use as a standard PTA balloon catheter
- Crosses lesions smoothly due to the low profile
- Respects original vessel anatomy
- Treats lesions where stents are not a viable solution
- Allows short-term antiplatelet therapy
- Reduces the incidence of restenosis
- Enables re-intervention
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The Eurocor way of science for better patient results