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FREEWAY™ 014 Paclitaxel Eluting Peripheral Dilatation Catheter

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VENDOR: Eurocor Tech GmbH

$550.00
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Qty < 1000
1000 < Q < 2000
2000 < Q < 5000
Qty > 5000
PRODUCT INFORMATION
CUSTOMER REVIEWS
PRODUCT INFORMATION

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 an 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.

 

 

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

Shellac extraction product

Shellac extraction product
(24 h extraction in cell culture medium)


Quantification of cell quantity

Quantification of cell quantity
Metabolic cell activity (MTS-assay)


IL-8-release

 

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.

Shellac Bilder

*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.

Balloon Catheter

FREEWAY™ 014, infrapopliteal PTA balloon 0.014” OTW

How it works

Hyperplasia

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.


PTA Balloon release

After predilatation, the FREEWAY™ 014 Paclitaxel releasing PTA balloon is advanced to the lesion site.


Inflation

With the balloon well positioned, inflation for at least 60 seconds releases the anti-proliferative drug.


Drug into artery wall

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).

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

Tip entry profile

Low-primary crossing profile - excellent trackability and flexibility


Tip entry profile

Low-profile tapered tip for easier lesion crossing - excellent crossability and navigation of infrapopliteal vessels including case of challenging anatomy

Tip entry profile


 

Greatly reduced deflation

Moan 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

  • 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

Technical data

FREEWAY 014 – latest, second-generation drug-releasing technology,
0.014” OTW infrapopliteal PTA balloon technology specifically designed
for infrapopliteal interventions

 

FREEWAYTM014 : DEB
Design Coaxial design - over the wire catheter (OTW)
Shaft diameter dis. 3.1 F / medial 3.8 F / prox. 3.8 F
Balloon diameter 2.0 / 2.5 / 3.0 / 3.5 and 4.0 mm
Balloon length 40–150 mm
Usable catheter length (tip to strain relief) 120 cm and 150 cm
Guide wire diameter 0.014" (0.36 mm)
Coating Hydrophilic coating on distal shaft
Balloon material PA, Polyamid/Nylon
Balloon folding Bi-fold for 2.0 mm
Tri-fold for 2.5 to 4 mm
Balloon characteristic Semi-compliant
Recommended introducer sheath 4 F
Nominal pressure 6 atm
Rated burst pressure Diameter 2.0–2.5 mm: 16 atm/bar
Diameter 3.0–4.5 mm: 14 atm/bar

 

Country of Origin 

Made in Germany


Certificates

  • ISO
CUSTOMER REVIEWS
Contact us
Europe & America
Philip Pabst
p.pabst@aumet.me
+971 50 950 9178
Asia
Liang Ye
l.yu@aumet.me
+86 138 1030 9367
International
Sara Mansour
s.mansour@aumet.me
+962 7 9193 2594
FREEWAY™ 014 Paclitaxel Eluting Peripheral Dilatation Catheter

FREEWAY™ 014 Paclitaxel Eluting Peripheral Dilatation Catheter

$550.00
Qty < 1000
1000 < Q < 2000
2000 < Q < 5000
Qty > 5000
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