FREEWAY™ 035 latest second-generation drug-releasing technology

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 are more resistant 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™ 035 Bioshell coating matrix consists of a natural resin, which is EMEA 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
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™ 035 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™ 035, peripheral PTA balloon 0.035" 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. Immediately 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™ 035 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™ 035 – 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™ 035 – OTW balloons for successful peripheral interventions

A treatment concept with extraordinary developed products

  • Wide spectrum of balloon catheters for treating long, diffuse lesions
    • - Up to 150 mm balloon length
    • - High rated burst pressure up to 16 atm for treating calcified lesions
  • Nominal pressure of 6 atm
  • Elaborated catheter technology with good crossability, trackability and pushability for treatment of diffuse lesions
    • - Dual-lumen shaft design with hydrophilic lubricious coating on distal shaft
  • Precise, controlled dilatation
    • - Controlled compliance for accurate balloon vessel sizing
    • - Flat shoulders
  • Short deflation time

Reach your destination with an enhanced FREEWAY™ OTW 0.035" balloon designed to cross smoothly and deflate quickly.

FREEWAY™ 035, peripheral PTA balloon 0.035" OTW

Eurocor’s latest, second-generation drug-eluting technology with an immediate short-term drug release effect

An innovative therapeutic treatment concept specifically designed for peripheral interventions

  • 4–8 mm balloon diameter
  • 20–150 mm balloon length for 4-7 mm and 20-100 mm balloon length for 8 mm diameter
  • 80 cm and 135 cm shaft lengths

FREEWAY™ 035, peripheral PTA balloon 0.035" 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