DIOR Paclitaxel coated coronary balloon dilatation catheter
DIOR PTCA Catheter is explained as a double Lumen coronary Catheter for a rapid exchange with a balloon that can be enlarged and two radiolucent targets (proximal and distal), to facilitate the balloon positioning under X-Ray fluoroscopy. DIOR PTCA Catheter is coated with Paclitaxel pharmaceutical active ingredients (3µg/mm²).
The outer lumen is used for balloon inflation and the inner lumen received a guidewire Ø 0.014” to facilitate the advancement of the catheter.
Two marker bands located on the inner member are used to indicate by fluoroscopy working length of the balloon. The tip soft and tapered to facilitate advancement of the catheter to and through the stenosis. The proximal part is a single-lumen made with a plastic tube and a stainless steel hypotube. Proximal visual markers located 90 cm and 100 cm from the distal tip aid catheter positioning in the guiding catheter using either the brachial or femoral approach.
Before: Evidence of a mutifocal ISR (Mehran ID) in the BMS stents previously implanted in the RCA, QCA: DVR: 3,21 mm MLD: 0,98 mm
FUP: QCA: DVR: 3,16 mm MLD: 2,98 mm Late Lumen Loss: 0,18 mm
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. DIOR PTCA 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
The excellent film forming properties of shellac are used to coat gastric resistant tablets.
The DIOR PTCA Catheter 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
(24 h extraction Cell grows and carries in cell culture medium)
Quantification of cell quantity
Metabolic cell activity (MTS-assay)
No signs of pro-inflammatory activation
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 DIOR PTCA 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.