The paclitaxel-eluting balloon luminor, is a double lumen catheter from the connector to the tip (also called over-the-wire, OTW) designed for percutaneous transluminal angioplasties of large peripheral arteries.
The guidewire runs into the circular-largest lumen while the elliptic-smallest lumen is intended for contrast medium flow.
The maximum diameter of the guidewire must not exceed 0.89 mm = 0.035 inches.
On the catheter’s distal part, just before the tip, there is the balloon (inflatable segment) that will dilate the artery upon inflating through the infusion of contrast fluid inside of it. The connector is Y-shaped and it has two entry ports:
· The straight port is intended for guidewire passage.
· The side port allows contrast medium flow to dilate the balloon
The balloon is coated with a homogeneous mixture of paclitaxel, a derivative of Taxol, and a physiologically innocuous matrix, the excipient. Drug’s dose is 3 µg/mm2 of balloon surface and it is intended to avoid cellular proliferation, consequently decreasing re-intervention rate.
The drug is released from the balloon by means of rapid inflation so that a high dose is released in a very short period of time. To assure a sufficient dosage of paclitaxel into the arterial wall, the inflation process must last from 30 seconds to 1 minute. Dilation of the lesion can be optimized by using longer inflation times at the operator’s discretion.
The balloon is designed to reach different diameters at different pressures, as predicted by the compliance curve included in the primary packaging.
Two radiopaque markers of Pt/Ir alloy are located at each end of the balloon to mark its length and help the user to see the catheter while navigating inside the patient.
At the distal end, there is the tip, made from a very soft polymer and rounded forming a non-traumatic shape to avoid damaging the arterial wall while navigating.
The shaft of the catheter is coated with a proprietary hydrophilic formula to minimize friction.