iVascular advises that product IFUs should be downloaded, issued and reviewed for operators reference before or during procedures with our devices.
The Paclitaxel-eluting balloon “essential” is a rapid exchange catheter (also known as RX) designed for percutaneous transluminal angioplasties of coronary arteries.
The body of the catheter features a combination of a single lumen at the proximal end and a dual lumen at the distal end.
On the catheter’s distal part, just before the tip, there is the balloon (inflatable segment) that will dilate the artery upon inflating by means of infusion of contrast fluid inside it.
The balloon is coated with a homogeneous mixture of Paclitaxel, a derivative of Taxol, and a physiologically innocuous matrix, the excipient. The 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 a rapid inflation so that a high dose is released in a very short period. In order to assure a sufficient dosage of Paclitaxel onto the arterial wall, inflation process must last from 30 seconds to 1 minute. Dilation of the lesion can be optimized by using longer inflation times at operator’s discretion.
The balloon is designed to reach different diameters at different pressures, as predicted by the compliance curve included on the primary packaging.
Two radiopaque markers are located at each end of the balloon in order to mark its length and help the user to see the catheter while navigating inside the patient.
The catheter ends in a cone-shaped tip
See IFU for further information. Available to download.
Dilatation of stenotic portions in coronary arteries or stenosis after bypass grafts which replace coronary arteries. Small vessels can also be treated, as well as residual stenosis after balloon treatment or endoprosthesis, and also pre/post-dilatation of endovascular coronary prosthesis, with the aim of improving myocardial perfusion.
Paclitaxel-eluting balloons have shown antiproliferative efficacy in the treatment and prevention of restenosis. Nevertheless, not all available devices are equally effective, which makes it interesting to compare results in a preclinical swine model (overexpansion 1.2 to 1.0). In this model, iVascular’s luminor 14 DEB significantly reduced in-stent restenosis compared with the control balloons. Study published in the Spanish Journal of Cardiology (Rev Esp Cardiol. 2014;67:456-62 – Vol. 67 Num.06) and available for download on website.