Device Dossier
Easy T - Angioplasty catheter, balloon dilatation, coronary, basic
Device Dossier for Easy T - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon dilatation, coronary, basic, Class…
- GMDN category: Angioplasty catheter, balloon dilatation, coronary, basic
Intended purpose
The PTCA Dilation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the prupose of imrproving myocardial perfusion. The balloon dilatation catheter is also indicatred for post deployment expnsion of balloon expandable coronary stents. THe PTCA dilation catheter is indicated for: - dilation of coronary artery stenosis - dilation of bypass graft stenosis - post dilatation of balloon expandable coronary stents
Functional description
A balloon is inserted into the vascular system, advanced through a guiding catheter over a guidewire to a stenotic coronary artery or coronary artery bypass graftand is inflated by means of aninflation device and contrast media under angiographic control, thus dilating the luminal diameter of the vessel. The catheter shaft contains 2 lumina. the inner lumen for the guidewire (distal only) and a an outer lumen along the whole length ofthe catheter used for balloon inflation with contrast media.