Device Dossier

SeQuent Neo PTCA-Catheter - Angioplasty catheter, balloon dilatation, coronary, basic

Device Dossier for SeQuent Neo PTCA-Catheter - Angioplasty catheter, balloon dilatation, coronary, basic (Angioplasty catheter, balloon dilatation,…

Intended purpose

The SeQuent Neo is used in percutaneous transluminal coronary angioplasty (PTCA). The principle of PTCA is to enlarge the inner lumen of a narrowed vessel by means of an inflatable balloon, with expansion of the outer wall of the vessel. Indicated for Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts.

Functional description

A balloon-tipped, rapid exchange catheter with two lumina and radio-opaque markers. The balloon is protected with a removable sheath which protect the initial profile. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. SeQuent® Neo has a hydrophilic coated surface at the distal catheter portion. Due to this, SeQuent® Neo provide optimal gliding properties during intervention.

TGA Public Summary