ECLIPSE 2L occlusion balloon catheter - Catheter, intravascular, occluding

Intended purpose

ECLIPSE 2L catheters for occlusion are indicated to be used in the peripheral vascular system and neurovascular system for temporary occlusion. Balloon catheters provide a temporary vascular occlusion which is useful to stop or selectively control the blood circulation. Balloon catheters also allow a balloon-assisted embolisation of intracranial aneurysms. They are also indicated for: use in the peripheral vascular system for the perfusion of diagnostic agents (contrast liquids) and therapeutic agents (embolisation materials). Neurovascular use for the administration of diagnostic agents (contrast products) and therapeutic agents (embolisation materials) which have been approved or authorised for use in the neurovascular system and which are compatible with the internal diameter of ECLIPSE 2L balloon catheters.

Functional description

Double-lumen, single-use balloon catheters; 1 lumen for a guidewire & 1 for balloon inflation/deflation with inflation/deflation independent of guidewire position. The oval-shaped catheters have a constant proximal-side diameter & different balloon lengths; incorporate 3 radiopaque markers – 1 to facilitate distal end fluoroscopic visualisation & 2 to delimit the balloon’s cylindrical part; a short (3mm) or standard length (7mm) tip; & a distal hole to purge air from the balloon prior to use.