TransForm Occlusion Balloon Catheters - Catheter, intravascular, occluding

Intended purpose

The Stryker Neurovascular TransForm Occlusion Balloon Catheter is indicated for use in the neurovasculature to temporarily stop or control blood flow, for balloon-assisted coil embolization of intracranial aneurysms, and as an adjunct to the medical management of vasospasms or the treatment of refractory symptomatic cerebral vasospasms. The Stryker Neurovascular TransForm Occlusion Balloon Catheter is indicated for use in the peripheral vasculature to temporarily stop or control blood flow, and for balloon-assisted coil embolization of aneurysms.

Functional description

TransForm Occlusion Balloon Catheters are advanced into the vasculature and a mixture of saline and contrast is injected into the catheter lumen to inflate the balloon to its nominal volume while fluoroscopy is used to ensure the balloon is properly positioned at the treatment site. The balloon is deflated by aspirating fluid from the catheter while visually confirming deflation with fluoroscopy. The balloon can be re-inflated and deflated multiple times during a procedure.