The new Vascular ClearWay™ Local Therapeutic Infusion Catheter is a revolutionary micro-porous PTFE balloon catheter designed for the removal of fresh, soft emboli and thrombi, and for intraluminal irrigation.

The ultra thin micro-porous PTFE Balloon material creates a soft conforming contact surface without mechanical disruption to the vessel or stent. The ClearWay catheter creates a unique low pressure fluid layer that surrounds the balloon, allowing more effective removal of clot or thrombus, without excessive stress and uncontrollable mechanical disruption seen with more traditional elastomeric devices. Traditional elastomer balloon catheters create high shear stress and excessive pressure on the vessel walls, which can cause damage to the flow surface or in some cases even rupture the vessel. The ClearWay Catheter is a low pressure irrigating balloon system and non-compliant balloon that limits the amount of mechanical stress on the vessel wall. Atrium's patent pending "KIP" (Kinetic Isolation Pressurization) technology maintains an infusion zone with controlled low pressure for maximized therapeutic treatment.

The strong, but soft PTFE material means that the ClearWay can perform its mechanical clot remover function, on a more effective and less traumatic manner than traditional embolectomy catheters. Classic elastomeric latex balloons can rupture or catch onto edges if they come into contact with a stent, or are over inflated in a highly tortuous location. The soft, but tough PTFE contact surface of the ClearWay catheter combined with its controlled irrigation reduces the chance of rupture when used in and around a deployed stent. This makes the new Atrium Vascular ClearWay catheter an ideal resource for irrigating medication in and around peripherally placed stents, and immediately following angioplasty.

Historically irrigating balloon catheters have been reported to cause significant damage to the intimal lay of the vessel by fluid jetting and high pressure in localized areas. High-pressure jetting has been reported to cause significant injury, including perforation. ClearWay’s unique local therapeutic infusion design minimizes stress to the vessel wall and gently irrigates fluids at low pressure, thereby minimizing damage to the vessel.

ClearWay is particularly useful for thrombolysis. By combining both mechanical and therapeutic “de-clot” procedures with the localized delivery of thrombolytics, fresh luminal clots and thrombus can be gently lysed. By localizing the thrombolytic agent specific to the targeted lesion, ClearWay can result in a more complete reperfusion result.