Embolic Protection

embolic_protection_Proxis_hero250Patients with saphenous vein coronary bypass grafts have undergoing bypass surgery during which the saphenous vein from the leg is sutured to the aorta and the coronary artery to create a new  passage for blood flow. If the saphenous vein graft (SVG) develops a lesion, a percutaneous coronary intervention (PCI) procedure is often performed . Embolic protection systems are used to catch   debris that can be dislodged during a PCI. If debris escapes and flows downstream, it increases the risk of heart attack even if the coronary intervention is successful. Due to this fact, PCIs involving patients with saphenous vein grafts have been associated with significant complication rates.

Embolic protection system places a sealing balloon proximally, or upstream, to the lesion. The inflated balloon temporarily suspends blood flow so a guidewire can cross the lesion without sending debris into the bloodstream. An interventional device (such as a stent) is then delivered and the embolic debris is removed (aspirated) from the vessel. Once the intervention is complete, the balloon is deflated, blood flow is restored and embolic protection system is removed.

 TheraGenesis pioneered initial clinical studies of this concept leading to both CE-Mark and FDA approval.